Sr. Manager, Clinical Pharmacology

Company: GILEAD Sciences
Location: San Mateo
Posted on: January 17, 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 DescriptionSr. Manager, Clinical Pharmacology:POSITION OVERVIEW: You will play a supportive role in Oncology clinical pharmacology, which ranges 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. With guidance, you may directly lead design and conduct of clinical pharmacology studies, which will entail coordinating and providing direction to internal and external partners involved in clinical pharmacology study design and execution. -EXAMPLE RESPONSIBILITIES: With guidance, as a member of a drug development team, may provide input into product development strategies and/or research or clinical development plans for assigned products / projects.With guidance, may lead and manage design and conduct of clinical pharmacology studies of moderate complexity, which may include 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 study documentation, data analysis / management plans and scientific presentations or literature.Contributes to the preparation of documents for clinical and regulatory submissions.May represent 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 moderately complex obstacles within a clinical study and implements solutions.Must be able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.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 2+ years' relevant research or clinical experience and a PharmD or PhD in pharmaceutical sciences, pharmacology or related discipline with relevant research or clinical experience in the biopharma industry, healthcare, consulting, academia or a related environment.6+ years' relevant research or clinical experience and an MS in pharmaceutical sciences, pharmacology or related discipline with 6+ years' relevant research or clinical experience.8+ years' relevant research or clinical experience and a BS in pharmaceutical sciences, pharmacology or related discipline with 8+ years' relevant research or clinical experience.Relevant experience in [Enter disease / therapeutic area] is preferred. -Experience supporting clinical publications and presentations is 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.Proven analytical abilities as demonstrated through past experience and/or academic research.Has in-depth knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.Has significant knowledge of drug discovery and development, including study start-up, study management and monitoring, study close-out and reporting.Understands how clinical study design can lead to proof-of-concept.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.Knowledge of PK-PD modeling, analysis, software and scientific graphing.Demonstrates technical proficiency within the field of clinical pharmacology.Can provide effective input into clinical trial design, study concepts and protocols. -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 City; United States - New Jersey - ParsippanyType: Full time

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