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
 

Here at Gilead, we are passionate about developing more effective medicines for patients suffering with rheumatological diseases. We are looking for a highly motivated individual who shares this passion and wants to join our team as Medical director, Clinical Development (MD), to help drive us towards our goals.

Responsibilities

• Provide clinical oversight and medical monitoring to one or more clinical trials

• Lead project teams to design and implement clinical studies

• Document writing and review – Including but not limited to, protocols, investigator brochures, clinical study reports and other clinical trial documents

• Conduct investigator meetings and lead site initiation visits with clinical trial investigators

• Implement and deploy drug development strategic plans and meet milestones

• Translate findings from research and nonclinical studies into clinical development opportunities

• Interact with clinical investigators and thought leaders

• Work closely in a team with key cross functional partners including regulatory affairs, patient safety, clinical operations, biostatistics, clinical pharmacology, research/ biology

• Provide clinical expertise and input for regulatory filings (i.e., BLA, MAA) as well as response to questions from regulatory authorities in the context of IND submissions, clinical trial applications or filing procedures

• Lead internal safety review meetings for trials

• Provide clinical guidance and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial)

• May present scientific information at scientific conferences as well as clinical study investigator meetings.

• Lead on authoring scientific publications and presentations

• May assist in the clinical evaluation of business development opportunities

Basic Qualifications

• MD 4+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia

• Clinical or scientific experience in rheumatology, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience such as medical affairs

Preferred Qualifications

• Board certification/specialization in rheumatology

• Experience managing phase 1-3 trials

• Demonstrated clinical development strategist with experience designing, implementing and conducting clinical trials, with emphasis on late study trial designs. 

• Experience in regulatory interactions in late-stage clinical drug development is preferred, e.g., interactions regarding pivotal trial designs, primary analysis, BLA, sBLA, etc. 

• Strategic leadership and tactical skills, excellent initiative, and judgment

• Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators

• Demonstrated ability to work well in teams in a cross functional manner

• Ability to communicate and work in a self-guided manner with scientific/technical personnel

• Ability to think critically, and demonstrated troubleshooting and problem-solving skills

• Self-motivated and willing to accept responsibilities