Clinical Pharmacology Lead
14 hours ago
Zentalis Pharmaceuticals is seeking a highly experienced Clinical Pharmacology Lead to join our team. As a key member of our clinical development team, you will be responsible for providing clinical pharmacology, translational, and quantitative clinical pharmacology expertise to support the development of our pipeline.
Key Responsibilities- Design and implement clinical pharmacology plans using traditional and model-informed drug development approaches.
- Evaluate and perform hands-on analysis of clinical PK/PD data, authorizing PK clinical study reports.
- Support the development and execution of the quantitative clinical pharmacology strategy for nonclinical and clinical development teams.
- Ensure appropriate planning and execution of data modeling/pharmacometrics activities in support of projects and perform advanced quantitative pharmacology and pharmacometrics analyses.
- Manage external vendors to ensure high-quality M&S deliverables and adherence to planned timelines/budgets.
- Maintain a current understanding of PK and PD literature and methodology, as well as the scientific literature related to our specific drug discovery projects.
- Contribute to clinical development/clinical pharmacology strategy and planning for clinical programs.
- Ensure timely and accurate communication of study results and interpretation to internal drug development teams.
- Provide PK/PD modeling to support dosing strategies for clinical programs.
- Write and edit dose rationale sections of clinical protocols and investigator brochures, INDs, CTAs, and NDAs.
- Prepare Clinical Pharmacology components of regulatory submissions and represent the Clinical Pharmacology line at meetings with regulatory agencies and health authorities.
- Ensure appropriate quality of documentation for internal department studies compatible with global regulatory submission requirements.
- PhD, MD, or PharmD with relevant expertise in pharmacokinetics, pharmacology, or pharmaceutical science.
- Minimum of 10-12 years of direct industry experience in conducting clinical-stage drug development.
- Expert-level skills and expertise in modeling and simulation activities (NCA, population PK/PD modeling, literature meta-analyses, exposure-response analyses).
- Expert knowledge and hands-on experience in NONMEM or Monolix, R, and/or SAS.
- Additional experience with Stan, Phoenix/nlme, SAS, Python, Julia, or other mixed-effects software is preferred.
- Experienced in developing clinical pharmacology plans and in the preparation of regulatory submissions (including INDs, NDAs, BLAs, and/or significant sNDAs/sBLAs).
- Experienced in responding to regulatory questions related to all aspects of clinical pharmacology.
- Knowledge, skills, and abilities in the application of current practices in the areas of clinical pharmacology, pharmacokinetics, oncology, drug metabolism, bioanalysis, biopharmaceutics, regulatory affairs, and toxicology.
- Population PK/PD analysis and PBPK modeling experience.
- Experience in working with external CROs with timely delivery of clear and accurate well-written study findings.
- Strong knowledge of clinical drug development and FDA and ICH guidance documents is essential.
- Excellent oral, written, and presentation skills with the ability to stay organized across multiple projects.
-
Clinical Pharmacology Lead
3 weeks ago
San Diego, California, United States Zentalis Full timeJob SummaryZentalis is seeking a highly experienced Clinical Pharmacology Lead to join our team. As a key member of our clinical development team, you will be responsible for providing clinical pharmacology expertise to support the development of our pipeline.Key ResponsibilitiesDesign and implement clinical pharmacology plans using traditional and...
-
Senior Director, Clinical Pharmacology Lead
3 hours ago
San Diego, California, United States Crinetics Pharmaceuticals Full timeSenior Director, Clinical PharmacologyCrinetics Pharmaceuticals is seeking a highly experienced Senior Director, Clinical Pharmacology to join our team. As a key member of our development team, you will be responsible for developing clinical pharmacology strategy and leading the design, execution, interpretation, and reporting of Phase 1 clinical...
-
Director of Clinical Pharmacology
3 weeks ago
San Diego, California, United States Kumquat Biosciences Inc Full timeJob DescriptionAt Kumquat Biosciences Inc, we are seeking a highly skilled Director of Clinical Pharmacology to join our team. This is an exciting opportunity to lead the development and execution of clinical pharmacology strategies for small molecule assets in our portfolio.Key ResponsibilitiesDevelop and execute clinical pharmacology and pharmacometrics...
-
Senior Director, Clinical Pharmacology Expert
11 hours ago
San Diego, California, United States Crinetics Pharmaceuticals Full timeCrinetics Pharmaceuticals: A Leader in Endocrine TherapiesCrinetics Pharmaceuticals is a pioneering company in the field of endocrine therapies, dedicated to developing innovative treatments for rare endocrine disorders and endocrine-related cancers. Our team of experts is passionate about making a meaningful difference in the lives of patients.Job...
-
Clinical Pharmacology Director
4 weeks ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeAssociate Director, Clinical PharmacologyAbout the RoleWe are seeking an experienced Associate Director to lead our Clinical Pharmacology team. As a key member of our development team, you will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from First-in-Human to post-registration.Key...
-
Clinical Pharmacology Director
4 weeks ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeJob Summary:The Clinical Pharmacology Director will be responsible for creating model-based drug development plans, designing, conducting, and interpreting Phase 1 studies, supporting Phase 2/3 studies, and representing the function on study and project teams. This position requires a strong understanding of PK-PD and Pop PK-PD concepts and analysis, phase...
-
Quantitative Clinical Pharmacology Manager
3 weeks ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeUnlock Your Potential in Clinical PharmacologyDaiichi Sankyo, Inc. is a global pharmaceutical innovator dedicated to creating and supplying innovative therapies to improve healthcare standards worldwide. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to addressing diversified, unmet medical needs of people...
