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.
