Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an Associate Director of Biostatistics to provide statistical expertise and operational support across a variety of clinical activities with a focus on supporting early-stage and late-stage clinical programs. This role will serve as lead study statistician, collaborating with cross-functional teams to support clinical development and data-driven decision-making. The Associate Director will contribute hands-on to key deliverables, manage CROs, and provide guidance to junior team members. Essential Responsibilities: Contribute to the statistical design and analysis of early and late phase clinical studies. Apply advanced statistical methods and data visualization skills to clinical trial data summaries and interpretations such as integrated safety and efficacy analyses for regulatory submissions. Serve as the biostatistics representative on cross-functional teams, ensuring alignment of statistical approaches with study and program objectives. Provide input on study design, endpoint selection, and sample size planning. Draft statistical analysis plans (SAPs) and support interpretation of results. Ensure the quality and accuracy of statistical deliverables by independently generating the statistical deliverables and/or independently reviewing and validating the statistical deliverables generated by either CRO or internal statistical programming team. Manage CROs and mentor junior staff or contractors as appropriate. The Ideal Candidate: Education: Ph.D. in Biostatistics with 6+ years of relevant industry experience, or Master's with 8+ years. Experience: Strong foundation in clinical trial design, statistical analysis, and regulatory guidelines. Experience in publication work and/or analysis of real-world data preferred. Proficiency in statistical programming (SAS and R). Immunology or related therapeutic area experience a plus. Demonstrated ability to manage multiple priorities and work cross-functionally. Experience with both early-stage and late-phase clinical trials in biotech/pharmaceutical industry is preferred. Skills: Strong analytical thinking and attention to detail. Excellent verbal and written communication skills. Ability to work independently in a fast-paced, regulated environment. Ability to manage deliverables with competing priorities and influence others effectively. Strong organizational skills, with the ability to manage workflows and activities to meet department timelines. Collaborative mindset and ability to influence without authority. The salary range for this position is $190,000 USD to $230,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices. This position is located in South San Francisco, CA, with an expectation to be onsite Tuesday through Thursday. While we prefer local candidates, remote applicants based in the Pacific Time Zone will be considered on a case-by-case basis. Alumis Inc. is an equal opportunity employer. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. Other benefits include: Health insurance premiums paid at 90% for employee, 80% for dependents Free access to Genentech Bus & Ferry Share program $100 monthly cell phone stipend Unlimited PTO for Exempt employees Free onsite gym and a kitchen stocked with yummy snacks and drinks! We are a hard-working, collaborative team on a mission to transform patient's lives and we aspire to elevate, challenge and nurture one another along the way.
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an experienced Principal Programmer, Statistical Programming (Contractor) to lead the development and validation of statistical programs for late-stage clinical studies. This role ensures programming activities are conducted in compliance with SOPs and regulatory requirements to produce high-quality, timely deliverables. Essential Responsibilities: Develop and validate statistical programs to generate high-quality, on-time deliverables for both in-house and outsourced projects, in compliance with company SOPs and regulatory requirements. Perform analysis tasks to support clinical study reports (CSRs) and integrated summaries of safety and efficacy (ISS/ISE) for NDA submissions. Create and review programming plans and specifications for datasets and TLFs; apply advanced knowledge of CDISC standards, including SDTM and ADaM, and experience in implementing these models. Review biometrics documents such as SAPs, CRFs, data review plans, and data transfer agreements. Conduct data quality checks across raw data, SDTM, and ADaM datasets; identify root causes of data issues and propose solutions. Review and validate CRO deliverables, including SDTM, ADaM and TLFs; provide solutions to issues raised by CROs. Review eSubmission datasets and associated documentation (e.g., aCRF, reviewer guides, define.xml, and programs) to ensure compliance with submission requirements. Leverage expert-level SAS programming skills to develop macros supporting study and project activities, enhancing programming efficiency and capacity. Maintain familiarity with ICH guidelines and demonstrate advanced knowledge of regulatory submission requirements and standards Support the preparation of clinical study reports, regulatory submissions, and DSURs and annual safety reports across multiple studies. Communicate effectively within project teams, across departments, with functional partners, and with external collaborators. Perform other programming duties as assigned.
