Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
ResponsibilitiesActs as legal advisor for at least one key and/or a combination of Global Corporate Functions (examples listed below but may include others) that encompasses all areas of the business of Daiichi Sankyo in the U.S. and globally as assigned. Specific assignment to be determined by direct manager of the role.Global Human Resources (including Benefits) Acts as the legal advisor for Human Resources groups within DSI and global legal entities, managing other internal and external legal counsel providing services in this area. Analyzes, applies and provides legal advice and counsel. Provides legal advice on employment law areas such as FMLA, ADA, FLSA, ADEA, employee privacy, state laws on wrongful discharge, wage and hour claims, contingent worker issues, diversity initiatives and workplace environment issues. Supports internal investigation, drafts employment separation agreements and provides guidance on restructurings, employee relations as well as compensation and benefits plans. Develops contract templates, reviews agreements, and manages outside counsel as necessary.Global Corporate Communications Acts as legal advisor for Corporate Communications groups within DSI and global entities, providing legal advice on media relations, internal communications, public disclosures, social media policies, compliance, crisis communications, and diversity initiatives. Develops contract templates, reviews agreements, and manages outside counsel as necessary.Global Government Affairs Acts as legal advisor for Government Affairs groups within DSI and global entities, advising on legislative and regulatory compliance, lobbying activities, political contributions, public policy development, and state and federal compliance. Develops contract templates, reviews agreements, and manages outside counsel as necessary.Global Finance Acts as legal advisor for Global Finance groups, supporting Oncology Business Unit, Research and Development Unit, and other functions. Advises on issues related to financial transactions, procurement, financial operations, securities, tax, financial audits, real estate, and facility management. Develops contract templates, reviews agreements, and manages outside counsel as necessary.IT/DX Acts as legal advisor for Global Information Technology/DX, providing legal advice, preparing legal documents, negotiating contracts, assessing security and technical provisions. Advises on issues related to data privacy, data management and Artificial Intelligence. Develops contract templates, reviews agreements, and manages outside counsel as necessary.Global Compliance Acts as legal advisor for the Compliance function within DSI and other global legal entities, providing legal advice and support tailored to pharmaceutical compliance. Provides legal support for maintaining an effective compliance program, including legal review and support for policies, training, monitoring, and auditing projects. Ensures adherence to pharmaceutical industry regulations. Develops contract templates, reviews agreements, and manages outside counsel as necessary.Global Business Development Acts as legal advisor for Business Development, handling legal aspects of licensing, co-promotion/co-development, strategic/financial investments, companion diagnostic, academic research organization, and acquisition deals. Advises senior management on legal and regulatory issues, leads complex transactions, and supports other agreements. Develops contract templates, reviews agreements, and manages outside counsel as necessary.
Other Corporate Functions or areas, as assigned.Leads or participate as legal support for cross-functional project management teams set up to address mid-sized to large Company-driven initiatives or special projects relevant to assigned Corporate Functions. Projects may be internal to the Company as well as project involving external business partners and/or other entities. The result of such initiatives may include creating corporate-level policies, guidance documents (i.e. standing legal risk analyses), and training of Company employees, as well as implementation of systems or processes.Monitors current developments in assigned key legal areas and provides Senior Management and other business leaders with updates regarding same (including Legal Affairs Department colleagues). Works independently and, as appropriate, in collaboration with other departments in developing, implementing and presenting training materials on various legal issues pertaining to assigned business areas. Such training materials may be presented to functions supported by this position (or by them) but would also be available for use by the Legal Affairs Department generally.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)Bachelor's Degree requiredJD from law school of recognized standing, and Bar admission requiredExperience Qualifications7 or More Years post-law school experience required4 or More Years pharmaceutical industry experience, particularly supporting specific assigned business areas in contracting, general legal advice, policy development and/or review, etc. in specific business support functions (e.g., HR, IT, Compliance Program, etc.) in an in-house capacity, as a legal consultant, and/or at a law firm in a practice group focusing on pharmaceutical industry and/or specific corporate business functions; 7+ years preferred required Licenses and CertificationsEligible to practice law in the state of New Jersey (either licensed in NJ or limited in-house license) and maintain such license in good standing at all times. required TravelAbility to travel up to 5% Occasional travelDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary:Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical products.
