Associate Director (MD), Clinical Development

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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.
 

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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 cert