Associate Director, Clinical Pharmacology - Virology

Gilead Sciences, Inc.; New Jersey; On-site; USD 177,000 - 254,000; Full time

Job summary

A leading company seeks an Associate Director of Clinical Pharmacology to lead complex studies in Virology, focusing on HIV therapeutics. The role involves managing cross-functional teams, authoring clinical plans, and ensuring compliance with regulatory standards. Ideal candidates will have significant experience in drug development and a strong background in clinical pharmacology.

Qualifications

• Doctorate with 5+ years or Master's with 8+ years of clinical experience.
• Significant experience in drug research or development.

Responsibilities

• Lead clinical pharmacology studies focusing on HIV therapeutics.
• Manage design and conduct of complex clinical pharmacology studies.
• Collaborate on clinical pharmacology program activities.

Skills

Leadership

Communication

Flexibility

Organizational

Education

Doctorate

Master’s

Bachelor’s

Job description

Associate Director, Clinical Pharmacology - Virology

Associate Director, Clinical Pharmacology - Virology

United States - New Jersey - Parsippany, United States - California - Foster City Clinical Development & Clinical Operations Regular

*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 studies of increasing complexity in Virology focusing on HIV therapeutics, which range 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.

Key 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 fromclinical 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.

Basic Qualifications:

• 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

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, 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.
• 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.
• 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

People leader accountabilities

•Create inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

•Develop talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

•Empower teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The Foster City CA Salary Range is: $195,670.00 - $253,220.00

The Parsippany, NJ Salary Range is: $177,905 - $230,230

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Job Requisition ID R0045287

Full Time/Part Time Full-Time

Job Level Associate Director

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