Sr Associate Clinical Development Director (MD) IBD/Inflammation

Job Description

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

POSITION OVERVIEW :

You will typically lead multiple components of clinical trial programs in IBD / inflammation clinical development. You may also act as the Physician Responsible on certain projects.

For the assigned projects, you are accountable for various aspects of ongoing clinical trial program-related activities.

These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.

EXAMPLE RESPONSIBILITIES :

• Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules / products.
• Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
• Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries.
• Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Manages the clinical development component(s) in the preparation / review of regulatory documents, investigator brochures and development plans.
• Coordinates the collection and assimilation of ongoing data for internal analysis and review.
• Coordinates and manages the preparation and / or review of data listings, summary tables, study results and scientific presentations.
• Presents scientific information at scientific conferences as well as clinical study investigator meetings.
• Adheres 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.

Minimum Education & Experience

• MD or equivalent with 2+ years’ clinical, scientific and / or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
• Board certification in gastroenterology is preferred, including familiarity with IBD management; alternatively, autoimmune disease training (e.

g. Rheumatology, Allergy / Immunology, or Dermatology)

• Experience in the biopharma industry is preferred but not required.
• Experience leading small cross-functional project teams in clinical research or development.
• Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations is preferred.
• Proven effectiveness managing clinical project deliverables through matrix management.
• Must be willing to relocate to Foster City campus or West coast based.

Knowledge & Other Requirements

• Demonstrated ability to be a fast learner.
• 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.
• Has advanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects.
• Strong communication and organizational skills.
• When needed, ability to travel.

The salary range for this position is : $237,660.00 - $307,560.00. 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*.