Associate Director/Director, Clinical Pharmacology

Summary

Join Kura Oncology, a leading biotech company committed to precision medicine for cancer treatment, and be part of a team making a meaningful impact. As an Associate Director/Director of Clinical Pharmacology, you will play a core role in developing and implementing nonclinical and clinical ADME strategies for oncology programs. You will provide clinical pharmacology leadership, contribute to regulatory document preparation, and collaborate with cross-functional teams. Success requires demonstrated excellence in drug discovery and development, a strong work ethic, and a values-driven approach. Kura offers a competitive compensation package, including generous benefits, equity, and a bonus structure. The company fosters a collaborative and supportive work environment.

Requirements

• Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, or a closely related discipline with 5+ years of experience for Associate Director or 8+ years of experience for Director in clinical pharmacology, modeling & simulation, drug metabolism and/or pharmacokinetics within a large pharma and / or biotech companies
• Experience with nonclinical and clinical pharmacokinetic protocol design with experience working with CRO's is required
• Experience in Model Informed Drug Development
• Strong organizational and time-management skills including the ability to manage several projects simultaneously
• A strong entrepreneurial spirit and a desire to be hands on
• Strong analytical and critical thinking skills, and attention to details
• Demonstrated creativity in problem solving
• Ability to effectively collaborate as part of cross-functional teams and with research partners
• Excellent professional interpersonal skills, particularly oral and written communication skills and be able to work in a multidisciplinary team environment
• Extensive knowledge of regulatory/guidance requirements (i.e. GLP, FDA, EMA) best practices pharmacokinetic/pharmacodynamic testing and risk assessment based on target indication

Responsibilities

• Develop, drive, and implement nonclinical and clinical ADME strategies
• Provide clinical pharmacology leadership on multi-disciplinary teams for oncology programs including modeling & simulation to satisfy world-wide regulatory requirements
• Provide clinical and nonclinical pharmacokinetic expertise to projects including study design, data analysis and interpretation
• Develop population PK, exposure-response, mechanistic PK/PD, PBPK and QSP models, as needed, to evaluate risk/benefit and facilitate drug development decisions
• Experience in developing clinical pharmacology and nonclinical strategy and execute studies such as but not limited to drug-drug interaction studies, specific population, BA/BE, and food effect
• Provide clinical pharmacology support and leadership in preparation of various regulatory documents including study protocol, CSR, Investigator's Brochure, Clinical Pharmacology section of INDs, CTAs, BLAs and/or NDAs, and clinical pharmacology section of package inserts
• Participate in meetings with regulatory agencies and respond to regulatory queries

Benefits

• Career advancement/ development opportunities
• Competitive comp package
• Bonus
• 401K + Employer contributions
• Generous stock options
• ESPP Plan
• 20 days of PTO to start
• 18 Holidays (Including Summer & Winter Break)
• Generous Benefits Package with a variety of plans available with a substantial employer match
• Paid Paternity/Maternity Leave
• In-Office Catered lunches
• Home Office Setup
• Lifestyle Spending Stipend
• Commuter Stipend (Boston Office)
• Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!