Remote Director, Clinical Pharmacology

Summary

Join a dynamic team at SpringWorks Therapeutics as the Director, Clinical Pharmacology. This role will support clinical and nonclinical pharmacology activities, develop and implement clinical pharmacology strategies, design studies, and lead teams.

Requirements

• Education: Advanced Degree in clinical pharmacology, pharmaceutical sciences, or related areas (e.g.: pharmacokinetics, pharmacology, drug metabolism or etc.). (PhD or PharmD 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 preferred Experience Bullet
• 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. Ability to perform non-compartmental pharmacokinetic analysis (NCA). Expertise in PK/PD modeling is a plus but is not required
• Knowledge or experience with developing biomarkers, targeted therapies or companion diagnostics

Responsibilities

• Independently 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. Align plans with cross functional study and program teams
• Design, conduct, and provide scientific interpretation of Clinical Pharmacology studies and provide effective Clinical Pharmacology support to patient trials
• Lead internal sub-teams to define strategy for compound development
• Actively 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 inclusive of developing and negotiating study timelines; ensuring accuracy of project delivery and pro-actively 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

Benefits

Comprehensive benefits package for our team of SpringWorkers and their families, including competitive compensation, annual cash bonuses and equity grants, 401K matching, fully covered medical, dental, and vision plans, and a full week of holiday break at year end