Associate Director of Clinical Pharmacology
Key Responsibilities: Lead and contribute to the clinical pharmacology strategy, ensuring alignment with overall development plans and therapeutic goals. Design and oversee clinical pharmacology studies, including pharmacokinetics (PK), pharmacodynamics (PD), dose optimization, and biomarker strategies. Interpret and analyze clinical pharmacology data, providing actionable insights to inform clinical development, regulatory submissions, and dosing strategies. Collaborate with internal teams, including clinical, regulatory, non-clinical, and project management, to drive the development and execution of clinical trials. Serve as the clinical pharmacology representative in cross-functional teams and meetings with regulatory agencies, ensuring that clinical pharmacology data supports clinical trial design and regulatory submissions. Lead the preparation and review of clinical pharmacology sections of regulatory documents, such as Investigational New Drug (IND) applications, Clinical Study Reports (CSRs), and New Drug Applications (NDAs). Stay current with emerging trends in clinical pharmacology, including new methodologies, technologies, and industry best practices. Qualifications: PhD, PharmD, or equivalent degree in pharmacology, pharmaceutical sciences, or a related field. Minimum of 7-10 years of experience in clinical pharmacology or a related area within the pharmaceutical or biotechnology industry. Strong understanding of pharmacokinetics, pharmacodynamics, and the application of these principles in clinical drug development. Proven experience in designing, analyzing, and interpreting clinical pharmacology studies. Expertise in regulatory requirements and experience with regulatory submissions (e.g., INDs, NDAs). Ability to work effectively in a team-oriented environment and across multiple therapeutic areas. Strong communication and interpersonal skills with a demonstrated ability to collaborate with cross-functional teams and external partners.
US$180000 - US$190000 per year
Boston
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Associate Director of Clinical Pharmacology
Key Responsibilities: Lead and contribute to the clinical pharmacology strategy, ensuring alignment with overall development plans and therapeutic goals. Design and oversee clinical pharmacology studies, including pharmacokinetics (PK), pharmacodynamics (PD), dose optimization, and biomarker strategies. Interpret and analyze clinical pharmacology data, providing actionable insights to inform clinical development, regulatory submissions, and dosing strategies. Collaborate with internal teams, including clinical, regulatory, non-clinical, and project management, to drive the development and execution of clinical trials. Serve as the clinical pharmacology representative in cross-functional teams and meetings with regulatory agencies, ensuring that clinical pharmacology data supports clinical trial design and regulatory submissions. Lead the preparation and review of clinical pharmacology sections of regulatory documents, such as Investigational New Drug (IND) applications, Clinical Study Reports (CSRs), and New Drug Applications (NDAs). Stay current with emerging trends in clinical pharmacology, including new methodologies, technologies, and industry best practices. Qualifications: PhD, PharmD, or equivalent degree in pharmacology, pharmaceutical sciences, or a related field. Minimum of 7-10 years of experience in clinical pharmacology or a related area within the pharmaceutical or biotechnology industry. Strong understanding of pharmacokinetics, pharmacodynamics, and the application of these principles in clinical drug development. Proven experience in designing, analyzing, and interpreting clinical pharmacology studies. Expertise in regulatory requirements and experience with regulatory submissions (e.g., INDs, NDAs). Ability to work effectively in a team-oriented environment and across multiple therapeutic areas. Strong communication and interpersonal skills with a demonstrated ability to collaborate with cross-functional teams and external partners.
