Associate Director, Clinical Development (MD)
United States - California - Foster City Clinical Development & Clinical Operations Regular
Job Description
Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. As an Associate Clinical Development Director (MD), you will typically lead one or more components of clinical trial programs in HIV treatment and cure clinical development. 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.
Responsibilities- Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
- Provides input into HIV study plans, 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.
Basic Qualifications- MD/DO or equivalent.
- 5 years of clinical, scientific and/or drug development experience, preferably in HIV, infectious diseases or immunology, and preferably in the biopharma industry, or a related environment.
- Demonstrated ability to be a fast learner and team player.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Proven analytical and written and oral communication abilities as demonstrated through past experience and/or academic research.
- Experience in scientific publications and presentations.
- Strong communication and organizational skills.
- When needed, ability to travel.
Preferred Qualifications- 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 major disease areas, as evidenced by effectiveness supporting clinical projects.
- Experience working with cross-functional teams and leading study concept and protocol design in clinical research or development.
- Experience supporting clinical study design, medical monitoring and regulatory filings.
- Experience supporting clinical publications and presentations.
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.
Gilead Core Values
- Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
The salary range for this position is: $210,375.00 - $272,250.00. 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: Gilead Benefits.
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.
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