Associate Director (MD), Clinical Development

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Job Description

Associate Director (MD), Clinical Development

As Associate Director of Clinical Development, you will typically lead one or more components of clinical trial programs in the inflammation and fibrosis therapeutic area, including work on seladelpar for primary biliary cholangitis (PBC). You will be accountable for various aspects of ongoing clinical trial and related activities. These activities include, but are not limited to, study protocol preparation, medical monitoring, investigator communication, contributions to data analysis plans, study reporting, clinical development inputs into regulatory documentation, and contribution to publications and scientific presentations. Scope may include phase 3 and 4 studies with an opportunity to contribute across studies of other phases, as appropriate. The ideal candidate will have a strong scientific acumen; desire to work in fast-paced, matrixed environment; and drive to expand his/her skillset as needed to meet team goals.

EXAMPLE RESPONSIBILITIES:

• Provide scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines
• Provide input into clinical trial protocol design, clinical study reports and health authority inquiries
• Provide ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance
• Manage the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans
• Coordinate the collection and assimilation of ongoing data for internal analysis and review
• Coordinate and manage the preparation and/or review of data listings, summary tables, study results and scientific presentations
• Present scientific information at scientific conferences as well as clinical study investigator meetings
• Adhere 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.

Basic Qualifications:

• MD or equivalent with clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment
• Doctorate and 5+ years of relevant experience will be considered

Preferred Qualifications:

• Board certification hepatology, gastroenterology preferred, however, other backgrounds including pulmonology, rheumatology, or other medical background with experience performing clinical research studies in chronic liver diseases, inflammation/fibrosis, autoimmunity and/or PBC/MASH also considered
• Experience in the biopharma industry
• Experience working on and with cross-functional project / program teams in clinical research or development
• Experience supporting clinical study design, medical monitoring, and regulatory filings
• Experience supporting clinical publications and presentations

Other Requirements:

• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed
• Proven analytical abilities as demonstrated through past experience and/or academic research
• Understands drug development phases and the nature of associated clinical trials across phases
• Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures
• Strong communication and organizational skills, organized and self-motivated
• Strong desire to develop new expertise and learn new in new areas as needed to accomplish team goals and advance professional development within the biopharma industry
• Ability to travel when needed

Compensation

The salary range for this position is: $226,185.00 - $292,710.00. 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.

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