Responsibilities: CDx development: Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and after CDx testing, for less complex projects.At the time of implementation of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as the Point of Contact (PoC) for gathering country/region specific CDx RA requirements from local RA team members (e.g. from Japan, China, Australia, Canada, Korea etc.)For recruitment in EU: It is critical that this person has, and continues to develop regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR requirements to enable and support timely registration of both therapeutic and diagnostic products in the EU as well as UK and Switzerland. CDx RA Strategy: Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (e.g., Diagnostic Development Teams) and to external diagnostic business partners specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both submission to CDRH in a Q-sub process and in a streamlined fashion within protocol submission to CDER via the INDs), IDEsBiomarker strategies towards patient selection, patient stratification, bridging between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.Clinical trial protocol development and reviews (clinical trial protocols and medical device protocols)ICF reviews to ensure adequate disclosure for collection, retention, testing and retesting of samplesProject Team Participation: Provide device-specific regulatory insight/guidance during CDx Indication Team Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to communicate key RA updates from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with the creation of contingency/backup plans for CDx submission. Health Authority Submission Preparation : Assist with preparation of pre-submission documents and CDx related portions of therapeutic marketing applications and respond to regulatory queries/feedback from HAs. Contribute to providing timely feedback for Dx Partners to address regulatory questions from Global Health Authorizes (HAs) during review of device submissionsIn collaboration with CDx lead work with Dx partners to ensure robust development of assay, participate in HA interaction for drug-related CDx topics/questions, and attend device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key questions and company positions related to CDx for Health Authority interactions (for both sponsor and partner side) CDx RA Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these changesAssessing the impacts of relevant drug and diagnostic regulations on the development and registration activities for the respective medical productsQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)Bachelor's Degree requiredMaster's Degree preferredAdvanced degree in Pharm D, MD, PHD preferred Experience QualificationsExperience Qualifications:4 or More Years Solid scientific background Understanding of scientific content and complexities and good knowledge of diagnostic development, including extensive experience of IDE submissions and approvalsExtensive experience developing companion diagnostics and devices.Experience of drug development and drug regulatory procedures.Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives. Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies requiredTravel: Ability to travel up to 10% Occasional travel to Health Authority meetings in US and Europe, potentially JapanDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary:The primary responsibilities of this position are to assist in the development and implementation of companion diagnostics (CDx) strategy in support of projects and Global Project Teams within Daiichi Sankyo's Early and Late-Stage Development Portfolio. The individual will play a key role in making Precision Medicine a reality for patients who are likely to benefit from our therapeutics.Responsibilities Contributes to CDx project teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or under the guidance of the CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch. May act as CDx representative to GPT for early-stage programs.Assists CDx GPT representative by collaborating cross-functionally to ensure successful implementation of the CDx and associated data collection. Oversees clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug regulatory submissions.Contributes to CDx Partner evaluation and selection activities and manages multiple Companion Diagnostics Partnerships to develop, implement and gain regulatory approvals for CDx assays. May function as the main point of contact to the Dx partner for CDx project contracts. Supports CDx analytical and clinical validation studies in collaboration with Dx-partnerProvides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globallyFor late-stage programs, executes the Diagnostic development strategy for a project under the direction of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and by tracking and understanding the competitive landscapeQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education:BS/BA requiredMS preferredPhD preferredExperience:Minimum 4 years relevant work experience with PhD required OR minimum 7 years relevant work experience with MS required OR minimum 11 years relevant work experience with BS/BADemonstrated track record of success working on multidisciplinary pharmaceutical /diagnostic development teams requiredUnderstanding of the IVD Development Process, with indirect or direct experience with Companion Diagnostics Development requiredBroad knowledge and understanding of established and new assay technologies such as NGS, IHC, PCR etc requiredAn understanding of how diagnostic development can shape drug development and commercialization is a plus.Competencies:Ability to work in a highly collaborative environment globally with stakeholders from multiple functional areas.Strategic and analytical skills with a proven ability to define, prioritize and balance responsibilities in accordance with business and team needs.Experience maintaining strategic direction while ensuring successful execution of project details.Solid interpersonal and verbal and written communication skills with the ability to effectively communicate within project teams and at managerial levels of the organization across various functions and locationsTravel:Domestic and international travel may be required: up to 15%Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary:The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function within R&D. Reviews and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees and is accountable for innovation, standards, processes and infrastructure in RBQM. Accountable for selection and oversight of external vendors within technical scope. Will also be responsible for the internalization and oversight of the RBQM model. Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for the management, performance, and development, both technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance.This position requires excellent project and people management skills, verbal/written skills, analytical, organizational, and interpersonal skills and works effectively with people at different levels and from different disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically interface with technical teams in other functions to triage monitoring or other actions with the investigational sites. Additionally, this position possesses adequate knowledge of drug development in pharmaceutical industry across different disease areas, and the ability to determine risk factors with and for other technical departments (eg, Clinical, Medical, Safety, Data Management, Statistics). This position requires skills in working in a fast-paced environment, continuous improvement, change management, and risk management. Experience working and managing CROs in the RBQM space is also required.
