Sr Associate Clinical Development Director (MD) Clinical Development Inflammation
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossibleFor Current Gilead Employees and Contractors:
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At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Clinical DevelopmentPOSITION 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.
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
Knowledge & Other Requirements
- 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.
- 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.
- 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: $230,860.00 - $298,760.00. 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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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com
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For Current Gilead Employees and Contractors:
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