Director, Medical Affairs Framework at Gilead Sciences

Parsippany, New Jersey, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Up to date on emerging global and U.S. regulatory, clinical, ethical and compliance trends and assess their impact
Ability to partner with patient safety organization and ensure scientific integrity in US Affiliate communication
Capability to collaborate closely with U.S. Commercial, Regulatory, Legal, and Compliance teams

Responsibilities

Identify and share opportunities to improve specific Medical Affairs framework, policies and input into relevant global and local policies
Develop, lead, and continuously improve the U.S. Medical framework to support compliant medical operations and decision-making
Drive medical affairs framework and ethical training programs and ensure ongoing training within USMA and US Affiliate as required
Ensure appropriate onboarding of employees into USMA framework in collaboration with Global Learning and Development
Ensure an effective medical contribution to the review and approval processes for U.S. promotional and non-promotional materials, ensuring medical accuracy and compliance (PRC)
Ensure an effective medical contribution to the U.S. Medical Review Committee (MRC), ensuring timely and compliant review of medical content
Manage the USMA input into PRC and MRC escalation
Collaborate closely with U.S. Commercial, Regulatory, Legal, and Compliance teams to support business objectives while upholding medical affairs framework standards
Ensure adherence to U.S. regulatory and industry standards including FDA promotional guidelines, PhRMA Code, and OIG compliance requirements
Provide medical governance oversight for U.S. medical field activities (e.g., MSL engagements, scientific exchange, advisory boards, investigator-sponsored studies)
Support audits and inspections as needed
Establish, maintain and continuously improve the medical affairs framework within US Medical Affairs, ensuring ethical, transparent, and compliant operations
Oversee the design and implementation of robust medical mechanisms for medical content, scientific exchange, evidence generation and external engagement
Develop and execute training programs for Medical Affairs personnel on Medical Affairs framework and ethical standards, track training completion and maintain audit readiness documentation
Ensure USMA employees operate in the appropriate framework for all US medical activities, including publications, post approval studies, investigator-initiated research, advisory boards, scientific engagement and medical information and response documents
Contribute to shaping medical affairs framework that compliantly enables the US Medical Affairs and US Affiliate organization

Skills

Key technologies and capabilities for this role

Medical AffairsFramework ArchitectureComplianceRegulatory RequirementsEthical StandardsTraining ProgramsScientific ExchangeEvidence GenerationExternal EngagementAudit ReadinessPatient-CentricityScientific Integrity

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require office presence?

This information is not specified in the job description.

What are the key responsibilities for this role?

The role involves establishing and improving the medical affairs framework, developing training programs on ethical standards, ensuring compliance in medical activities, and partnering with patient safety and global organizations.

What is the company culture like at Gilead?

Gilead emphasizes collaboration, determination, a relentless drive to make a difference, and creating an inclusive environment where employees feel developed and empowered, with strong people leadership.

What makes a strong candidate for this Director role?

A strong candidate should have expertise in medical affairs frameworks, compliance, ethical standards, training program development, and the ability to lead improvements in medical operations within a pharmaceutical context.

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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