Associate Director, Clinical Development at Gilead Sciences

Tokyo, Japan

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Acts as the local scientific expert for assigned clinical research activities, addressing questions from internal functions and external Japanese physicians and research scientists
Works with Gilead Sciences Inc. (GSI) project teams including biostatisticians to prepare analyses to address specific questions as required
Drives assigned projects forward as Japan project team (JDT) lead with Japan cross functional team members
Interacts regularly with Global Development Team (GDT) Lead to exchange project information including strategic aspects and provides local requirements and needs to GDT Lead
Provides scientific support to Gilead functions including but not limited to GSI Clinical Development, Clinical Operations, Biostatistics, Data Management, Medical Writing, Clinical Pharmacology and Medical Affairs
Provides guidance to ensure scientific and clinical issues are addressed in a consistent manner
Identifies, establishes and maintains science-based relationships with Japanese therapeutic area experts to support Gilead’s development programs
Designs Japanese clinical studies including authoring of study concepts and protocol synopses
Works with the Clinical Operations team for the development, finalization and amendment (as applicable) of study protocols
Ensures scientific and clinical consistency across Japanese study protocols and with the global development programs
Retains overall responsibility for the scientific content and scientific integrity of clinical trials conducted in Japan
Proposes membership for ‘Trial Guidance and Publication Committees (TGPC)’ for review by GSI Clinical Development
Prepares specific sections of clinical study manuals, Investigator Meeting notebooks and other documents as needed
Contributes to the design and development of CRFs, Data Management Manuals and Data Analysis plans
Acts as the Study Director or Medical Monitor for assigned clinical studies in Japan
Prepares and presents (if applicable) scientific information concerning Gilead’s development programs internally and at external meetings as required
Prepares abstracts, posters and oral presentations of Gilead’s clinical trial and associated data

Responsibilities

Reporting to the therapeutic head in Clinical Development Japan
Playing an integral role in the scientific planning, execution and reporting of Japanese clinical studies for Gilead’s development compounds in inflammation and virology therapeutic area
Supporting local clinical development activities across development programs including oncology (although generally assigned to a specific therapeutic area)

Skills

Clinical Development

Clinical Research

Study Planning

Study Execution

Study Reporting

Inflammation

Virology

Oncology

Biostatistics

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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