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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Senior Director, Head of Pharmacometrics
We are seeking an experienced and visionary Senior Director to lead a Global Pharmacometrics team. In this pivotal role, you will oversee the development and execution of quantitative strategies that support drug discovery and development across multiple therapeutic areas. You will leverage advanced pharmacometric models and simulations to guide decision-making, optimize clinical development plans, and support regulatory submissions. Key Responsibilities: Develop and implement strategic plans for pharmacometric modeling to inform drug development processes. Lead and manage a team of pharmacometricians, providing mentorship and guidance to ensure high-quality, innovative solutions. Collaborate cross-functionally with clinical, regulatory, and research teams to integrate pharmacometric insights into drug development strategies. Oversee the design and execution of complex modeling and simulation studies to support clinical trial design and dose optimization. Ensure the effective communication of pharmacometric findings and recommendations to internal stakeholders and regulatory agencies. Drive innovation in pharmacometric methodologies and tools to enhance the drug development process. Qualifications: Ph.D. or equivalent advanced degree in pharmacometrics, pharmacokinetics, or a related field. Extensive experience (10+ years) in pharmacometrics, with a proven track record in a leadership role within the pharmaceutical industry. Strong expertise in pharmacometric modeling and simulation, with proficiency in relevant software tools. Demonstrated ability to lead and mentor a high-performing team.
US$290000 - US$310000 per year
United States of America
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Director/Senior Director, DMPK and Clinical Pharmacology
We are seeking an experienced and motivated Director to Senior Director of DMPK and Clinical Pharmacology to provide expert guidance on clinical pharmacology programs supporting drug discovery and clinical development. In this role, you will be responsible for authoring clinical protocols, study reports, and analyzing data (exposure/efficacy/safety) to support the development and registration of products. You will apply cutting-edge pharmacometrics methodologies to inform drug discovery, development, and regulatory decisions. Key Responsibilities: Lead the design, execution, and interpretation of clinical pharmacology programs, including model-based analyses such as population pharmacokinetic (PK), pharmacokinetic-pharmacodynamic (PK/PD) modelling, exposure-response (ER) analyses, quantitative systems pharmacology (QSP), and physiologically-based pharmacokinetic (PBPK) modelling. Develop customized clinical pharmacology and DMPK (Drug Metabolism and Pharmacokinetics) plans to advance drug development. Write, review, and edit regulatory submissions (INDs, NDAs, IBs) and respond to regulatory inquiries related to clinical pharmacology. Ensure timely and accurate delivery of clinical pharmacology studies, maintaining adherence to budgets and timelines. Lead the preparation of scientific publications, including abstracts, posters, oral presentations, and manuscripts. Collaborate with and manage CROs (Contract Research Organizations) to ensure compliance with protocols, quality standards, and timelines for pharmacometrics analyses. Qualifications: PhD or PharmD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutics, or related field. Extensive experience in clinical pharmacology with proficiency in model-based analyses (PK/PD, ER, QSP, PBPK). Knowledge of drug development processes and experience with regulatory submissions (IND, NDA). Strong scientific communication skills with a proven publication record. Experience in leading and managing cross-functional teams and external collaborations. Ability to manage multiple projects and adhere to strict timelines and budgets. 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$300000 per year + Medical, Dental, Vision, 401K
San Francisco
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