-
Associate Director of Clinical Pharmacology
2 weeks ago
South San Francisco, California, United States Pliant Therapeutics, Inc. Full timeJob Title: Associate Director of Clinical PharmacologyPliant Therapeutics, Inc. is a leading biopharmaceutical company dedicated to the discovery and development of innovative therapies for fibrotic diseases. We are seeking an experienced Associate Director of Clinical Pharmacology to join our team.About the Role:The Associate Director of Clinical...
-
Associate Director of Clinical Pharmacology
2 weeks ago
South San Francisco, California, United States Pliant Therapeutics, Inc. Full timeJob Title: Associate Director of Clinical PharmacologyPliant Therapeutics, Inc. is a leading biopharmaceutical company dedicated to the discovery and development of innovative therapies for fibrotic diseases. We are seeking an experienced Associate Director of Clinical Pharmacology to join our team.Job Summary:The Associate Director of Clinical Pharmacology...
-
Senior Research Scientist, Pharmacology
7 hours ago
San Diego, California, United States Kyowa Kirin, Inc.- U.S. Full timeJob Title: Senior Research Scientist, PharmacologyAt Kyowa Kirin, Inc.- U.S., we are seeking a highly skilled and experienced Senior Research Scientist to lead our Cell and Gene Therapy Pharmacology Team.Job Summary:The Senior Research Scientist will be responsible for providing leadership, technical, and analytical expertise in pharmacologic evaluation of...
-
San Francisco, California, United States Pliantrx Full timeJob Title: Senior Manager, Clinical PharmacologyPliant Therapeutics is a leading biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. As a Senior Manager, Clinical Pharmacology, you will play a critical role in shaping the company's clinical pharmacology strategy and ensuring the successful development...
-
South San Francisco, California, United States Recruits Lab (We're hiring) Full timeAbout the RoleWe are seeking a highly accomplished Senior Director of Pharmacokinetics and Clinical Pharmacology to drive innovation in oncology therapies. As a key member of our team, you will lead the development of next-generation oncology treatments, leveraging cutting-edge pharmacometric techniques and advanced analytical methodologies.Key...
-
Senior Director, In Vivo Pharmacology Lead
22 hours ago
South San Francisco, California, United States HireMinds Full timeJob Title: Senior Director, In Vivo PharmacologyOur client is an innovative biotech startup focused on developing a groundbreaking gene therapy platform that uses a unique non-viral approach. The Senior Director, In Vivo Pharmacology, will be a pivotal member of the research team, responsible for designing, implementing, and overseeing in vivo studies that...
-
Toxicology Director
3 weeks ago
San Diego, California, United States Clinical Dynamix Full timeJob Title: Executive Director, ToxicologyClinical Dynamix is seeking an experienced Executive Director, Toxicology to lead our Toxicology team. As a key member of our Research and Development team, you will be responsible for overseeing and directing the activities of the Toxicology group.Key Responsibilities:Provide strategic and operational direction to...
-
Senior Manager Clinical Operations Lead
3 weeks ago
San Diego, California, United States Autobahn Therapeutics, Inc. Full timeJob Title: Senior Manager Clinical OperationsAutobahn Therapeutics, Inc. is seeking a highly skilled Senior Manager Clinical Operations to join its team to oversee clinical pharmacology studies.About UsAutobahn Therapeutics, Inc. is a biotech company focused on improving life health for people affected by CNS disorders. We leverage a deep understanding of...
-
Director of In Vivo Pharmacology
2 days ago
South San Francisco, California, United States Vertex Ventures HC Full timeAbout SonoTheraSonoThera is a pioneering biopharmaceutical company that has developed a groundbreaking ultrasound-guided non-viral gene therapy platform. Our innovative platform enables the precise and non-invasive delivery of large payloads of diverse formats (DNA, RNA, and combinations thereof) to various organs in the body, providing durable expression...
-
Toxicology Director
1 month ago
San Diego, California, United States Clinical Dynamix Full timeJob Title: Executive Director, ToxicologyClinical Dynamix is seeking an experienced Executive Director, Toxicology to lead our Toxicology group. As a key member of our Research and Development team, you will be responsible for overseeing and directing the activities of the Toxicology group, ensuring that toxicology studies are conducted in line with...
-
Senior Director of In Vivo Pharmacology
3 weeks ago
South San Francisco, California, United States Meet Full timeJob SummaryWe are seeking a highly experienced Senior Director to lead our In Vivo Pharmacology team. As a key member of our Research organization, you will be responsible for designing, implementing, and overseeing in vivo pharmacology studies to support our gene therapy programs.Key ResponsibilitiesProvide strategic leadership and direction to the In Vivo...
-
Senior Director, In Vivo Pharmacology
2 days ago
South San Francisco, California, United States Vertex Ventures HC Full timeAbout SonoTheraSonoThera is a pioneering biopharmaceutical company that has developed a groundbreaking ultrasound-guided non-viral gene therapy platform. Our innovative platform enables precise and non-invasive delivery of large payloads of diverse formats (DNA, RNA, and combinations thereof) to various organs in the body, providing durable expression with...
-
Associate Director, Pharmacology Expert
20 hours ago
South San Francisco, California, United States Cytokinetics Full timeJob Title: Associate Director, PharmacologyCytokinetics is a pioneering biopharmaceutical company dedicated to advancing innovative treatments for debilitating diseases affecting cardiac muscle performance. As a leader in muscle biology, we are developing novel small molecule drug candidates to address unmet medical needs.Job Summary:We are seeking an...