Responsibilities:
- Group strategy: Sets the vision and strategy for the group including overall vision for a robust risk assessment, mitigation, central (statistical) monitoring and signal detection. Identifies areas to be improved and initiates rectification or remedial activities. Develops the strategy for technology and innovation to improve the overall efficiency in project execution and deliverables. Oversees or initiates RBQM operating procedures and standards; monitors and enforces compliance of standard procedures and processes. Proactively manages resource planning to ensure adequate resources are available to business priorities.
- RBQM Strategy: Establishes and drives standard RBQM strategy, provides strategic or tactical input to the RBQM projects. Communicates and collaborates with other function leaders during this process to support decision making and execution. Develops overall outsourcing strategy for the function including internalization strategy and execution plan. Responsible for developing, implementing, and maintaining the plan to internalize RBQM efforts while overseeing the 3-way model for ongoing/near term new trials.
- External Vendor Oversight: Manages higher-level negotiation with external vendors. Provides oversight of quality/performance and budget, resources and timelines across the department and ensures timely delivery of high-quality deliverables at reasonable cost. Provides documented oversight of the external vendors/sponsor partnership under the RD-wide vendor oversight structure. Strategically leverages external expertise in supporting RBQM activities.
- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to Quality factors, select critical variables and processes, and build appropriate mitigations. Drive interface with Integrated Data Review, Data Surveillance, targeted source document verification and targeted source data review. Lead the team to develop and implement metrics including Quality Tolerance Intervals, Key Risk Indicators, Key Performance Indicators, and grouped variables for signal detection. Articulate to Study Team for appropriate site and study level triage, actions, and rectifications.
- Deliverables: Working with RBQM leaders to provide oversight of activities performed by the internal RBQM function in association with other DS functions, or any vendor outsourced roles on RBQM behalf. Advises, directs, prioritizes, and monitors all RBQM activities and deliverables in terms of timeline and quality.