The Ideal Candidate: Expert-level SAS programmer with a track record of delivering complex programming assignments; proficient in developing and modifying code, including macros. Advanced knowledge and hands-on experience with CDISC standards (CDASH, SDTM, and ADaM). Experienced in the drug development process and in collaborating with CROs. Familiarity with regulatory submission processes to FDA, EMEA, and CDE filings. Strong interpersonal skills and effective verbal and written communication capabilities. Highly detail-oriented with strong consistency and quality standards. Education: Bachelor's degree (or equivalent) in a computational or biological science with a minimum of 8 years of directly related experience in a drug development environment or Master's degree with a minimum of 6 years of related experience. This is a remote position based in South San Francisco, CA. While we prefer local candidates, remote applicants based across the continental United States will gladly be considered. Alumis Inc. is an equal opportunity employer. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. Other benefits include: Health insurance premiums paid at 90% for employee, 80% for dependents Free access to Genentech Bus & Ferry Share program $100 monthly cell phone stipend Unlimited PTO for Exempt employees Free onsite gym and a kitchen stocked with yummy snacks and drinks! We are a hard-working, collaborative team on a mission to transform patient's lives and we aspire to elevate, challenge and nurture one another along the way.
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. At Alumis, the Senior MSL/MSL is a strategic, field-based opportunity focused on developing and maintaining collaborative relationships with Dermatology and Rheumatology key external experts (KEEs) and other healthcare professionals (HCPs). The MSL will engage with HCPs to support trial enrollment, educate on disease states and clinical trial outcomes, and inform internal strategy by gathering insights and representing the voice of KEEs, HCPs, and payers. MSLs strive to optimize patient care through KEE engagement and collaboration. The MSL is a critical scientific expert working across the life-cycle of products with internal stakeholders to prepare and execute successful drug launches. Current geographical areas of need: New England Mid-Atlantic Southeast Southwest North Central Rockies/PacNW Responsibilities: Develop and maintain collaborative relationships with KEEs in the Dermatology and Rheumatology community. Utilize systems to strategically map, identify, profile and prioritize thought leaders in line with the medical plan and goals Effectively develop and manage your assigned geography with an entrepreneurial approach Support clinical development initiatives including site identification, trial recruitment, timely completion of study milestones, and presentation of data Attend and report on assigned medical conferences Collaborate with KEEs on medical affairs initiatives including publications, advisory boards, medical education opportunities, training, and speaker development Serve as scientific resource to external disease experts and internal stakeholders Support the medical community with up-to-date medical information, robust disease expertise, and product information Gather and communicate insights from HCPs to inform medical strategy Train internal stakeholders on key scientific and medical topics Maintain effective and appropriate communication among internal stakeholders while maintaining full compliance with relevant requirements Lead and/or contribute to Medical Affair workstreams, projects, or resource development Maintain accurate documentation of MSL activities Experience: Advanced degree in scientific, clinical, or medical-related discipline preferred. (PharmD, PhD, MSN, DNP, PA-C, MPH, etc). Dermatology or Rheumatology clinical experience is a plus. Experience in psoriasis and/or lupus a plus. At least 5 years of experience in MSL role, and must include support of clinical development studies Must have well-established networks and active relationships with KEEs in Dermatology and/or Rheumatology. Candidate must understand compliance considerations and demonstrate ability to work compliantly Ability and willingness to travel 60%. Required travel to medical meetings, team meetings, and other group meetings (will require some weekends). This may vary depending on business needs Skills, Knowledge & Abilities: Excellent oral and written communication skills Excellent interpersonal and engagement skills Energetically embraces responsibilities, demonstrates ability to achieve goals Demonstrates strong initiative as a flexible and proactive Ability to thrive in ambiguous situations Solution-oriented approach Exhibits excellent time management and ability to prioritize Demonstrated ability to work independently Experience in a start-up environment is a plus Unlike most roles at Alumis, this will be primarily remote and serving the North Central territory Level depends on experience. The salary range for this position is $220,000 USD to $230,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices. This position is primarily remote. Alumis Inc. is an equal opportunity employer. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. Other benefits include: Health insurance premiums paid at 90% for employee, 80% for dependents Free access to Genentech Bus & Ferry Share program $100 monthly cell phone stipend Unlimited PTO for Exempt employees Free onsite gym and a kitchen stocked with yummy snacks and drinks! We are a hard-working, collaborative team on a mission to transform patient's lives and we aspire to elevate, challenge and nurture one another along the way.
