Director, Medical Affairs Framework

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. 

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. 

The Director, USMA (United States Medical Affairs) Framework Architecture is responsible for establishing, maintaining and continuously improving the medical affairs framework within US Medical Affairs. This role ensures medical affairs operates ethically, transparently and in full compliance with internal policies, industry codes and regulatory requirements. This role oversees the design and implementation of robust medical mechanisms for medical content, scientific exchange, evidence generation and external engagement to uphold the highest ethical standards, patient-centricity, and scientific integrity.

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. Partner with patient safety organization. Ensure Scientific integrity in US Affiliate communication.

Contribute to shaping medical affairs framework that compliantly enables the US Medical Affairs and US Affiliate organization.

Key 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.

• Up to date on emerging global and U.S. regulatory, clinical, ethical and compliance trends and assess their impact on USMA framework.

• Act as key liaison between Medical Affairs, Regulatory, Legal, Compliance and Commercial teams to ensure medical affairs has the optimal framework to enable compliance and USMA deliverables.

• Oversee risk assessments and implement control measures for emerging issues and manage medical and scientific risks across the US Affiliate.

• Develop appropriate metrics and dashboards to reflect key performance indicators for effective Medical Affairs framework within the US.

Qualifications:

• BS/BA degree with 12+ years of experience or MS/MA degree with 10+ years of experience or PhD/PharmD with 8+ years of experience or MD with 4 years of experience

• Advanced degree in a life science discipline (MD, PharmD, or PhD strongly preferred).

• Minimum 5 years of experience in U.S. Medical Affairs roles within the pharmaceutical or biotech industry.

• Deep understanding of US FDA regulations, PhRMA Code, Sunshine Act, and other applicable laws and guidance.

• Proven understanding or ability to lead governance frameworks within a US-based, cross-functional Medical Affairs environment.

• Strong experience in promotional review committees and medical content governance.

• Exceptional interpersonal, influencing, and communication skills.

• Strategic mindset with the ability to navigate complex challenges and drive ethical, compliant decision-making.

People Leader Accountabilities: 

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. 
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. 
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. 

The salary range for this position is:

Other US Locations: $221,000.00 - $286,000.00.

 

Bay Area: $243,100.00 - $314,600.00.

Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.
 

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.