Associate Clinical Pharmacology Director
Gilead Sciences
5 hours ago
On-site
Parsippany, NJ
Clinical Research and Development
Specific Job 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.
- Authors the clinical pharmacology plan for one or more products in the assigned disease/therapeutic area.
- Leads and manages design and conduct of clinical pharmacology studies of increasing complexity, including leading the respective cross-functional study team.
- Designs clinical pharmacology study protocols, study data analysis, modeling and simulation plans (with input from others).
- Leads study protocol review discussions regarding 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 the studies.
- Directs activities and resources for internal and external study partners.
- Manages study timelines and resources to ensure timely and accurate execution.
- Conducts PK-PD and related analyses; provides clinical pharmacology input into or authors study documentation, data analysis/management plans, and scientific presentations/literature.
- Analyzes, interprets, and authors documents for clinical and regulatory submissions.
- Presents project updates and 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 clinical trial problems and develops solutions using precedents and original thinking.
- Adheres to regulatory requirements, Good Clinical Practice (GCP), and Gilead SOPs.
Basic Qualifications:
- Bachelor’s degree and 10 years’ experience OR
- Master’s degree and 8 years’ experience OR
- PhD/PharmD and 5 years’ experience.
Preferred Qualifications / Required Skills:
- PhD or PharmD in pharmaceutical sciences, pharmacology, or related discipline.
- Excellent verbal, written, and interpersonal communication skills.
- Experience using pharmacokinetic program and analysis software (e.g., WinNonlin).
- Experience leading small cross-functional teams and managing deliverables through matrix management.
- Significant experience leading clinical pharmacology study concept/protocol design and authoring clinical pharmacology development plans.
- Strong preference: experience contributing to regulatory filings.
- Experience supporting clinical publications and presentations.
- Ability to be a fast learner; flexible and adaptable to change.
- Thorough knowledge of FDA and EMA regulations, ICH guidelines, and GCP; significant knowledge of pharmaceutical regulatory requirements related to clinical pharmacology.
- Ability to apply business acumen to strategic scientific projects.
- When needed, ability to travel.
People Leader Accountabilities:
- Create Inclusion.
- Develop Talent (coach employees on performance and future potential).
- Empower Teams (align team goals/purpose to organizational objectives; remove barriers).
Benefits (if applicable/explicitly stated):
- Benefits include company-sponsored medical, dental, vision, and life insurance plans.
Application Instructions:
- Please apply via the Internal Career Opportunities portal in Workday.
- 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.
- Authors the clinical pharmacology plan for one or more products in the assigned disease/therapeutic area.
- Leads and manages design and conduct of clinical pharmacology studies of increasing complexity, including leading the respective cross-functional study team.
- Designs clinical pharmacology study protocols, study data analysis, modeling and simulation plans (with input from others).
- Leads study protocol review discussions regarding 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 the studies.
- Directs activities and resources for internal and external study partners.
- Manages study timelines and resources to ensure timely and accurate execution.
- Conducts PK-PD and related analyses; provides clinical pharmacology input into or authors study documentation, data analysis/management plans, and scientific presentations/literature.
- Analyzes, interprets, and authors documents for clinical and regulatory submissions.
- Presents project updates and 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 clinical trial problems and develops solutions using precedents and original thinking.
- Adheres to regulatory requirements, Good Clinical Practice (GCP), and Gilead SOPs.
Basic Qualifications:
- Bachelor’s degree and 10 years’ experience OR
- Master’s degree and 8 years’ experience OR
- PhD/PharmD and 5 years’ experience.
Preferred Qualifications / Required Skills:
- PhD or PharmD in pharmaceutical sciences, pharmacology, or related discipline.
- Excellent verbal, written, and interpersonal communication skills.
- Experience using pharmacokinetic program and analysis software (e.g., WinNonlin).
- Experience leading small cross-functional teams and managing deliverables through matrix management.
- Significant experience leading clinical pharmacology study concept/protocol design and authoring clinical pharmacology development plans.
- Strong preference: experience contributing to regulatory filings.
- Experience supporting clinical publications and presentations.
- Ability to be a fast learner; flexible and adaptable to change.
- Thorough knowledge of FDA and EMA regulations, ICH guidelines, and GCP; significant knowledge of pharmaceutical regulatory requirements related to clinical pharmacology.
- Ability to apply business acumen to strategic scientific projects.
- When needed, ability to travel.
People Leader Accountabilities:
- Create Inclusion.
- Develop Talent (coach employees on performance and future potential).
- Empower Teams (align team goals/purpose to organizational objectives; remove barriers).
Benefits (if applicable/explicitly stated):
- Benefits include company-sponsored medical, dental, vision, and life insurance plans.
Application Instructions:
- Please apply via the Internal Career Opportunities portal in Workday.