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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Director of Quantitative Systems Pharmacology
We're looking to connect with strong clinical pharmacologists who stem from the Quantitative Systems Pharmacology side and are eager to join a well-established pharmaceutical who keeps developing groundbreaking products. Key Responsibilities: Strategic Leadership: Develop and execute the strategic vision for quantitative systems pharmacology (QSP) and data analytics to support the discovery, development, and optimization of therapeutic candidates. QSP Modeling: Lead the design and application of QSP models to predict drug behavior, optimize dosing regimens, and support decision-making throughout the drug development process. Data Integration: Oversee the integration of diverse data sources, including preclinical, clinical, and real-world data, to inform pharmacology models and drive actionable insights. Cross-Functional Collaboration: Work closely with research, clinical, regulatory, and commercial teams to ensure that QSP and data analytics efforts are aligned with broader organizational goals and regulatory requirements. Regulatory Support: Provide expertise and support in the preparation of regulatory submissions, ensuring that QSP models and data analytics are effectively communicated to regulatory agencies Qualifications: Education: Ph.D. in Pharmacology, Systems Biology, Computational Biology, or a related field; advanced training in quantitative systems pharmacology is highly desirable. Experience: Minimum of 10 years of experience in QSP and data analytics within the biotechnology or pharmaceutical industries, with a proven track record of success in drug development. Technical Expertise: Deep expertise in QSP modeling, pharmacometrics, computational biology, and data analytics tools (e.g., MATLAB, R, Python).
US$200000 - US$225000 per year
Boston
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Director QSP
We're looking to connect with strong clinical pharmacologists who stem from the Quantitative Systems Pharmacology side and are eager to join a well-established pharmaceutical who keeps developing groundbreaking products. Key Responsibilities: Strategic Leadership: Develop and execute the strategic vision for quantitative systems pharmacology (QSP) and data analytics to support the discovery, development, and optimization of therapeutic candidates. QSP Modeling: Lead the design and application of QSP models to predict drug behavior, optimize dosing regimens, and support decision-making throughout the drug development process. Data Integration: Oversee the integration of diverse data sources, including preclinical, clinical, and real-world data, to inform pharmacology models and drive actionable insights. Cross-Functional Collaboration: Work closely with research, clinical, regulatory, and commercial teams to ensure that QSP and data analytics efforts are aligned with broader organizational goals and regulatory requirements. Regulatory Support: Provide expertise and support in the preparation of regulatory submissions, ensuring that QSP models and data analytics are effectively communicated to regulatory agencies Qualifications: Education: Ph.D. in Pharmacology, Systems Biology, Computational Biology, or a related field; advanced training in quantitative systems pharmacology is highly desirable. Experience: Minimum of 10 years of experience in QSP and data analytics within the biotechnology or pharmaceutical industries, with a proven track record of success in drug development. Technical Expertise: Deep expertise in QSP modeling, pharmacometrics, computational biology, and data analytics tools (e.g., MATLAB, R, Python).
US$200000 - US$225000 per year
Boston
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Director of Clinical Pharmacology
We are seeking an experienced and highly motivated Director of Clinical Pharmacology to lead our client's clinical pharmacology efforts across multiple therapeutic areas. The successful candidate will be responsible for designing, implementing, and interpreting clinical pharmacology studies to support the development and registration of new therapies. This role requires a deep understanding of pharmacokinetics (PK), pharmacodynamics (PD), modeling and simulation, and regulatory requirements. Key Responsibilities: Leadership & Strategy: Lead and develop a high-performing clinical pharmacology team. Provide strategic input into clinical development plans, ensuring optimal study designs and regulatory strategies. Collaborate with cross-functional teams, including clinical development, regulatory affairs, and biostatistics, to ensure alignment on program goals. Study Design & Execution: Oversee the design and execution of clinical pharmacology studies, including first-in-human, dose-ranging, drug-drug interaction, special population, and other necessary studies. Ensure the appropriate selection of biomarkers and PK/PD endpoints to inform dose selection and clinical decision-making. Data Analysis & Interpretation: Lead the interpretation of clinical pharmacology data, including PK/PD modeling and simulation. Provide expert guidance on the implications of study findings for drug development programs. Ensure timely delivery of high-quality clinical pharmacology sections of regulatory documents, including INDs, NDAs, and BLAs. Regulatory Interaction: Serve as the clinical pharmacology representative in meetings with regulatory agencies. Provide scientific and strategic input into regulatory submissions, responses to agency queries, and advisory committee presentations. Innovation & Continuous Improvement: Stay abreast of emerging trends and technologies in clinical pharmacology and drug development. Implement innovative approaches to enhance the efficiency and effectiveness of clinical pharmacology activities. Qualifications: PhD, PharmD, or MD with specialized training in clinical pharmacology, pharmacokinetics, pharmacodynamics, or a related field. A minimum of 10 years of experience in clinical pharmacology within the pharmaceutical or biotechnology industry. Proven track record of leading clinical pharmacology efforts for drug development programs from early phase through registration. Expertise in PK/PD modeling and simulation, and experience with relevant software tools (e.g., NONMEM, WinNonlin). Strong knowledge of regulatory requirements and guidelines (FDA, EMA, ICH) related to clinical pharmacology. Excellent communication and leadership skills, with the ability to work effectively in cross-functional teams. Strong problem-solving abilities and a strategic mindset.
US$200000 - US$210000 per year
New Jersey
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