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis is hiring a Clinical Quality Assurance Sr. Director, reporting to the SVP of Quality. The role will work closely with the Development leadership and Study Execution Team members to provide GCP/GVP support for all ongoing clinical studies. This involves working closely with Clinical Operations, Clinical Development, Clinical Supply Chain, Medical Affairs, Regulatory, Legal, and other teams across Alumis. The Clinical QA Sr. Director is responsible to ensure quality is embedded throughout the lifecycle of all the ongoing clinical programs through oversight, assessment and monitoring, risk assessment tools and risk mitigations. The Sr. Director will be responsible to establish Key Performance Indicators and Metrics to trend and track the health of the clinical trials. The role is responsible for providing operational quality guidance for the development teams and supporting the VP of Quality in building the Alumis Quality organization strategy and vision. This position requires expertise in Good Clinical and Pharmacovigilance Practices (GCP & GVP) and relevant US and EU regulations. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and proactive quality management. The candidate will provide guidance and leadership to ensure that the quality function maintains the standards expected by global regulatory authorities.
Essential Duties & Responsibilties Establish and maintain the GCP QA programs, policies, and procedures. Ensure ongoing clinical programs are in compliance with applicable health authority regulations and guidelines. Act as the primary GCP QA subject matter expert and point of contact for all GCP/GVP related matters and issues. Establish the study-specific audit plan; perform audits and lead a team of external quality auditors as needed. Represent Quality on project teams, Health Authority Inspections, service providers and CROs operational meetings, and QA to QA meetings. Manage Quality Review Board meetings content and material. Prepare KPI and metrics. Provide quality oversight and review of key Clinical and IND/NDA enabling documents. Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations. Conduct root cause analysis for recurring issues. Determine the strategy for and lead the implementation of inspection readiness plans and activities. Act as the primary liaison with the Health Authority and internal/external business partners. Support clinical service provider selection and qualification activities and develop periodic compliance/metric reports.
Education & Experience Bachelors or advanced degree in Biology, Chemistry, or related field. Minimum 12 years of GCP/GVP Quality Assurance experience. Strong understanding of small molecule products with direct experience in solid oral dosage forms.
Knowledge Skills Abilities Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices. Hands-on experience in drug life cycle management. A successful track record of working with service providers and CROs. Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity. Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry. Excellent verbal and written communication skills. Collaborative, analytical and interpretative skills. Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others. Prior management experience is required. Previous experience in successfully leading assigned activities within cross-functional teams. Some travel is required. The salary range for this position is $260,000 USD to $275,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices. This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. At this time we are not considering remote applicants. Alumis Inc. is an equal opportunity employer. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. Other benefits include: Health insurance premiums paid at 90% for employee, 80% for dependents Free access to Genentech Bus & Ferry Share program $100 monthly cell phone stipend Unlimited PTO for Exempt employees Free onsite gym and a kitchen stocked with yummy snacks and drinks! We are a hard-working, collaborative team on a mission to transform patient's lives and we aspire to elevate, challenge and nurture one another along the way. Lab personnel are generally onsite 4-5 days/week.
