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Director, Clinical Pharmacology and Development
2 months ago
The Director of Clinical Pharmacology and Development will play a crucial role in supporting the clinical and non-clinical pharmacology activities at SpringWorks Therapeutics. This position involves working on clinical development teams to develop and implement the clinical pharmacology strategy, design clinical pharmacology studies, develop study protocols, and write clinical pharmacology study reports.
This role will also involve collaborating closely with internal clinical development teams, Contract Research Organizations (CROs), and study collaborators to file regulatory documents and execute clinical development plans. Additionally, this role will lead, manage, and develop other team members as direct reports and/or in a matrix management environment.
Key Responsibilities- Represent Clinical Pharmacology as a member of program, clinical sub-team, clinical trial working teams by contributing to clinical development strategy, clinical trial design, clinical study protocols, executing and coordinating clinical trial conduct, and finalizing clinical study reports.
- Develop and execute program-specific Clinical Pharmacology strategy and plan, aligning plans with cross-functional study and program teams.
- Design, conduct, and provide scientific interpretation of Clinical Pharmacology studies, providing effective Clinical Pharmacology support to patient trials. Lead internal sub-teams to define strategy for compound development.
- Participate in cross-departmental teams, company-wide initiatives, and work streams.
- Work with external partners to provide Clinical Pharmacology support to new and ongoing studies.
- Manage CROs for DMPK and Clinical Pharmacology-related studies and activities, including developing and negotiating study timelines, ensuring accuracy of project delivery, and proactively identifying hurdles and providing solutions.
- Partner with outsourcing management to coordinate vendor selection, proposal negotiation, and budgetary oversight as assigned.
- Co-author regulatory documents for submission to global health authorities, including eCTD sections for IND and NDA, Investigators Brochure (IB), and Briefing Documents.
- Lead, manage, and develop direct reports and other junior members of the clinical pharmacology team.
- Perform other duties and responsibilities as assigned.
- Education: Advanced Degree in clinical pharmacology, pharmaceutical sciences, or related areas (e.g., pharmacokinetics, pharmacology, drug metabolism, or etc.). (Ph.D. or Pharm.D. preferred)
- 4+ years with Doctoral degree or 7+ years with Master's degree of relevant experience in clinical drug development in industry or academic/research.
- Experience formulating and executing Clinical Pharmacology strategies, including design, interpretation, and reporting of clinical pharmacology studies, is required.
- Direct interaction with the FDA and international regulatory authorities is preferred.
- A working knowledge or previous experience with pharmacokinetic/pharmacodynamics, drug-drug interactions, PK/PD data management/analysis, and clinical development is a plus.
- Knowledge of ICH guidelines in the design, analysis, and interpretation of clinical pharmacology studies.
- Familiarity with related disciplines (e.g., bioanalysis, biostatistics, toxicology, regulatory affairs, clinical operations) in the drug development process.
- Broad familiarity with the drug development process and Model Informed Drug Development, particularly for oncology and/or rare disease, is highly desirable, as is prior experience working with CROs.
- Working knowledge of common tools for quantitative clinical pharmacology, such as NONMEM, Monolix, R, WinNonlin, SimCYP, or GastroPlus, and ability to perform non-compartmental pharmacokinetic analysis (NCA) are required.
- Expertise in PK/PD modeling is a plus but is not required.
- Knowledge or experience with developing biomarkers, targeted therapies, or companion diagnostics is a plus.
- Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams' performance.
- Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
- Ability to travel occasionally, including overnight stays, driven by business needs.
