Associate Director, Clinical Pharmacology

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

📋 Description

• Develop, implement, manage, and communicate comprehensive multidisciplinary Clinical Pharmacology development plans and strategies.

• Create innovative PK/PD study proposals and spearhead those initiatives.

• Assess advancements, strengths, weaknesses, opportunities, and threats in Clinical Pharmacology, PK/PD, and regulatory affairs.

• Oversee Clinical Pharmacology and PK/PD components across multiple projects.

• Design and strategize Phase 1–4 studies focusing on clinical pharmacology.

• Represent projects while providing context for data analysis, interpretation, mechanisms of action, disease specifics, and modeling outcomes.

• Draft regulatory documents, including protocols, study reports, population PK reports, exposure-response analyses, CTDs, label sections, investigator brochure sections, and white papers.

• Lead clinical pharmacology and biopharmaceutics meetings, representing Clinical Pharmacology in clinical strategy, asset development, studies, leadership, and cross-functional teams.

• Guide small cross-functional teams to form a cohesive clinical pharmacology stance for clinical, CMC, and regulatory groups.

• Write scientific publications, present at national and international conferences, and engage with KOLs and external stakeholders.

• Conduct due diligence evaluations, summarize findings, and represent Clinical Pharmacology in business development teams.

• Serve as the Clinical Pharmacology representative at regulatory meetings.

⛳️ Requirements

• PhD with generally 4+ years of relevant experience, or PharmD with typically 6+ years of experience.

• Master’s Degree or equivalent education with approximately 12+ years of experience.

• Bachelor’s Degree or equivalent education with around 14+ years of experience.

• Relevant expertise includes PK, PBPK, PK-PD, Pharmacometrics, systems pharmacology, drug metabolism, or transporters.

• Outstanding interpersonal skills.

• Capability to engage with functional representatives, internal and external KOLs, and lead teams effectively.

• Strategic thinking with a broad enterprise perspective.

• Established scientific record and technical abilities necessary for the role.

• Capacity to fulfill key leadership competencies, such as delivering business outcomes, persistence, respectful courage, generating innovative ideas, influencing peers, and accountability.

🏝️ Benefits

• Paid time off, which includes vacation, holidays, and sick leave.

• Comprehensive medical, dental, and vision insurance.

• 401(k) retirement plan.

• Eligibility to participate in long-term incentive programs.