Associate Director/Director, Clinical Development (MD) at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

MD or equivalent
2+ years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment
Experience in phase 1 and 2 clinical trials is preferred
Board certification in rheumatology/dermatology (preferred, based on description)

Responsibilities

Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules/products
Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical 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, investigator brochures and development plans
Coordinates the collection and assimilation of ongoing data for internal analysis and review
Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations
Presents scientific information at scientific conferences as well as clinical study investigator meetings
Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs
Leads multiple components of clinical trial programs in immunology clinical development
Acts as the Physician Responsible on certain projects
Accountable for study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations

Skills

Key technologies and capabilities for this role

Clinical DevelopmentImmunologyClinical TrialsStudy Protocol PreparationInvestigator DocumentationPhysician Oversight

Questions & Answers

Common questions about this position

Is this a remote role or does it require office presence?

This is a site-based role at Gilead's global headquarters in Foster City, CA, with a hybrid environment offering the option to work from home on Mondays and Fridays.

What are the main responsibilities of this role?

The role involves leading components of clinical trial programs in immunology, including study protocol preparation, medical monitoring, protocol design, clinical study reports, and providing scientific guidance to cross-functional teams.

What is the salary or compensation for this position?

This information is not specified in the job description.

What is the company culture like at Gilead?

Gilead emphasizes values of integrity, inclusion, teamwork, and excellence, with a focus on collaboration, determination, and empowering employees through great leadership to create an inclusive environment where everyone feels developed.

What qualifications make a strong candidate for this role?

Strong candidates will have an MD degree, experience leading clinical trial programs in immunology, expertise in clinical development activities like protocol design and medical monitoring, and the ability to provide scientific guidance to cross-functional teams.

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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