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. The Director of Biostatistics will play a key role in providing statistical leadership across multiple Phase 2 and 3 clinical trials. As the statistical lead, you will develop and oversee statistical analysis plans, ensure the quality and accuracy of deliverables, and manage CRO partners to meet project timelines and standards. This role requires expertise in simulation work, multiple imputation analyses, and late-phase clinical development. As the Director of Biostatistics at Alumis, you will join a high-performing team of experienced drug developers dedicated to transforming outcomes for patients with autoimmune diseases. We are seeking someone with substantial filing knowledge and hands-on experience to play a critical role in the execution of the development of our lead compound. You will oversee the quality and accuracy of statistical analyses, and collaborate cross-functionally to develop integrated analyses for regulatory submissions. This role involves hands-on contributions to key statistical deliverables, such as analysis plans, clinical study reports, and data packages for regulatory submissions, while managing CROs and mentoring junior team members. Guided by our core values-We Elevate, We Challenge, We Nurture-you will play a pivotal role in advancing innovative therapies alongside a talented and experienced team. Essential Responsibilities: Apply advanced statistical methods to clinical trial data summaries and interpretations including integrated safety and efficacy analyses to support regulatory submissions. Provide statistical input for drug development plans, clinical study design, and operationalization. Perform as study statistician including the development or review of statistical analysis plans, clinical study reports, and presentations. Manage and oversee CROs. Ensure the quality and accuracy of study data and statistical outputs. Perform quality control checks on key efficacy and safety endpoints to validate data. Mentor junior staff and contractors, while primarily serving as an individual contributor. The Ideal Candidate: Education: Ph.D. in Biostatistics with at least 8 years of experience, or Master's with a minimum of 10 years of directly relevant experience in the biopharma industry. Experience: Strong expertise in statistical experimental design, clinical trial analysis, and regulatory requirements. Proven track record of planning, creating, and delivering Integrated Summaries of Safety and Effectiveness (ISS and ISE) and related reports for regulatory submissions. Proficiency with R and SAS software. Immunology experience preferred. Proven ability to manage deliverables with competing priorities. Skills: Excellent analytical thinking, attention to detail, and communication (written and oral). Demonstrated ability to work in a regulated environment and adhere to SOPs. Strong interpersonal skills and ability to influence cross-functional teams. Experience coaching and managing biostatistics staff is a plus. The salary range for this position is $245,000 USD to $255,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices. This position is located in South San Francisco, CA, with an expectation to be onsite Tuesday through Thursday. While we prefer local candidates, remote applicants based in the Pacific Time Zone will be considered on a case-by-case basis. Alumis Inc. is an equal opportunity employer. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. Other benefits include: Health insurance premiums paid at 90% for employee, 80% for dependents Free access to Genentech Bus & Ferry Share program $100 monthly cell phone stipend Unlimited PTO for Exempt employees Free onsite gym and a kitchen stocked with yummy snacks and drinks! We are a hard-working, collaborative team on a mission to transform patient's lives and we aspire to elevate, challenge and nurture one another along the way.
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis is hiring a Clinical Quality Assurance Director, reporting to the SVP, of Quality and Regulatory. The role will work closely with the Quality, Development, and Study Execution Teams to provide Clinical Quality support for all ongoing clinical studies. This involves working closely with Clinical Operations, Clinical Development, Clinical Supply Chain, Medical Affairs, Regulatory, Legal, and other teams across Alumis. The Clinical QA Director is responsible to ensure quality is embedded throughout the lifecycle of all the ongoing clinical programs through oversight, assessment and monitoring, risk assessment tools and risk mitigations. The Director will be responsible to establish Key Performance Indicators and Metrics to trend and track on the health of the clinical trials. The role is responsible to provide the operational quality support and guidance for the development teams and support the SVP of Quality and Regulatory in building the Alumis Quality organization strategy and vision. This position requires expertise in Good Clinical Practices and relevant US and EU regulations. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and proactive quality management. The candidate will provide guidance and leadership to ensure that the quality function maintains the standards expected by global regulatory authorities. ESSENTIAL DUTIES & RESPONSIBILITIES Establish, maintain and enhance GCP QA programs, policies, and procedures. Ensure ongoing clinical programs are in compliance with applicable health authority regulations and guidelines. Act as the primary GCP QA subject matter expert and point of contact for all GCP/CSV related matters and issues for the assigned program, project or study. Establish the study specific audit plan ensuring successful execution and audit findings close out including CAPA management and oversight. Establish and manage the Quality Risk Management program. Represent Quality on project teams, Health Authority Inspections, service providers and CROs operational meetings, and QA to QA meetings. Support Quality Review meetings content and material. Prepare and manage Quality KPI and metrics. Provide quality oversight and review of key Clinical and IND/NDA enabling documents. Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations. Conduct root cause analysis for recurring issues. Partner in implementation of inspection readiness plans and activities. Act as the primary liaison with Development and Compliance team in execution of inspection and audit readiness plans including for internal/external and business partners audits. Support clinical service provider selection and qualification activities and develop periodic compliance/metric reports.
