Associate Director, Clinical Pharmacology - Oncology

Associate Director, Clinical Pharmacology - Oncology United States - California - Foster CityUnited States - New Jersey - Parsippany Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. Making an impact on a global scale Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly CreatingPossible 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 Description Associate Director, Clinical Pharmacology - Oncology 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 strategy and clinical pharmacology studies in Oncology with a focus on combinations involving IO agents, ADCs etc 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. EXAMPLE 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 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. 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. Minimum Education & Experience PharmD or PhD in pharmaceutical sciences, pharmacology or related discipline with 5 years' relevant research or clinical experience. Relevant experience in Oncology therapeutic area 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. Experience supporting clinical publications and presentations is strongly 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. 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 skills. When needed, ability to travel. The salary range for this position is: $177,905.00 - $230,230.00. 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: https://www.gilead.com/careers/compensation-benefits-and-wellbeing 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 ApplicantAccommodationsgilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our 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. jeid-cb071b8b7f07c84c8a9d234c2d1fc91c