Associate Director, Clinical Pharmacology - Oncology

*This is a site-based position in Foster City, CA or Parsippany, New Jersey

POSITION OVERVIEW:

With considerable independence, you will typically lead clinical pharmacology strategy and clinical pharmacology studies in Oncology with a focus on combinations involving IO agents, ADCs etc from first-in human through approval and post-marketing activities including pediatric development. Working in collaboration with others, you are responsible for various aspects of clinical pharmacology program activities. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical pharmacology study start-up/execution/close out, PK-PD and related analysis, interpretation and reporting, and support of regulatory filings. You will typically lead clinical pharmacology cross-functional study sub-teams, which entails coordinating and providing direction to internal and external partners involved in clinical pharmacology study design and execution. You will champion model-based drug discovery and development and serve as a clinical pharmacology specialist to cross-functional partners.

EXAMPLE RESPONSIBILITIES:

• As a member of a drug development team, routinely provides input into product development strategies and/or research or clinical development plans for assigned products / projects.
• Typically authors the clinical pharmacology plan for one or more products in the assigned disease or therapeutic area.
• Typically leads and manages design and conduct of clinical pharmacology studies of increasing complexity, which includes responsibilities for leading the respective cross-functional study team.
• With input from others, 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. Addresses clinical issues arising from 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.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
 

Minimum Education & Experience

• PharmD or PhD in pharmaceutical sciences, pharmacology or related discipline with 5+ years’ relevant research or clinical experience.
• Relevant experience in Oncology therapeutic area
• 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, conducting PK-PD, Pop PK-PD and related analyses, and contributing to regulatory filings, clinical publications and presentations.
• Proven effectiveness managing clinical project deliverables through matrix management.
• Experience supporting clinical publications and presentations is strongly preferred.

Knowledge & Other Requirements

• 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.
• Thorough knowledge of FDA and EMA regulations, ICH guidelines, and GCP governing the conduct of clinical studies. Has significant knowledge of pharmaceutical regulatory requirements related to clinical pharmacology.
• Has advanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects.
• Demonstrable ability to effectively apply business acumen to strategic scientific projects.
• Significant knowledge of PK-PD, Pop PK-PD analyses and techniques and the physiological/pharmacological aspects of drugs.
• Able to serve as a clinical pharmacology specialist in authoring clinical pharmacology protocols, development plans and modeling and simulation plans, conducting of PK-PD, Pop PK-PD and related analyses, and literature and regulatory guidelines.
• Strong communication and organizational skills.
• When needed, ability to travel.