Associate Director of Process Chemistry

About Us Kardigan is a pioneering heart health company dedicated to transforming cardiovascular disease into a preventable, treatable condition, aiming to eliminate it as the leading cause of death globally.Our mission is to develop a diverse range of targeted treatments concurrently that will lead to the cures our patients with cardiovascular diseases deser…

At Alumis Inc., we are passionate about revolutionizing the treatment landscape for individuals suffering from autoimmune diseases. Our commitment to precision medicine drives us to innovate treatments that significantly enhance patient outcomes, addressing the unmet needs of those living with immunologic conditions.We are currently in search of an experienced Associate Director of Biostatistics to lend their statistical acumen and operational support to both early-stage and late-stage clinical programs. This pivotal role will see you acting as the lead statistician for various studies, collaborating with multidisciplinary teams to facilitate clinical development and informed decision-making through data analysis. You will play an active role in critical deliverables, oversee CRO activities, and mentor junior team members, fostering a culture of excellence within our statistical team.

The PositionAs the Director of Biostatistics at Maze Therapeutics, you will be pivotal in guiding the clinical advancement of our innovative therapeutic programs. This role involves close collaboration with teams in Clinical Science, Regulatory Affairs, Clinical Pharmacology, Development Science, and Translational Science, ensuring our clinical studies are methodologically sound, data-driven, and impactful.You will be responsible for the biostatistical strategy and execution, overseeing the entire process from study design to regulatory submissions, seamlessly blending hands-on expertise with strategic oversight. Your role will include representing the Biostatistics function in clinical study teams, guiding the interpretation of intricate data, and managing CRO partnerships to guarantee the delivery of high-quality statistical outputs.This position reports directly to the Vice President of Biometrics.Your ImpactLead biostatistical efforts for clinical studies, offering expert insights on study design, endpoints, and statistical methodologies.Oversee the completion of all technical and operational statistical tasks for a portfolio of clinical trials, ensuring the development and review of complex and innovative statistical analysis plans (SAPs).Work collaboratively with cross-functional teams on protocol development, study design discussions, and data interpretation.Partner with Statistical Programming to develop and validate analyses for internal purposes, publications, and regulatory submissions.Supervise CRO execution of statistical tasks, ensuring adherence to timelines, quality standards, and analytical approaches.Represent the Biostatistics department in regulatory interactions (FDA, EMA, PMDA, etc.), contributing to briefing documents, meeting preparations, and responses to agency inquiries.Contribute to clinical study reports (CSRs), integrated summaries (ISS/ISE), and regulatory submissions (NDA/BLA/MAA).Utilize advanced statistical techniques to analyze and interpret clinical, safety, biomarker, and exploratory data.Advise internal and external stakeholders on statistical methodologies, data integrity, model selection, and result interpretation.Lead the integration and analysis of diverse data sources to facilitate the delivery of special projects and statistical analysis plans for assigned products.Review and assess safety reports, biomarker analyses, and other elements of clinical trial monitoring.Enhance statistical software as needed by programming new techniques; stay updated on current and emerging trends in statistical analysis methodologies and tools.Provide biostatistical input into clinical development documentation and scientific publications.

About the RoleAs the Director of Statistics at AbbVie, you will lead a talented team of statisticians in designing and analyzing clinical trials, ensuring the highest standards of statistical rigor. You will collaborate with cross-functional teams to drive innovative solutions that impact patient outcomes.Key ResponsibilitiesOversee statistical methodology development and implementation for clinical research.Guide statistical analysis plans and ensure compliance with regulatory standards.Mentor and develop junior statisticians and promote a collaborative environment.

Join AbbVie as an Associate Director of Innovation, where you will play a crucial role in driving the future of our research and development initiatives. This dynamic position allows you to collaborate with cross-functional teams to identify and implement innovative solutions that enhance our product offerings.

Calico Labs is hiring an Associate Director of External Communications based in South San Francisco, CA. This leadership role focuses on shaping and executing external communication strategies to strengthen the company’s public profile. Role overview The Associate Director will oversee how Calico Labs communicates its mission, research, and advancements to the public. The position involves working closely with teams across the organization to craft clear, compelling narratives that highlight the company’s work in biotechnology. What you will do Lead the development and execution of external communication strategies Enhance brand visibility through effective storytelling and media outreach Manage media relations to ensure accurate and broad coverage of company initiatives Collaborate with cross-functional teams to align messaging Build partnerships and engage with key stakeholders Requirements Proven experience in public relations and strategic communication Strong background in managing media relations Ability to develop and deliver clear, engaging narratives Experience collaborating with multiple teams This position offers the chance to play a central role in how Calico Labs shares its vision and progress with the world.