EDUCATION & EXPERIENCE Bachelors or advanced degree in Biology, Chemistry, or related field. Minimum 10 years of Clinical Quality Assurance experience. Strong understanding of small molecule products with direct experience in solid oral dosage forms. KNOWLEDGE/ SKILLS/ ABILITIES Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices. Hands-on experience in drug life cycle management. A successful track record of working with service providers and CROs. Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity. Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry. Excellent verbal and written communication skills. Collaborative, analytical and interpretative skills. Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others. Prior management experience is required. Previous experience in successfully leading assigned activities within cross-functional teams. Some travel required. The salary range for this position is $190,000 USD to $240,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices. This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. Lab personnel, however, are generally onsite 4-5 days/week. At this time we are not considering remote applicants. Alumis Inc. is an equal opportunity employer. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. Other benefits include: Health insurance premiums paid at 90% for employee, 80% for dependents Free access to Genentech Bus & Ferry Share program $100 monthly cell phone stipend Unlimited PTO for Exempt employees Free onsite gym and a kitchen stocked with yummy snacks and drinks! We are a hard-working, collaborative team on a mission to transform patient's lives and we aspire to elevate, challenge and nurture one another along the way.
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an experienced and motivated Director, Commercial Program Management. In this highly visible, exciting role, you will partner with our Commercial Lead to guide the commercial team in alignment with the molecule development team and cross-functional team leads, providing exceptional program management for our lead molecule, currently in Phase 3. This position will report to the Head of Program and Portfolio Management (PPM). RESPONSIBILITIES Strategic thought partner to the Commercial Lead on launch readiness plans and activities for lead molecule, currently in Phase 3 Provide Project Management support by coordinating and aligning Launch Readiness Team, Commercial workstreams, and managing their activities. This includes meeting facilitation, tracking of action items and team deliverables, to execute on program's strategic plan and strategic objectives Provide Business Manager support including but not limited to driving annual business process execution (Ex. goals, budget, performance reviews), maintaining strong functional dynamics, acting as function lead or representative for enterprise-wide initiatives, and facilitating transparency and alignment with other functions and teams at Alumis Partner with other PMs (i.e. Project Team PM (PT PM) for lead molecule, CMC PM, Medical Affairs PM) to ensure seamless PPM support across lead molecule Ensure effective communication within commercial team and stakeholders to support good decision-making in fast-paced small company environment Proactively identify, analyze and communicate decision points and project risks, including tradeoff and scenario analyses (including timelines, costs, and risks), framing options within broader molecule context Act as a vendor liaison, providing contract, requisition processing, and invoice management support, as well as following up with vendor on project updates and status reports, to ensure timely and quality deliverables Identify needs and propose solutions to project and portfolio tools, systems and practices to support the growth and evolution of PPM's capabilities Support other business priorities as needed within PPM, including but not limited to potential assignments in research, development, clinical, medical affairs or CMC project management Manage others as needed THE IDEAL CANDIDATE Minimum 12 years industry experience, with at least 5 years of drug development project management (e.g. research, clinical, CMC, commercial, medical affairs), including commercial launch project management experience Highly skilled in communication, stakeholder management, and influencing without authority, where you are able to effectively interact with, and facilitate complex conversations across the organization Excellent critical thinking, verbal and written communication skills, with ability to simplify and integrate multiple cross-functional perspectives and inputs for team Agile and flexible: Able to step in, assess situations, and help team to make sound decisions in alignment with program strategy Strong organizational skills with critical attention to detail and ability to track to numerous deliverables Broad scientific and business acumen in the biotech or pharmaceutical industry, including a strong understanding of cross-functional dependencies Proficient with Microsoft Office Suite, as well as project management software such as MS Project and Smartsheets EDUCATION BA. or BSc. with MSc., MBA or Ph.D. a plus Project Management Professional (PMP) or other PM certification a plus The salary range for this position is $240,000 USD to $255,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices. This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. At this time we are not considering remote applicants. Alumis Inc. is an equal opportunity employer. