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 outside of initial job description
May travel up to 25%
People Leader Accountabilities:
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
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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