US Medical Senior Director, Medical Affairs Evidence Generation at Gilead Sciences

Santa Monica, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, OncologyIndustries

Requirements

Experienced clinical leader with extensive therapeutic expertise
Proven track record in collaborative trial design and management
Passion for transforming patient outcomes

Responsibilities

Serve as a senior member of the Evidence Generation (EG) leadership team, co-driving the evolution of Kite’s US evidence generation strategy and value proposition
Support the development and execution of the Integrated Evidence Plan (IEP) for Kite assets in collaboration with the entire Evidence Generation Function, Global Medical Affairs Strategy and Product Teams
Provide leadership to support the identification of critical evidence gaps and define the most appropriate research approaches (e.g., retrospective, prospective, interventional, RWE) to address the unmet needs
Provide scientific and medical oversight for all Medical Affairs / Kite Sponsored Studies including interventional trials, non-interventional studies, and US Strategic Alliances
Lead the development of clinical study concepts, protocols in collaboration with Medical and Clinical development teams
Oversee the US Investigator-Sponsored Research (ISR) and Collaborative Research (CR) program within the evidence generation strategy, ensuring scientific merit, alignment with strategic priorities, and compliance
Serve as the Medical Monitor for assigned evidence generation studies, ensuring timely execution, data quality, and compliance with all relevant regulations (GCP, internal SOPs)
Provide strategic oversight and clinical guidance to operational teams to ensure timely and impactful execution
Lead the medical review, interpretation, and communication of study results, including drafting publications, abstracts, posters, and internal/external presentations
Serve as a medical expert for study data, engaging with internal and external stakeholders and external Key Opinion Leaders (KOLs)
Collaborate with Global Medical Strategy to ensure accurate and compliant dissemination of generated evidence
Partner across Kite Medical Affairs, Clinical Development, Translational Medicine, Regulatory Affairs, and Product Teams to build integrated cross-functional capabilities
Mentor and provide guidance to team members and cross-functional partners on evidence generation best practices, methodologies, and compliance requirements
Ensure all evidence generation activities are conducted in strict compliance with regulations and standards

Skills

Evidence Generation

Integrated Evidence Plan

Clinical Trial Design

Strategic Planning

Cell Therapy

CAR T-cell Therapy

Medical Affairs

Therapeutic Expertise

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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