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. Other benefits include: Health insurance premiums paid at 90% for employee, 80% for dependents Free access to Genentech Bus & Ferry Share program $100 monthly cell phone stipend Unlimited PTO for Exempt employees Free onsite gym and a kitchen stocked with yummy snacks and drinks! We are a hard-working, collaborative team on a mission to transform patient's lives and we aspire to elevate, challenge and nurture one another along the way. Lab personnel are generally onsite 4-5 days/week.
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking a talented and motivated leader to join our IT team as the Sr. Manager, IT, R&D Applications, supporting core business applications for corporate enterprise needs across Development and Research teams including QA, Clinical Operations, Biometrics, Medical Affairs, and Regulatory functions. This position may also assist in supporting initiatives on the enterprise and cross-departmental level. In this role, you will collaborate closely with stakeholders and manage implementation, maintenance, and ongoing support for the SaaS technologies used by these business functions to enhance efficiency and drive business outcomes. The ideal candidate has a solid technical background, is well organized, independent and possesses a "can-do" attitude. This role reports to the Director, R&D Business Partner. Duties & Responsibilities Lead and gather business requirements, processes, and drive implementation of change requests. Oversees the design, configuration, implementation, and maintenance of relevant R&D applications. Drive continuous improvement initiatives to optimize application performance and enhance user's experience. Collaborate with cross-functional teams to integrate applications with other enterprise systems. Lead the R&D application upgrades and implementations as the IT System owner. Manage and oversee user administration, workflow development, operational support, troubleshoot, and resolve R&D business application production issues. Ensure IT policies and procedures are communicated to all personnel and compliance is maintained. Establish/maintain relationship with internal stakeholders, technology teams and external technology vendors. Prepare and deliver presentations to key stakeholders. Qualifications Bachelor's degree in Computer Information Systems, Business Administration or related discipline. 8+ years of industry experience in commercial Biotech, Pharma or Life Sciences Company. Knowledge of Drug Development process and sub-process within each department, with an emphasis on Biometrics, QA, and Clinical Operations. Experience developing relationships with and ensuring the appropriate participation of key stakeholders and internal customers. Extensive knowledge of Cloud Systems in a Life Sciences Environment. Experience with implementing, integrating, and managing R&D software solutions such as Veeva Vault (QualityDocs, LMS, Promomats, Medical CRM), SAS, DocuSign Part 11, PhelxGlobal eTMF. Strong working knowledge of System Development Life Cycle methodologies in project delivery. Extensive knowledge of Regulatory requirements and standards (FDA 21CFR Part 11) Exceptional vendor management skills. Superior organization, planning, and project management skills. Ability to work in a small, fast-paced IT team. Ability to distill technical concepts and present to a non-technical audience. Accuracy and responsibility, ability to work with minimal supervision. Excellent customer service skills and ability to demonstrate a passion to assist and add value to department and company. Excellent analytical, troubleshooting, and decision-making skills. Proven ability to perform effectively under conditions such as project changes, tight deadlines, limited resources. The salary range for this position is $185,000 USD to $200,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices. This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. At this time we are not considering remote applicants. Alumis Inc. is an equal opportunity employer. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. Other benefits include: Health insurance premiums paid at 90% for employee, 80% for dependents Free access to Genentech Bus & Ferry Share program $100 monthly cell phone stipend Unlimited PTO for Exempt employees Free onsite gym and a kitchen stocked with yummy snacks and drinks! We are a hard-working, collaborative team on a mission to transform patient's lives and we aspire to elevate, challenge and nurture one another along the way. Lab personnel are generally onsite 4-5 days/week.
