Director, Clinical Development Oncology (MD)
Locations: United States - California - Foster City
Time Type: Full time
Posted on: Vor 16 Tagen ausgeschrieben
Job Requisition ID: R0042633
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 fulfill their aspirations. Join Gilead and help create possible, together.
Job Description
You will typically be a critical member (or leader) of Early Development Teams and lead multiple clinical development components of programs in Oncology Early clinical development. You may also act as the Physician Responsible on certain projects. These activities include, but are not limited to, clinical study design and protocol preparation, additional study or investigator documentation, contributions to data analysis plans, ongoing data interpretation, study reporting, and clinical development inputs into regulatory documentation, publications, and scientific presentations.
EXAMPLE RESPONSIBILITIES:
- Provides input into or leads the development of the Clinical Development Plan and success criteria for assigned molecules as appropriate for early development programs.
- Provides scientific and clinical guidance to cross-functional teams and colleagues to meet early 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, including urgent information requests, investigator brochures, clinical study reports, and development plans.
- Coordinates the collection and analysis of ongoing data for internal analysis and review and ensures appropriate data cleaning and integrity.
- Coordinates and manages the preparation and/or review of data listings, summary tables, study results, and scientific presentations.
- Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings.
- Develops manuscripts for publication in peer-reviewed journals.
- Presents scientific information to clinical study investigators at appropriate meetings and to governance committees (e.g., DRC).
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
- Provides oncology clinical guidance to Research (including Biology, Toxicology), Clinical Operations, Biomarkers, Clinical Pharmacology, Biometrics, Patient Safety, Regulatory, and Project Management staff.
- Frequent, direct contact with study sites and investigators.
- Supports or leads regular safety calls and SRT meetings.
- Assists in the clinical evaluation of business development opportunities.
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 4+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment.
- Board certification in Medical Oncology and/or Hematology is preferred, including familiarity with clinical diagnosis and management of patients with cancer.
- Experience in oncology drug development, especially early clinical development.
- Significant experience working on, with, and leading cross-functional project/program teams in life sciences, healthcare, consulting, or academia.
- Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications, and presentations.
- Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.
Knowledge & Other Requirements
- Proven analytical and strategic abilities as demonstrated through past experience and/or academic research.
- Has core expertise in the assigned or related disease area, as evidenced by the ability to independently lead clinical development for deliverables for one or more projects.
- Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
- Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees.
- Strong leadership skills with an ability to set vision, lead change, and mentor others.
- Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.
- Excellent scientific written and oral communication skills.
- Facility with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results.
- Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality.
- Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20-30% travel expected).
The salary range for this position is: $255,425.00 - $330,550.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. 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.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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