Sr. Director, Clinical Development (MD)- Inflammation/Fibrosis Therapeutic Area

Getting Hired; Foster City (CA); On-site; USD 302,000 - 391,000; Full time

Job summary

A leading biopharmaceutical company in California is seeking a Sr. Director of Clinical Development to lead efforts on clinical development for primary biliary cholangitis (PBC). Candidates should have an MD, 6+ years of experience in the biopharma industry, and a strong scientific acumen. This role offers competitive compensation and a comprehensive benefits package.

Benefits

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Company-sponsored medical, dental, vision, and life insurance plans

Qualifications

• 6+ years of clinical, scientific, or drug development experience in the biopharma industry or academia.
• Strong desire to work in a fast-paced environment.
• Ability to lead strategic tasks while focusing on details.

Responsibilities

• Lead clinical trial protocol design and oversight.
• Ensure high quality data from clinical studies.
• Contribute to global regulatory filing strategy.

Skills

Scientific acumen

Leadership skills

Communication skills

Organizational skills

Collaborative work style

Education

MD or equivalent

Job description

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. 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.

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.

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 presentations to a range of audiences

• Demonstrated excellence in a fast-paced 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 execution of clinical studies

• Strong oral and written communication skills

• Organized and self-motivated

• 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

The 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 the following:

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: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 [e-mail] for assistance.

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