Sr. Director, DMPK, Global Pharmaceutical Company Gastrointestinal | Immunology | Pharmacology Greater Boston Area$275,000 - $320,000 + bonus +complete benefits packageA 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.
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