- People Management Leadership: Accountable for the management, development, recruitment and training of employees within the departmental scope to meet current and future business needs. Provides exceptional leadership to employees within responsible areas. Leads coaching and development of employees across the function. Provides leadership by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. Manages and provides guidance to team members, including organizing and prioritizing group tasks, performing training, and managing performance. Responsible to create an environment where employees feel engaged and empowered, and take pride in their roles, responsibilities, and deliverables.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)
- Master's degree in life sciences, data science, statistics, or related field required
- PhD in life sciences, data science, statistics, or related field preferredExperience Qualifications:
- 11 or more years of experience in RBQM and/or related work experience in pharmaceutical company, Biotech, or similar environment (e.g., CRO). required
- 5 or more years managing people required
- 5 or more years managing projects required
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary:This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for supporting CSO Project Management Leads by developing and updating Study Supply Plans, managing various work streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.Responsibilities:Develops and updates Study Supply Plans in close communication with CSO project Management Lead.Responsible for the Clinical Label Development process which includes creation of master label text, translations, and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.Vendor Management -supports Person in Plant (PIP) activities when packaging operations for DSI are in-process. Supports investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to ship.Assists in the creation of SOP's and work instructions specific to CSO Supply Planning as requested.Responsible for updating relevant Trial Master Files (TMF) with CSO-related documents.Supports the CSO Project Mgmt Lead in executing additional operational and logistical duties as discussed and agreed to by management.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): Bachelor's Degree requiredPharmD or related field preferredMaster's Degree preferred Experience Qualifications: 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development. preferredOncology experience preferredCreation of Supply Planning tools preferredAbility to travel up to 10% Overnight / single-day travel will be required to go to outsourcing vendors from time to time infrequently. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary:Senior clinical operational leader accountable for operational planning and execution of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study design, operational planning, start-up, conduct, reporting, and close out) including timeline, quality, and budget management. Drives and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program management, leadership, decision-making ability, people management, and organizational skills and expert level written and verbal communication skills. The role is primarily responsible for Operational Program Strategy and Execution and will have the responsibility of managing multiple direct reports.Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for successful implementation of studies. Responsible for management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams in their therapeutic area.Ensure operational aspects are incorporated into CDP planning and individual protocols to facilitate successful implementation of programs.Clinical Operations:Ensure high quality delivery of all studies for which they are responsible. This includes individual studies as well as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated study plan and create initial study budget. Review study feasibility assessments provided by the CRO(s), lead the CRO selection process and provide input into ARO selection.Validate the study implementation plan provided by the CRO through to study close out and CSR writing. Ensure the timing of the major study milestones and the associated budget meet the needs of the overall development plan agreed to by the Global Project Team (GPT).Lead site selection and site qualification discussions, kick-off meetings and study team meetings.Oversee the CRO and provide timely input to ensure that the study is executed according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans.CRO and Quality Oversight:Responsible for oversight of all CROs utilized within their therapeutic area. May represent Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all studies falling under their responsibility.Design, update and implement appropriate innovative and best-in-class procedures and SOP's related to clinical study oversight and execution.Work with TMF Operations to ensure a state of inspection readiness for all TMFs and ensure quality expectations are met.When sitting on a study team, responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at an overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to the appropriate governance committee.Create the budget at study start up, and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders to ensure team awareness of the CRO scope of work (to minimize unwarranted change orders) and budget, so both can be managed appropriately.Provide oversight of the CRO to ensure compliance with Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log) and other risk related plans and ensure study team adherence and utilization. Be aware of and be able to predict deviations or potential noncompliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate to appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve or escalate accordingly.People and Resource Management:Responsible for resource management within their therapeutic area. Management requires review of resources against development pipeline to identify areas of resource gaps or excess. Management includes appropriate use of DS employees and contractors to ensure adequate staffing at all times.This position may require the supervision of functional and/or direct reports. In addition to providing instruction, direction of daily activities in support of goals, the supervisor will conduct a performance evaluation against development goals and career path requirements for their direct reports. The supervisor should coach and guide their functional and/or direct reports in support of their development needs, and facilitate conflict resolution on their behalfQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education: Bachelor's Degree in the Sciences requiredExperience: 10 or More Years relevant experience required4 or More Years with a MS/MPH preferred4 or More Years with PharmD/PhD preferredExperience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). preferredCRA experience preferredTime spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. preferredTravel:Ability to travel up to 20% In-house office position that may require some travel (domestic or global).Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
JOB SUMMARY
The Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the implementation of a quality strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit (SBU) Medical Affairs business strategy . This individual is also accountable to promote a quality culture within across the product portfolio by providing governance support, quality oversight of strategic initiatives in close collaboration with cross functional leadership team (ie, OBU, SBU) and study teams to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials and managed access programs to the highest quality standards.
This position reports to the Head, Global Development and Medical Affairs QA RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global Quality teams located in EU, Americas (including Brazil) and work in close collaboration with Japan. This individual is a member of the Development and Medical Affairs QA leadership team and maybe extended member of the global RD/PV QA leadership team. The position will represent QA at Global Oncology Medical Affairs LT, Specialty MA LT, Development (as applicable), GMP QA, and engagement with external partners as deemed necessary.
