For Current Gilead Employees and Contractors:
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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 development. 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.
- May serve as Early Development Leader (EDL) for one or more 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.
- May provide ongoing clinical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- 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.
- Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures, 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.
- 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- PharmD or PhD in clinical research or clinical pharmacology or other relevant field with 8+ years' scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
- MS with 10+ years' relevant scientific and/or drug development experience.
- BS or RN with 12+ years' relevant scientific and/or drug development experience.
- Experience in oncology clinical 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 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 a 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: $237,660.00 - $307,560.00.
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