Negotiable
Massachusetts
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Clinical Pharmacology and Pharmacometrics Director
A leading biotechnology firm focuses on developing innovative cancer therapies that target specific molecular pathways to improve patient outcomes. Their approach combines cutting-edge research with a deep understanding of cancer biology, advancing treatments that address significant unmet medical needs. With a diverse pipeline of both small molecules and biologics, the company strives to bring forward therapies that can make a meaningful impact on patients' lives. Through collaboration and scientific excellence, they are at the forefront of transforming cancer care with novel, precision-based treatments. Key Responsibilities Develop and execute clinical pharmacology and pharmacometrics strategies to advance Exelixis programs through all stages, from research to post-marketing. Serve as the clinical pharmacology lead on project teams, offering expertise in pharmacokinetics (PK)/pharmacodynamics (PD), biopharmaceutics, drug-drug interactions, and quantitative pharmacology. Guide the progression of small molecules and biologics through key development milestones, including IND/CTA submissions, EOP2 meetings, and marketing applications. Lead or oversee PK/PD and exposure-response analyses using advanced modeling and simulation techniques to support human PK predictions, dose selection and optimization, trial designs, risk/benefit assessments, Go/No-Go decisions, regulatory submissions, and publications. Collaborate with cross-functional teams, including Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations, and Regulatory Affairs, to meet project and corporate objectives. Drive the visibility of Exelixis' scientific expertise through publications and external collaborations. Work with both internal and external scientific experts to evaluate and implement new methodologies, maintaining cutting-edge techniques, models, and capabilities. Ensure adherence to SHE policies, GxP compliance, and regulatory standards throughout the clinical pharmacology programs. Experience Minimum of 8 years of experience in clinical pharmacology and pharmacometrics. Experience in the development of small molecules, large molecules, and new modalities. Experience with the submission of INDs, NDAs, BLAs, and global marketing applications. Oncology therapeutic area experience is preferred. Contributions to translational science and precision medicine objectives
US$230000 - US$250000 per year + Medical, Dental, Vision, 401K
San Francisco
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Director of Clinical Pharmacology
We have a current opportunity for a Director of Clinical Pharmacology on a permanent basis. The position is fully remote. Key Responsibilities: Lead the design, execution, and analysis of clinical pharmacology studies, including first-in-human (FIH), pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction (DDI) studies. Develop clinical pharmacology plans that support regulatory submissions (IND, NDA, BLA) and provide strategic input throughout all stages of drug development. Collaborate with clinical, regulatory, biostatistics, and other R&D teams to interpret data and guide decision-making in clinical development. Serve as the clinical pharmacology expert in interactions with regulatory authorities, presenting clinical pharmacology data and strategies. Support dose selection strategies, contribute to clinical trial design, and ensure optimal use of modeling and simulation approaches. Mentor and manage a growing team of clinical pharmacologists and pharmacometricians. Stay current on new scientific developments, regulatory guidelines, and industry trends in clinical pharmacology and related fields. Qualifications: PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, or a related discipline. 8+ years of experience in clinical pharmacology and drug development within the pharmaceutical or biotech industry. Proven track record of successfully leading clinical pharmacology programs from early to late-stage development. Must have large molcule and strong experience with MAB.
US$235000 - US$245000 per year
United States of America
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Clinical Pharmacology and Pharmacometrics Director
Company Overview: Join a leading biotechnology company dedicated to the discovery and development of innovative therapies for cancer and other serious diseases. We are seeking a highly motivated Clinical Pharmacology Lead to help advance our portfolio of small molecules and biologics through all stages of drug development. This role will be critical in shaping the pharmacology strategies that drive our programs from early research to post-marketing. Responsibilities Design and execute clinical pharmacology and pharmacometric plans to guide programs through all phases, from early research to post-market stages. Act as the lead for clinical pharmacology within project teams, offering expertise in areas such as PK/PD, biopharmaceutics, drug-drug interactions, and quantitative pharmacology. Advance small molecules and biologics through key development checkpoints, including regulatory submissions like IND/CTA, EOP2, and marketing approvals. Lead and/or perform PK/PD and exposure-response