Join AbbVie as an Associate Director of AI Transformation, where you will play a pivotal role in driving our AI initiatives to enhance patient outcomes and operational efficiency. This leadership position requires a blend of strategic vision and technical expertise, ensuring our AI solutions align with our organizational goals.In this role, you will lead a cross-functional team, collaborate with stakeholders, and leverage cutting-edge AI technologies. Your contributions will directly impact our commitment to innovation and excellence in healthcare.

Role overview Calico Labs is hiring a Director or Associate Director of Toxicology to lead research into the safety profiles of compounds under development. This leadership role shapes the approach to evaluating toxicological effects and plays a key part in decisions that guide the direction of health research at Calico Labs. Key responsibilities Direct research initiatives to assess the toxicological impacts of compounds in the development pipeline Guide safety and efficacy evaluations at each stage of the development process Work closely with scientific teams to inform study design and interpret results Apply toxicology expertise to advance Calico Labs' mission in health innovation Location This position is based in South San Francisco, CA.

Join AbbVie as an Associate Director in our R&D Information Research IT team, where you will play a pivotal role in driving innovation and supporting our research initiatives. In this hybrid position, you will collaborate with cross-functional teams to enhance our information systems and contribute to the advancement of groundbreaking therapies.

Calico Labs seeks an Associate Director or Director of In Vivo Physiology to join its team in South San Francisco, CA. This leadership role centers on research aimed at understanding and addressing diseases linked to aging. Role overview The Associate Director or Director will shape the scientific direction for in vivo physiology studies. This position supports Calico’s mission to advance health through research focused on age-related conditions. Key responsibilities Guide research projects that investigate the biology of aging and related diseases Direct scientific strategy and help set priorities for the in vivo physiology group Support Calico’s broader goals by fostering collaboration and scientific excellence Location This position is based in South San Francisco, CA.

The OpportunityAt the forefront of transforming drug discovery, insitro leverages the powerful intersection of multi-modal data and AI to redefine the development of medicines for complex diseases. Our mission is propelled by our capacity to attract, nurture, inspire, and retain a diverse array of exceptional talent, all while fostering a collaborative, high-performing, inclusive, and equitable culture.We are seeking an (Associate) Director, People Partner who will play a pivotal role in actualizing our people vision and strategy, setting a new benchmark for employee experience within the industry. In this influential position, you will provide coaching and support to leaders, managers, and team members across various situations, including employee relations, organizational design, and talent development.This role reports directly to the Chief People Officer and serves as a vital member of the leadership team. The position is based in South San Francisco, requiring onsite presence most days, with the flexibility to work remotely up to two days a week.ResponsibilitiesStrategic Partnership & Organizational EffectivenessAdvise executives on aligning manager and employee capabilities with mid-to-long-term business objectives.Collaborate with leaders across the organization to translate business strategies into people-centric initiatives that drive progress.Assist senior management in developing sustainable people and organizational strategies, programs, and practices that reflect our mission and goals.Identify and analyze root causes of workplace issues, team dynamics, and organizational inefficiencies.Talent Development & CoachingProvide coaching and guidance to leaders to enhance their managerial effectiveness in leadership team dynamics, organizational planning, change management, and talent management.Act as a trusted partner to managers and team members, proactively addressing obstacles that hinder optimal performance.Introduce best practices and innovative solutions for talent management, organizational design, retention, and engagement.People Operations & ComplianceCollaborate closely with the Legal team on employee relations matters.

Join AbbVie as a Scientific Director / Medical Director in the field of Medical Affairs focusing on Oncology, specifically targeting Ovarian Solid Tumor. In this pivotal role, you will lead strategic initiatives and research efforts aimed at improving patient outcomes through innovative therapies. Collaborate with cross-functional teams to develop and implement comprehensive medical strategies that align with our commitment to advancing oncology care.

Join AbbVie as the Director of AI Transformation, where you will lead the charge in harnessing artificial intelligence to drive innovation and improve patient outcomes. You will be responsible for developing and implementing cutting-edge AI strategies that align with our mission to enhance the quality of life for patients around the globe. Collaborate with cross-functional teams to integrate AI technologies into our existing processes and workflows, ensuring that we stay at the forefront of healthcare advancements.

Cellares is on the lookout for a visionary and dynamic Director of Facilities Engineering to play a pivotal role in driving our mission to enhance access to transformative cell therapies.In this critical position, you will oversee the management, operations, and maintenance of our facilities and crucial support systems, ensuring adherence to GMP, quality, and Environmental Health and Safety (EHS) standards. Your responsibilities will include managing office spaces, cGMP cleanroom suites, QC laboratories, warehouses, utility systems (gases, HVAC, lab equipment), and all equipment integral to our cell therapy operations. Additionally, you will lead our maintenance and calibration programs, cleaning initiatives, and capital expansion projects (CAPEX), which involve facility buildouts.The ideal candidate will have a robust background in facilities leadership, particularly within cGMP operations in the biotech or pharmaceutical sectors. You will be instrumental in providing strategic vision and leadership to ensure the reliability of our facilities, compliance with state and federal regulations, and the continuous improvement of processes that propel our business growth.This position is multidisciplinary, requiring collaboration across various departments, including scientists, researchers, and engineers, to devise optimal solutions. We are looking for a proactive and self-sufficient individual who thrives in a fast-paced, mission-driven environment and is ready to embrace a diverse range of challenges as our company expands.