This position is accountable to drive a proactive approach to quality and instilling a shared passion for building a stronger Quality organization with One Quality voice as the best trusted quality partner with internal and external stakeholders. The incumbent must aim to instill a consistent quality mindset and culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies.
Provide comprehensive quality oversight and strategic quality guidance/advice to the MA functions located in the Americas and EU and collaborate with Research QA and Development QA to provide QA advise wherever necessary for shared services between R&D and Medical affairs, particularly in case when issues impact Medical Affairs programs. Ensure requirements are in place for quality oversight of marketed products in collaboration with Research QA, PV QA, CSPV and other internal QA stakeholders such as GMP QA, specifically for specialty pharmacy, REMS, co-partners and affiliates.
Liaise with Audit and Compliance team to ensure that Global Medical Affairs audits are properly planned, communicated and that audit targets for MA audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within MA function. Improve/strengthen QA engagement with Global Oncology Medical Affairs, Specialty Medical affairs, through lessons learned, process improvement and ongoing collaborations.
Provide end to end process consultation impacting products from a quality perspective. Provide regular updates to management on Mid Term strategy (MTS) for MA QA area and propose improved objectives as necessary. Deliver risk mitigation strategies and process improvements to stakeholders via the QMS framework (i.e., Quality Management Review, Quality Review Board) across the global medical affairs organization (Oncology and SM) and relevant external stakeholders.
The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC and EU):in an efficient and effective manner including, but not limited to oversight of defined work products, coaching and mentoring of global team, performance management and driving/contributing to organizational effectiveness/efficiencies.
RESPONSIBILITIES
Customer FocusProvide Medical Affairs quality oversight of the Oncology and Specialty Medicine portfolios, in alignment with the business strategy Lead the DSG inspection management activities by ensuring continued submission, compliance and inspection preparedness for the respective MA inspections in alignment with regulatory and company strategy. Act as management representative for all key health authority inspections (US FDA, EU EMA, MHRA etc.,). Develop and maintain an effective working relationship with US FDA and other international bodies.Ensure adequate CAPAs are defined, implemented, and closed through providing guidance and facilitation of quality event resolutionProactively ensure that all functions consistently operate in a state of compliance.Facilitate the implementation of the quality strategy in close alignment with the MA (Oncology and Specialty) business strategy. Monitor and track implementation and break-down of the Quality Manual into an annual Quality Plan together with the supported MA teams, including the quality risk assessments and inspection readiness components for the designated programs.Ensure proactive representation of Quality professionals at strategic non-project team and at MA strategic discussions.Lead the Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators (KQIs). Collaborate with Global QA teams in US, Japan, APAC, Europe and Brazil to ensure relevant quality reports and or assigned by Head, Global Development and Medical Affairs QA delivered in a timely manner. Ensure that risks are duly identified, mitigated in collaboration with the business functions. Identify appropriate continuous improvement initiatives for quality and compliance related areas.May Deputize for the Head, Global Development and Medical Affairs QA at Leadership teams, as appropriate and as needed. Oversight:
Provide strategic direction pertinent to MA activities for internal QA team (global/ local), but also to:Global Project TeamsGOMA and Specialty MA Management teamsData Management/ Biostats Clinical Safety and PharmacovigilanceR&DVendors/ CROs/ third partiesHEOR/ RWEEpidemiology Legal and compliance Marketing/ commercialGMP QA/ Supply chain / Regulatory Affairs Leadership/ team management:Create a high performing team environment and a cohesive culture driven by values of integrity, respect, and a speak up cultureLead and hold others accountable to performance, talent, and development objectivesCreate an environment that fosters diversity of thoughts, inclusivity and one that adheres to the principals set forth in the organization (JOIN, GROW, THRIVE)Create an environment that thrives on innovation, proactive quality and is disciplined to efficiently execute against pre-defined deliverablesDrive employee engagement, mentoring, coaching and performance managementExhibit servant leadership while driving results.Collaborate with internal and external stakeholders Interact with senior MA/functional leadership teams to ensure Quality is consistently and proactively represented at program level and support proactive quality risk management process.Interact with the audit and compliance function for the development of the UAP pertinent to MA area. Partners with the respective cross functional groups, CROs, Affiliates in order