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. The Senior Director of Clinical Operations is a pivotal role within our organization, responsible for driving the management, oversight, and hands-on execution of Alumis's clinical programs. Serving as both a strategist and implementer, this dynamic leader ensures projects are completed on time, within budget, and meet all regulatory and corporate quality standards. As a key functional leader and subject matter expert, you will collaborate with other functional leads to achieve departmental and corporate objectives. As a champion of Alumis's core values, you will challenge existing processes and nurture a supportive environment where team members can show up authentically and speak openly. Leveraging your extensive industry knowledge and experience, you will proactively enhance the efficiency, effectiveness, and quality of Alumis's clinical trial activities. Reporting directly to the Senior Vice President of Development Operations, you will embrace a commitment to following the science and taking bold, thoughtful risks to find innovative solutions to challenging technical and business problems. Essential Responsibilities: Manage and implement clinical operational functions, allocating and directing internal resources and effectively outsourcing when necessary to achieve project goals in a timely manner. Strategically plan and execute clinical trials, ensuring they are conducted within timelines, budget, and regulatory and corporate quality standards. Actively lead and participate in the development of critical study documents, such as protocols, ICFs, study plans/manuals, investigator brochures, and clinical study reports. Lead constructive interactions with clinical sites to ensure that all trials and programs have clearly defined plans, strategies, and milestones. Identify outsourcing needs and oversee the selection, management, and performance of CROs, vendors, and external consultants. Be accountable for budgeting, forecasting, and overall management of clinical budgets. Develop and maintain strong, positive collaborations with internal and external functional leaders. Promote a strong quality culture within Clinical Operations, ensuring clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/policies, and industry best practices. Lead responses to audits as required, including site, internal file and process, and regulatory agency audits. Develop and execute resourcing plans to ensure adequate and appropriate monitoring of all trials. Provide accurate, current updates to executive management related to the status of clinical trials (e.g., monthly or as needed). The Ideal Candidate: Professional Experience / Qualifications: Extensive experience in setting up and managing domestic and international early and late-phase clinical trials, either directly or through CRO/vendor management. Proven ability to manage multiple projects and priorities. Strong working knowledge of GCP/ICH guidelines. Experience in developing and managing departmental and study budgets and timelines. Excellent interpersonal skills with a demonstrated ability to effectively work with internal and external cross-functional groups. Extensive knowledge of drug development functions relevant to clinical trial conduct (e.g., data management, biostatistics, pharmacovigilance, CMC/supply chain management, etc.). Demonstrated ability to collaborate effectively in cross-functional teams, to lead and develop a high-performing team and to mentor team members at all levels. Excellent written, communication, and interpersonal skills, with demonstrated cultural agility. Embody and champion Alumis Biotech's values: to nurture, to elevate, and to challenge. Education: A bachelor's degree or higher in a relevant field, preferably related to biological or life science. Higher/professional degree a plus. Preferred Experience: At least 15 years of Clinical Operations experience, including 10+ years in a management role and 5+ years in the field of autoimmune disease. The salary range for this position is $235,000 USD to $280,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices. This position is located in South San Francisco, CA, with an expectation to be onsite Tuesday through Thursday. At this time we are not considering remote applicants. Alumis Inc. is an equal opportunity employer. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. Other benefits include: Health insurance premiums paid at 90% for employee, 80% for dependents Free access to Genentech Bus & Ferry Share program $100 monthly cell phone stipend Unlimited PTO for Exempt employees Free onsite gym and a kitchen stocked with yummy snacks and drinks! We are a hard-working, collaborative team on a mission to transform patient's lives and we aspire to elevate, challenge and nurture one another along the way.
