Specific Job Responsibilities
- Provide input into product development strategies and/or research/clinical development plans.
- Author clinical pharmacology plans for one or more products.
- Lead and manage design and conduct of clinical pharmacology studies; lead cross-functional study teams.
- Design study protocols, data analysis, and modeling/simulation plans.
- Lead study protocol review discussions (scientific/procedural aspects).
- Implement and monitor studies with cross-functional partners and sites; address arising clinical issues.
- Direct internal/external study partner activities and resources; manage timelines to ensure accurate execution.
- Conduct PK/PD analyses; author study documentation, analysis/management plans, and scientific materials.
- Analyze/interpret and author documents for clinical and regulatory submissions.
- Present project updates and milestones; may support business development/due diligence.
- Represent clinical pharmacology with regulatory agencies; anticipate trial issues and develop solutions.
- Ensure compliance with Good Clinical Practice and company SOPs.
Basic Qualifications
- Bachelorβs + 10 years OR Masterβs + 8 years OR PhD/PharmD + 5 years.
Preferred Qualifications / Skills
- PhD or PharmD in pharmaceutical sciences/pharmacology.
- Strong communication skills; experience with WinNonlin (or similar) for PK analysis.
- Experience leading cross-functional teams/matrix management; clinical pharmacology concept/protocol design; authoring development plans.
- Experience with regulatory filings; clinical publications/presentations; fast learner; adaptable; FDA/EMA/ICH/GCP knowledge; apply business acumen; ability to travel.
People Leader Accountabilities
- Create inclusion; develop talent; empower teams.
Compensation & Benefits (if applicable)
- Bay Area: $195,670β$253,220; Other US: $177,905β$230,230. May include bonus/stock incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions
- Please apply via the Internal Career Opportunities portal in Workday.