to ensure high data quality and proactive detection and resolution of issues. External Engagement:Continuously review compliance metrics trends from regulators/ industry experts and align develop the MA road map to meet changing regulatory and business needs. Assure a closed loop of MA risks identified through audits, inspections, internal meetings, remediation and risk management in close collaboration with the organization's quality management system, to assure robust knowledge transfer and continuous process improvement.Drive effective relationship with alliance partners, legal and compliance, collaborators, Marketing, R&D, vendors, and other key company partners to ensure a culture of compliance at all levelsInfluence change to drive continuous process improvement with stakeholders Strategy:Contribute to shape the strategic direction of the global Development and Medical QA function based on the organization's mid-term plan and beyondEnsure adequate MA QA(Americas/Europe Brazil) resource are in place and contribute to create a long term strategy for global MA QA across regions and geographic areas.Contribute to create and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient and effective organization Support the global quality annual objectives . click apply for full job details
Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
SummaryThe Executive Director, Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists across various regions, offering guidance and support to each product safety team in critical areas such as individual case medical review, risk management, aggregate safety reports, and translational medical safety. This role requires the individual to bring the latest knowledge in these fields, ensuring high quality and efficiency. This role will be responsible for recruiting and developing the CoE team, refining or expanding its scope as the organization evolves in collaboration with other departments, and coordinating and prioritizing CoE resources for key programs.The role will also provide senior safety leadership and guidance on complex issues across the DS portfolio, including both compounds in clinical development and marketed products. The successful candidate will work in collaboration with sub-functions within CSPV and other departments across the company to ensure alignment. This senior role will involve close cooperation with other CSPV Leadership to develop strategy and harmonize processes that support the department's objectives.
ResponsibilitiesA member of DSI CSPV and Global Medical Safety leadership teamDevelop or leverage expertise to support the creation of strategies and objectives for DSI CSPV and Global Medical Safety, including the CoE, ensuring alignment with the broader DS goals and objectives.Collaborate with other leadership members to manage DSI CSPV HR-related matters, including performance reviews and departmental talent development.Line management and senior leadership accountabilities in CoELead a team of safety physicians and scientists by recruiting, developing, and retaining talent; coach, mentor, and influence team members within the CoE as well as other members of CSPV.Ensure sufficient resources for key programs; collaborate closely with team leads in other regions to coordinate resources and talent development.Ensure the full implementation of all CSPV strategic change initiatives within the CoE.Refine and expand the global roles and responsibilities of the CoE as the organization grows and business needs evolve.Ensure the CoE's continuous operational execution and excellence by applying best practices in accordance with regulatory requirements and guidelines worldwide, and in alignment with the CSPV governance and operating model.Provide medical and scientific guidance to teamsProvide oversight and guidance for all medical and scientific activities within the CoE group, including the global efforts of teams in other regions. May directly manage complex safety issues related to individual case review, risk management, translational medical safety, and aggregate safety reports, including: ensure that adverse events are evaluated accurately and promptly, including clinical assessments to determine the seriousness, causality, and expectedness of the adverse event in relation to the drug. Ensure all relevant data and findings are incorporated into comprehensive safety reports as required by all regulatory authorities.Ensure a robust risk management process with appropriate tools, serving as the expert in risk management for product safety teams.Prioritize areas for translational medical safety and make a meaningful impact on clinical development at the program level.Lead projects to enhance processes within CSPV, including the CoE, and/or to develop and implement new technologies and approaches at a global level.Maintain a high level of understanding and awareness of internal and external scientific and regulatory trends in these four areas, and communicate these insights to leadership and team members as appropriate.Establish networks with other teams/functions and external stakeholders to stay informed about new developments, leverage opportunities, and share best practices.Compliance responsibilitiesEnsure that all activities of the CoE group comply with Good Clinical and Pharmacovigilance Practices, as well as all relevant internal and external regulations and standards.
