Senior Director, DMPK Project Leader

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the submission of NDAs for DMPK.

• Provide high-quality DMPK insights and data to projects within set timelines.

• Leverage DMPK expertise to support and influence compound profiling, project advancement, and strategic direction.

• Compute PK and toxicokinetic parameters, assess safety margins, and convey results and interpretations to project teams and internal governance entities.

• Lead, coordinate, and collaborate with DMPK colleagues, clinical pharmacologists, and toxicologists in project-related tasks.

• Develop clear presentations for internal governance entities.

• Ensure the execution of all DMPK-related activities, including nonclinical PK experiments, in vitro ADME, biotransformation studies, bioanalytical analysis, and toxicokinetic evaluations.

• Collaborate with discovery and development teams to pinpoint lead candidates with optimal DMPK characteristics and advance candidates into nonclinical and clinical stages.

⛳️ Requirements

• Ph.D. in Pharmaceutical Sciences, Pharmacology, or a related discipline.

• At least 10 years of industry experience in a biotech or pharmaceutical environment.

• Expertise in DMPK sciences with a solid understanding of drug discovery and development processes.

• Strong analytical and problem-solving abilities.

• Proven experience in DMPK project leadership.

• Previous involvement in the discovery and/or development of CNS drug candidates.

• Familiarity with regulatory submissions, including NDAs for small molecules.

• Knowledge, experience, and proficiency in facilitating GLP-compliant studies.

• Comprehensive understanding of all DMPK assays, including the application of in silico tools for PK prediction.

• Proficiency with Phoenix WinNonlin and other software for NCA and PK modeling in small molecule drug discovery and development.

• Proven capability to work cross-functionally and communicate scientific findings clearly and effectively.

• Collaborative mindset and a sense of urgency in operations.

• Strong, proactive communication skills.

• Position is based in the US with occasional travel requirements.

🏝️ Benefits

• Company bonus based partly on company and individual performance.

• Company-sponsored 401(k).

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug benefits.

• Healthcare and/or dependent day care flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, including an employee assistance program and fitness benefits.

• Employee clubs and activities.