Senior Clinical Pharmacologist - Inflammation

Job Description

Senior Clinical Pharmacologist - Inflammation

POSITION OVERVIEW:

With increasing independence, you will typically lead clinical pharmacology studies of moderate complexity in Inflammation, which range from first-in human through approval and post-marketing activities. 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, provides input into product development strategies and/or research or clinical development plans for assigned products / projects.
• May author 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 moderate complexity, which typically includes responsibilities for leading the respective cross-functional study team.
• With input from others, designs clinical pharmacology study protocols, study data analysis
• 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.
• Represents clinical pharmacology for the assigned project team in interactions with regulatory agencies.
• Presents project updates and other key milestone information to cross-functional partners and stakeholders.
• 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 2+ years’ relevant research or clinical experience in the biopharma industry, healthcare, consulting, academia or a related environment.
• MS in pharmaceutical sciences, pharmacology or related discipline with 8+ years’ relevant research or clinical experience.
• BS in pharmaceutical sciences, pharmacology or related discipline with 10+ years’ relevant research or clinical experience.
• Experience working on and with cross-functional project / program teams in drug research or development.
• Experience supporting clinical pharmacology study design and data analysis,
• Experience supporting clinical publications and presentations is strongly preferred.
• Experience supporting regulatory filings is highly desirable.

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.
• Proven analytical abilities as demonstrated through past experience and/or academic research.
• Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
• Has advanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects.
• Demonstrates a strong understanding of applied medicine.
• Understands the role and responsibilities of Biometrics, Clinical Operations, Regulatory and Drug Safety in the design, conduct and close-out of clinical studies.
• Able to anticipate problems that may arise in clinical trial design.
• Significant knowledge of PK-PD, Pop PK-PD and regulatory considerations / guidances and related principles and practices.
• Able to manage scientific, operational and administrative aspects of teams.
• 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.