Sr Director Clinical Development MD

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

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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 readout; 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 fastpaced 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 crossfunctional 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 crossfunctional 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 trackrecord of leading crossfunctional projects or teams

• Experience with regulatory filings clinical publications and scientific presentations to a range of audiences

• Demonstrated excellence in a fastpaced environment effectively managing multiple clinical project deliverables and priorities through matrix management and/or oversight of direct reports

• Strong scientific acumen as demonstrated through past research track record which may include academic research

• Core expertise in the assigned or related disease areas or strong desire to develop the necessary expertise to function effectively

• Track record of independently leading clinical development deliverables for one or more projects

• Thorough understanding of pharmaceutical regulatory requirements and impact on development and of clinical studies

• Strong oral and written communication skills

• Organized and selfmotivated

• Collaborative work style with strong interpersonal skills

• Strong desire to develop new expertise and learn new in new areas to accomplish team goals and advance professional development within the biopharma industry

• Ability to travel when needed

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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