Sr Director, Clinical Development- CAR-T (MD) 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

MD/DO and 6+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia
Board certification/specialization in hematology or oncology (preferred)
CAR-T therapeutic area experience (preferred)
Multiple myeloma disease area expertise, with experience managing Phase II or III studies in multiple myeloma CAR-T trials within the pharmaceutical industry (preferred)
Drug development experience, either within industry or as a clinical investigator/principal investigator (preferred)

Responsibilities

Provides ongoing medical monitoring for multiple clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance
Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice
Leads project teams to design and implement clinical studies
Writes protocols, investigator brochures, clinical study reports and reviews clinical trial documents
Conducts investigator meetings and leads site initiation visits with clinical trial investigators
Implements and deploys drug development strategic plans, develops contingency plans, provides technical and strategic advice, and meets milestones and budgets
Translates findings from research and nonclinical studies into clinical development opportunities
Interacts with clinical investigators and thought leaders
Works with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry, and ensures compliance with these external guidelines
Works with internal pre-clinical scientists, translational scientists, business and commercial organizations in a cross functional manner
Works in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs
Provides clinical expertise and input for regulatory filings (i.e., BLA, MAA) as well as response to questions from regulatory authorities in the context of IND submissions, clinical trial applications or filing procedures
Provides clinical guidance and works in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial)
May present scientific information at scientific conferences as well as clinical study investigator meetings. Where applicable, takes a lead on authoring scientific publications
May assist in the clinical evaluation of business development opportunities

Skills

Clinical Trials

Medical Monitoring

CAR-T Therapy

Good Clinical Practice

Protocol Writing

Investigator Brochures

Clinical Study Reports

Toxicity Management

Drug Safety Surveillance

Regulatory Compliance

Project Leadership

Site Initiation Visits

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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