Senior Director, Clinical Development- Inflammation/Fibrosis (MD)

Company: GILEAD Sciences
Location: Belmont
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 DescriptionSenior Director, Clinical Development- Inflammation/Fibrosis (MD)POSITION OVERVIEW: As Senior Director of Clinical development in the Inflammation/Fibrosis therapeutic area, you will play a leadership role in clinical development efforts for primary biliary cholangitis (PBC) at Gilead, with potential for opportunities in other indications in the portfolio, as well. You will join an active program with ongoing phase 3 and 4 studies and global regulatory filings underway or expected, becoming a key member of the Global Development Team. You will provide scientific and clinical leadership on activities including all aspects of clinical study planning, conduct, and read-out; lifecycle planning; scientific communication; regulatory filings; real world evidence strategies to support clinical programs; and efforts to advance value proposition for therapeutic agents meeting important unmet medical needs. The ideal candidate will have a strong scientific acumen; desire to work in fast-paced, matrixed environment; drive to expand his/her skillset as needed to meet team goals; ability to lead both strategic work as well as having high attention to detail; and track record of working collaboratively to achieve team goals.EXAMPLE RESPONSIBILITIES: Lead or oversee clinical trial protocol design, analysis planning, clinical study report development, and response to health authority inquiriesProvide scientific and clinical leadership or oversight in the preparation, review, and interpretation of clinical study data, ensuring high quality dataOversee or perform clinical study medical monitoring, including but not limited to assessment of eligibility criteria, addressing investigator questions, safety monitoring, and ensuring high data quality through data review as part of a cross-functional teamLead the development of the target product profile and clinical development plan for assigned molecules /productsContribute to global regulatory filing strategy and lead clinical development contributions in the preparation and review of regulatory documentsProvide scientific and clinical leadership or oversight in the preparation of investigator brochuresProvide scientific and clinical leadership to cross-functional teams including real world evidence and health economics and outcomes effortsPresent data at scientific conferences, clinical study investigator meetings, or to regulatory authorities, as neededAdhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPsREQUIREMENTS: 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 MD or equivalent with 6+ years clinical, scientific, and/or drug development experience in the biopharma industry, academia, or a related environmentBoard certification in hepatology or gastroenterology is preferred; however, other backgrounds including pulmonology, rheumatology, or other internal medicine background with experience in clinical research in chronic liver diseases, inflammation/fibrosis, autoimmunity and/or PBC/MASH also consideredExperience in the biopharma industry is preferred, with experience in medical monitoring and addressing medical concerns that arise during clinical studies, experience leading study concept and protocol design, and track-record of leading cross-functional projects or teamsExperience with regulatory filings, clinical publications, and scientific presentations to a range of audiencesDemonstrated excellence in a fast-paced environment, effectively managing multiple clinical project deliverables and priorities through matrix management and/or oversight of direct reportsKnowledge & Other Requirements Strong scientific acumen as demonstrated through past research track record, which may include academic researchCore expertise in the assigned or related disease areas, or strong desire to develop the necessary expertise to function effectivelyTrack record of independently leading clinical development deliverables for one or more projectsThorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical studiesStrong oral and written communication skillsOrganized and self-motivatedCollaborative work style with strong interpersonal skillsStrong desire to develop new expertise and learn new in new areas to accomplish team goals and advance professional development within the biopharma industryAbility to travel when neededThe salary range for this position is: $302,005.00 - $390,830.00. 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

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