Senior Director, Medical Affairs Framework

Gilead Sciences•Parsippany, NJ

17h

About The Position

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 Senior 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 exchange 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.

Requirements

BS/BA degree with 14+ years of experience or MS/MA degree with 12+ 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.

Nice To Haves

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.

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.