Basic Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)Must have a MD in relevant scientific discipline is required, a combination MD/PhD strongly preferredExperience Qualifications10 or more years of relevant pharmaceutical industry experience in clinical development or clinical safety/post marketing safety in the pharmaceutical industry requiredMust have at least 4 or more years of pharmaceutical industry expertise in clinical safety/post marketing safetyDemonstrated people management/leadership experience (at least 5 years leading direct reports)Proven experience leading safety physicians and scientists in individual case medical review, aggregate reporting, risk management, and/or translational researchMust have excellent communication, project management, writing and analytic skillsMust be organizational leader with ability to influence others and collaborate cross functionally.Must have in-depth understanding of the most recent technical and regulatory advancementsTravel Ability Must be able to travel both domestic and international up to 10%Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management, important safety topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework. This individual will use strong leadership and communication skills to ensure effective collaboration across development functions and sites. The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization).
Responsibilities
- Depending on the status of development of the compound, lead and medical-scientifically direct a team of junior physicians and scientists responsible for a compound/product safety, including project-specific training and coaching of team members and review of team output cross-functionally.
- Effectively represent the CSPV on the Global Product Team or specific sub-teams such as clinical study team and submission team, providing the safety leadership and serving as the primary point of contact.
- Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt identification of safety signals. Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy, expectedness and relatedness.
- Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.
- Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle.
- Effectively coordinate and manage available resources in developing and delivering high-quality safety evaluation related documents/deliverables on time.
- Coordinate and participate actively in safety-related regulatory interactions (e.g., regulatory meetings, post-approval commitments).Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- MD Board certification or eligibility requiredExperience Qualifications
- Must have 4+ years of professional clinical safety expertise from pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology.Expertise in Oncology highly preferred.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary:This position will lead the valuation processes for in-licensing, out-licensing, co-development and/or acquiring opportunities. Accountable to own the financial evaluation model developed in close collaboration with Global Business Development (US, Japan, EU teams), Finance (Corporate FP&A & R&D), Global Commercial & Strategy, Global Forecasting & Insights and Global Project Management. Successful execution will involve working cross-functionally to gather relevant information, synthesize the materials, and develop comprehensive opportunity assessments consistent with our corporate business development strategy. This position may lead a small team and will report to the Head of Forecasting/Business Analytics and Deal Valuations.
Responsibilities:
Cross-functional Collaboration: Collaborate with and lead cross functional teams (global/regional RD, IP, Legal, Finance, Forecasting, Manufacturing/Supply Chain, Commercial) to evaluate and execute on deal opportunities, including managing the interface with global/regional teams and ensuring alignment with project assumptions.Collaborate and set stage with the wider GBD team to formulate partnering strategy and objectives by providing insights and making recommendations with significant potential impact. Deal Valuation NPV Modeling Financial Support: Provide independent and high-quality financial support to all BDL transactions including In-Licensing, Out-licensing, Collaborations, and other strategic business initiatives.Develop valuation model, including sourcing and validation of key assumptions and data from global cross-functional teams (Marketing, RD, Finance, Supply Chain, etc). Deal Valuation Analysis: Lead analysis of financial analysis and models underpinning deal terms; analyze deal economics quickly to identify key value drivers and looks at key sensitivities. Preparation of financial aspects of business cases including valuation, PLs, cash flow analyses, sensitivity analyses, and other relevant financial metrics slides for presentation to governance committees.Orchestrate and drive detailed comparator deal analysis and run valuation scenarios to align proposed terms for new collaborations. Post Deal Support Analysis: Post deal support to DS Tokyo External Auditors, including asset Impairment Test analysis (explain deal structure, rationale and source of assumptions and key data supporting the deal valuation model)Qualifications:Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university) Bachelor's Degree Concentration in Finance/Business/Accounting is preferred requiredMBA Top tiered business school is highly preferredExperience Qualifications:10 or More Years Pharmaceutical/Biotech/Life Sciences/Investment Banking industries experience required2 to 4 or More Years BD&L transactions financial modeling preferredAbility to travel up to 20% Business meetings and/or conferences as required. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
