Sr. Manager, Clinical Pharmacology

Company: GILEAD Sciences
Location: San Mateo
Posted on: February 5, 2025

Job Description:

For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.Job DescriptionPOSITION 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.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 analysisLeads 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 analysisExperience 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.The salary range for this position is: $169,320.00 - $219,120.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.For additional benefits information, visit: * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.For jobs in the United States:As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, -genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com -for assistance.For more information about equal employment opportunity protections, please view the -'Know Your Rights' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.SummaryLocation: United States - California - Foster CityType: Full time

Keywords: GILEAD Sciences, San Rafael , Sr. Manager, Clinical Pharmacology, Executive , San Mateo, California