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. The Associate Director, Data Management (AD, DM) is responsible for ensuring high-quality management of clinical trial data in a rapidly evolving environment, in accordance with industry standards. This role oversees the execution of data management (DM) activities and deliverables across multiple studies, leading key initiatives such as Case Report Form (CRF) design, clinical database development, creation of Data Management Plans, external data transfer agreements, and CRF completion guidelines. Additionally, the AD, DM will ensure the implementation of programmed edit checks and data quality listings, track clean patient data, and oversee database closure. This position reports to the Senior Director, Data Management or a higher-level leader. Responsibilities Serve as the DM Study Lead for one or more clinical trials. May provide line management for DM support roles. Represent Clinical Data Management (CDM) in cross-functional meetings. Ensure timely completion of DM project deliverables while maintaining quality standards and regulatory compliance from study start-up through study closure and archival. Establish and maintain strategic business relationships with CDM vendors; apply effective vendor management practices throughout the study. Ensure complete and accurate CDM documentation, including eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and Data Management Plans. Perform thorough development testing of eCRFs prior to deployment, including creating User Acceptance Test (UAT) Plans, Test Scripts, and executing testing as applicable. Ensure accurate development and execution of data integrations between EDC, IXRS, and/or external vendor data sources. Manage the setup and execution of data transfers for assigned studies, including the review of test data transfers for consistency with data transfer agreements. Participate in the Request for Proposal (RFP) process, including evaluating potential vendors. Review and contribute to study documents such as clinical study protocols, statistical analysis plans, and Mock Tables, Figures, and Listings (TFL) shells. Perform supplemental data reviews in alignment with data validation specifications and the Clinical Data Review Plan (CDRP). Participate in the review of blinded TFL outputs prior to final database locks. Report query trends and data/query/SDV metrics to the Study Execution Team (SET). Contribute to the development of EDC custom report specifications, SAS Clinical Programming report specifications, and associated outputs as needed. Prioritize projects and coordinate data management activities in support of corporate goals and objectives. Ensure DM project documentation is inspection-ready at all times. Lead or contribute to initiatives focused on DM process improvement, data quality assurance, and efficiency. The Ideal Candidate 10+ years of relevant experience with a Bachelor's degree or equivalent; MS or MBA preferred. Experience managing Phase I-IV clinical trials, both in-house and through CRO partnerships. Strong knowledge and experience with Electronic Data Capture (EDC) and other key technologies such as IXRS and data visualization tools. Proficiency in CDISC standards (CDASH, SDTM, ADaM). Experience with SAS, SQL, and/or other clinical programming tools. Strong understanding of clinical research regulations and guidelines, including FDA CFR and ICH GCP. Broad experience across all aspects of data management, including CRF and database development, data quality assurance and analytics, data transfer management, vendor oversight, study documentation, and inspection readiness. Strong knowledge of MedDRA and WHO Drug coding classification systems. Excellent interpersonal, organizational, and communication skills (oral and written). Proven ability to build strong relationships with internal and external stakeholders. Logical thinker with strong attention to detail, accuracy, and problem-solving abilities. Ability to prioritize tasks and adapt quickly to changing business conditions with a proactive, solutions-oriented approach. Willingness to travel as required. Education Bachelor's degree or equivalent in a relevant field, with a minimum of 10 years of experience in clinical data management. Master's degree (MS or MBA) is a plus. The salary range for this position is $195,000 USD to $220,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices. This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. At this time we are not considering remote applicants. Alumis Inc. is an equal opportunity employer. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. Other benefits include: Health insurance premiums paid at 90% for employee, 80% for dependents Free access to Genentech Bus & Ferry Share program $100 monthly cell phone stipend Unlimited PTO for Exempt employees Free onsite gym and a kitchen stocked with yummy snacks and drinks! We are a hard-working, collaborative team on a mission to transform patient's lives and we aspire to elevate, challenge and nurture one another along the way.