As the Commissary Director at Proper Food, you will collaborate closely with our Executive Chef to oversee the operations of our central commissary kitchen located in South San Francisco. This role involves full accountability for the seamless and efficient preparation and packaging of food within a commissary kitchen setting. You will lead a substantial team of over 90 employees, fostering a strong, fair, and composed work environment.If you are a seasoned chef with outstanding leadership skills, a commitment to quality and consistency, and are excited about steering a rapidly growing concept, we encourage you to apply for this position.What We Provide:Attractive compensation package, including base salary and performance bonusesAnnual salary range of $100,000 - $110,000Comprehensive medical, dental, and vision coverageAn opportunity to play a pivotal role in the growth of an innovative concept, along with personal development.Key Responsibilities of the Commissary Director:Leadership: Take charge of the entire operation, ensuring the team maintains high morale while upholding Proper Food's values. You will be responsible for meeting labor, COGS, and productivity targets each month.Employee Management: Recruit, train, schedule, and supervise kitchen staff to ensure consistent quality and adherence to labor cost goals. Handle HR duties including monitoring employee attendance and managing PTO documentation. Cultivate an environment of transparent communication, consistency, and teamwork.Food Safety and Quality: Guarantee that all food is of exceptional quality, beautifully presented, and prepared according to HACCP guidelines. Ensure compliance with all food handling and sanitation regulations.Inventory Management: Oversee ordering, inventory control, and usage to meet cost objectives and enhance commissary efficiency.Analytical Support: Document and calculate food costs and nutritional information. Keep digital files organized for recipes and operational procedures.

Lead and strategize all CMC regulatory initiatives to ensure adherence to global regulatory standards for the development of ORIC's innovative products.Deliver CMC regulatory support for both new and ongoing clinical trials, including the management and preparation of CMC documentation for INDs, CTAs, and amendments submitted to global regulatory agencies (RAs) and health authorities (HAs).Collaborate effectively with teams in Pharmaceutical Development, Drug Substance, GMP Quality Assurance, Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.Oversee the preparation and responses for CMC-related meetings with global RAs and HAs, aligning regulatory obligations with corporate goals.Stay updated with global CMC regulations and proactively identify and assess regulatory risks, formulating mitigation strategies.Plan, supervise, and manage all CMC components of regulatory submissions, including strategies for updating existing dossiers and submitting new INDs, CTAs, NDAs, MAAs, and more.Assess proposed manufacturing modifications for their global impact on existing filings and provide strategic regulatory guidance for effective implementation.Offer hands-on assistance in generating CMC documentation (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.).

About Us:Calico Life Sciences LLC, a forward-thinking research and development company established by Alphabet, is dedicated to unraveling the complexities of human aging through innovative technologies and model systems. Our mission is to deepen understanding of the biology underlying aging, enabling us to create interventions that promote longer, healthier lives. Our state-of-the-art laboratories, commitment to groundbreaking discovery science, and robust pipeline of drug development in collaboration with academic and industry partners, make Calico an inspiring environment for driving medical advancements.Role Overview:We are on the lookout for a dynamic and experienced Director of Research to oversee our early discovery research team comprising talented Principal Investigators and their lab teams. This pivotal role will involve shaping research strategies, assessing research outcomes, and propelling our early-stage drug discovery initiatives aimed at enhancing healthspan through the development of new therapies for aging and age-related conditions. We are particularly interested in candidates with expertise in advanced biochemical, molecular, and cellular biological methodologies, including but not limited to microscopy and omics technologies, to dissect the intricacies of aging biology. A strong background in transitioning projects from early discovery to translational drug development is essential.Join our collaborative and cross-disciplinary team at the forefront of aging research, partner with world-class technology laboratories, spearhead ambitious research initiatives that redefine our understanding of aging, and innovate therapeutics for aging and age-associated diseases.

Oric Pharmaceuticals is hiring a Director of IT Enterprise Applications to lead the company’s approach to enterprise software. This role sits within the Information Technology team and plays a key part in shaping how technology supports daily business operations. Key responsibilities Develop and carry out strategies for enterprise application systems. Oversee projects that implement new software in support of company-wide objectives. Collaborate with teams across departments to ensure technology solutions fit business needs. Promote both innovation and efficiency through the use of enterprise applications. Location This position is based in South San Francisco.

Join Oric Pharmaceuticals as the Director of CMC Development for Rinzimetostat, where you will lead a dynamic team focused on advancing our innovative therapies. In this pivotal role, you will oversee the development and manufacturing processes, ensuring the successful delivery of our products from concept to market.