Sr. Director, Clinical Development (MD)

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
 

As Sr. 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 therapeutic area with phase 3 and 4 PBC studies and global regulatory filings underway or expected, with potential for work across earlier phases, as well. You will provide scientific and clinical leadership on activities including clinical development plan generation; 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 your 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.

Responsibilities:

• Lead or oversee clinical trial protocol design, analysis planning, clinical study report development, and response to health authority inquiries

• Provide scientific and clinical leadership or oversight in the preparation, review, and interpretation of clinical study data, ensuring high quality data

• Oversee 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 team

• Lead the development of the target product profile and clinical development plan for assigned molecules /products considering both strategic and technical aspects

• Contribute to global regulatory filing strategy and lead clinical development contributions in the preparation and review of regulatory documents

• Provide scientific and clinical leadership or oversight in the preparation of investigator brochures

• Provide scientific and clinical leadership to cross-functional teams including real world evidence and health economics and outcomes efforts

• Present data at scientific conferences, clinical study investigator meetings, or to regulatory authorities, as needed

• Adhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs

Basic Qualifications:

• MD or equivalent with 6+ years clinical, scientific, and/or drug development experience in the biopharma industry, academia, or a related environment

Preferred Qualifications:

• Board certification in hepatology or gastroenterology is preferred; 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 considered

• Experience in the biopharma industry 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 teams

• Experience with regulatory filings, clinical publications, and scientific pre