Director of IT Enterprise Applications

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 d…

Join AbbVie as the Director of Statistics, where you will lead a dynamic team dedicated to advancing our research and development efforts. In this pivotal role, you will oversee statistical methodologies and drive innovative solutions to support our clinical trials and product development processes. Your expertise will be vital in shaping data analysis strategies and ensuring the integrity of our statistical outputs.

Join Kardigan as a Senior Manager of Statistical Programming, where you will lead a dynamic team of statistical programmers to deliver innovative data solutions in clinical research. You will be responsible for overseeing programming activities, ensuring compliance with regulatory standards, and providing mentorship to junior staff.In this role, you will work closely with cross-functional teams to interpret complex data and translate it into actionable insights. Your expertise will drive the development of statistical analysis plans and programming specifications, contributing to the advancement of groundbreaking therapies.

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.

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 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.

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.

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.

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 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.

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.

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 deserve. Founded by industry leaders Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s founders have reunited following their success at MyoKardia, where they facilitated the discovery and development of mavacamten, the first cardiac myosin inhibitor, culminating in the acquisition by Bristol Myers Squibb in 2020. We boast a cutting-edge discovery and translational research platform, a pipeline full of late-stage candidates, and an exceptional team devoted to enhancing patient lives. At Kardigan, our values drive our work, interactions, and achievements. We are patient-centered, fiercely committed to improving lives and prioritizing patient needs. We believe in authenticity, fostering an environment of acceptance through honest leadership. With a curiosity-driven mindset, we encourage innovative thinking and adaptability. We strive for team success, supporting one another in our collective mission with urgency and excellence. Finally, we aim to enable the impossible, taking calculated risks to inspire innovation and advance scientific breakthroughs. Our core values empower us daily to make a significant impact. Position Title: Associate Director (AD), BiostatisticsDepartment: Development - Data ScienceReports To: Director, BiostatisticsLocation: South San Francisco, CA or Princeton, NJ

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.

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.

As the Director of Discovery AI Partnerships at AbbVie, you will be at the forefront of innovative collaborations that leverage artificial intelligence to enhance our drug discovery processes. You will lead strategic initiatives, build and maintain relationships with key partners, and drive the integration of AI technologies into our research frameworks. This leadership role requires a visionary mindset, strong project management skills, and the ability to navigate complex scientific challenges.

About Us: Calico Life Sciences LLC, a pioneering research and development entity backed by Alphabet, is dedicated to advancing the understanding of human aging through innovative technologies and modeling systems. Our mission is to leverage this knowledge to develop interventions that enhance health span, enabling individuals to live longer, healthier lives. With a commitment to curiosity-driven scientific discovery and collaborative partnerships in drug development, Calico offers an inspiring environment to foster significant medical breakthroughs. Position Overview: As a Medical Director/Senior Medical Director at Calico, you will report directly to the Head of Clinical Sciences. Your primary focus will be on providing strategic insights into the translational and clinical development of projects aimed at enhancing human health span through a better understanding of aging and age-related diseases, with a specific emphasis on neurologic and neuropsychiatric conditions. Key Responsibilities: Lead cross-functional teams to translate preclinical mechanistic data to clinical applications and develop translational biomarkers for innovative targets in neurologic and neuropsychiatric fields. Collaborate with research and drug development leaders both within and outside Calico to refine disease indication strategies for new targets. Utilize clinical expertise to guide the creation and application of preclinical models in partnership with discovery and biomarker scientists. Work closely with various drug development teams to shape new clinical programs throughout their lifecycle, particularly focusing on translational and early clinical development phases (Phase 0 through Phase 2). Design and implement experimental medicine studies to validate the mechanism of action for novel targets in neuropsychiatric disorders. Formulate and execute early clinical development strategies to establish proof of concept across various neuropsychiatric indications. Contribute scientific and medical knowledge for protocols, Investigator Brochures, Clinical Study reports, regulatory submissions, and other vital documents.

About UsKardigan is a pioneering company focused on heart health, striving to make cardiovascular disease both preventable and curable. Our mission is to develop a variety of targeted treatments in parallel to ensure individuals suffering from cardiovascular diseases receive the cures they deserve.Founded by industry leaders Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan builds upon their experience from MyoKardia, where they were instrumental in the discovery and development of mavacamten, the first cardiac myosin inhibitor, which led to its acquisition by Bristol Myers Squibb in 2020. Our organization boasts a state-of-the-art discovery and translational research platform, a robust pipeline of late-stage candidates, and a dedicated team committed to enhancing patient outcomes. At Kardigan, our core values shape our work culture, guiding our interactions and helping us achieve our goals. We are driven by a commitment to patients and their families, ensuring their needs remain our highest priority. We value authenticity, foster an environment of acceptance, and encourage a culture of curiosity and continuous learning. Teamwork is at the forefront of our mission, as we support each other in our collective pursuit of excellence. We embrace innovation and are unafraid to take calculated risks to advance scientific breakthroughs. These values empower us to make a tangible impact every day. Job OverviewKardigan is in search of a Director of External Manufacturing to oversee the development of a comprehensive late-phase portfolio. This position will report directly to the Senior Director of External Manufacturing.