evaluations utilizing advanced modeling and simulation tools to inform human pharmacokinetics, dose optimization, trial design, risk/benefit assessments, decision points, regulatory documentation, and scientific publications. Collaborate closely with various departments, including Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations, and Regulatory teams, to achieve project and organizational goals. Increase external scientific presence and meet publication targets. Engage with internal and external experts to assess and incorporate the latest methodologies, models, and tools to ensure cutting-edge capabilities. Ensure adherence to SHE policies, GXP standards, and regulatory guidelines within clinical pharmacology initiatives. Benefits: Full-time employees become eligible for benefits on the first of the month following 30 days of continuous service. These benefits include: Medical Insurance Dental Insurance Vision Insurance Employer-Paid Basic Life Insurance Supplemental Life Insurance Employer-Paid Short-Term Disability Long-Term Disability 401(k) Plan Paid Time Off Paid Holidays
US$230000 - US$250000 per year + Medical, Dental, Vision, 401K
Alameda
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Senior Director, DMPK
Sr. Director, DMPK, Global Pharmaceutical Company Gastrointestinal | Immunology | Pharmacology Greater Boston Area $275,000 - $320,000 + bonus +complete benefits package A global pharmaceutical company is driving forward as a cutting-edge R&D organization, focused on pushing the boundaries of innovation to deliver transformative therapies to patients. With a commitment to research and development in key therapeutic areas, this company strives to bring groundbreaking treatments to those in need across the globe. Qualifications PhD with 15+ years of industry experience, or equivalent experience. In-depth knowledge of Inflammation & Immunology project portfolios, disease indications, and drug metabolism/pharmacokinetics (DMPK) considerations. Familiarity with various modalities such as small molecules, ASOs, gene therapy, cell therapy, and biologics. Extensive experience across all phases of drug development, from discovery through post-market support. Proven ability to provide strategic recommendations to senior management for key program decisions. Expertise in regulatory submissions (INDs, CTAs, NDAs, MAAs) and experience interfacing with regulatory bodies such as the FDA, EMA, and PMDA, in collaboration with the Regulatory function. Responsibilities Act as a key representative of Inflammation & Immunology within the DMPK&M Leadership Team. Actively participate in DMPK leadership meetings to provide updates on therapeutic areas, key issues, and progress milestones. Lead operational and strategy meetings involving DMPK staff working on the Inflammation & Immunology portfolio. Oversee study protocol reviews, supporting DMPK Project Team Representatives in experimental design and data interpretation. Review study reports and regulatory documents for scientific accuracy and alignment with human risk assessments. Provide ongoing mentorship and performance feedback to DMPK Project Team Representatives. Engage with the Global Head of DMPK, partnership leads, and functional heads to address strategic questions and resolve potential challenges. Provide strategic leadership for the Inflammation & Immunology portfolio within DMPK, making high-level decisions in consultation with senior leadership. Ensure the scientific and strategic soundness of clinical candidates, optimizing their development and characterization. Offer guidance on drug metabolism, bioanalysis, biomarkers, pharmacokinetics (PK), and PK/PD considerations at various stages of drug development. Ensure efficient execution of studies that support drug candidates within the portfolio. Provide scientific and strategic input to DMPK Project Team Representatives, supporting the development of therapeutic assets. Approve DMPK strategy components for all projects at critical milestones and review sections of internal project documentation. Stay informed on the latest competitive and regulatory trends in relevant therapeutic areas. Coordinate goals and resource allocation with leadership and communicate needs to DMPK functional leaders. Work closely with heads of ADME, Bioanalytical, Biomarker, and Translational Partner teams to ensure appropriate staffing for projects at critical stages. Review and approve regulatory documents on behalf of DMPK. Education & Competencies PhD with 15+ years of industry experience, or equivalent experience. Strong understanding of Inflammation & Immunology portfolio, disease areas, and relevant DMPK considerations for patients. Experience working with various therapeutic modalities including small molecules, ASOs, gene therapy, cell therapy, and biologics. Comprehensive experience across all stages of drug development, from discovery through to market support. Ability to provide strategic program recommendations to senior management. Experience with regulatory submissions (INDs, CTAs, NDAs, MAAs) and regulatory authority interactions (FDA, EMA, PMDA), with expertise in developing strategies for these interfaces in collaboration with Regulatory Affairs.
US$240000 - US$320000 per year
Boston
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