Associate Director – Clinical Pharmacology – Virology
| Company | Gilead Sciences |
|---|---|
| Location | San Mateo, CA, USA, Parsippany-Troy Hills, NJ, USA |
| Salary | $195670 – $253220 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- Doctorate and 5+ years of relevant research or clinical experience OR
- Master’s and 8+ years of relevant research or clinical experience OR
- Bachelor’s and 10+ years of relevant research or clinical experience
- Thorough knowledge of FDA and EMA regulations, ICH guidelines, and GCP governing the conduct of clinical studies
- Significant knowledge of PK-PD, Pop PK-PD analyses and techniques and the physiological/pharmacological aspects of drugs
- Strong communication and organizational skills
Responsibilities
- Provides input into product development strategies and/or research or clinical development plans for assigned products/projects
- Authors the clinical pharmacology plan for one or more products in the assigned disease or therapeutic area
- Leads and manages design and conduct of clinical pharmacology studies of increasing complexity
- Designs clinical pharmacology study protocols, study data analysis, modeling and simulation plans
- Leads study protocol review discussions concerning scientific and procedural aspects of pharmacology study design
- Works with cross-functional partners and study sites to implement and monitor clinical pharmacology studies
- Directs the activities and resources for both internal and external study partners
- Manages study timelines and resources to ensure timely and accurate execution of clinical pharmacology studies
- Conducts PK-PD and related analyses and provides clinical pharmacology input into or otherwise authors study documentation, data analysis/management plans and scientific presentations or literature
- Analyzes, interprets and authors documents for clinical and regulatory submissions
- Presents project updates and other key milestone information to cross-functional partners and stakeholders
- May support business development/due diligence activities as a clinical pharmacology expert
- Represents clinical pharmacology for the assigned project team in interactions with regulatory agencies
- Anticipates problems that may arise in clinical trials and develops solutions for these using precedents and original thinking
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs
Preferred Qualifications
- Significant experience leading small cross-functional project teams in drug research or development
- Significant experience leading study concept and protocol design, authoring clinical pharmacology development plans and modeling and simulation plans
- Proven effectiveness managing clinical project deliverables through matrix management
- Relevant experience in Virology therapeutic area is strongly preferred
- Experience supporting clinical publications and presentations is strongly preferred
- Demonstrated ability to be a fast learner
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed
- Recognized for sustained scientific excellence
- Demonstrable ability to effectively apply business acumen to strategic scientific projects