Job Details

Sr. Director, U.S. Medical Affairs (Ethics and Compliance)

United States - New Jersey - Parsippany, United States - California - Foster City Legal & Compliance Regular

Job Description

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

Sr. Director, U.S. Medical Affairs

Ethics and Compliance Advisor to US Medical Affairs. This position reports to the Executive Director, U.S. Ethics & Compliance Advisor.

Essential Duties and Job Functions:

• Act as the key point of ethics and compliance support for relevant US Medical Affairs activities.
• Partner with leaders across Legal, Commercial, Medical, Clinical Development to build and integrate the compliance program into the US Medical Organization.
• Advise and provide guidance on Ethical Medical-Commercial interactions.
• Participate in activity reviews consistent with established policies and processes, advising on ethics and compliance insights and recommendations, including outreach to relevant stakeholders or subject matter experts when appropriate.
• Advise on and support the business and other key stakeholders in operationalizing compliance processes and executing within legal and compliance-related requirements.
• Deliver trainings and educational sessions to enhance ethics and compliance understanding among stakeholders.
• Partner as needed with Privacy and Data Ethics team to operationalize requirements related to data privacy, information security, cyber laws, industry codes.
• Support compliance-related incident response processes with internal stakeholders.
• Support and facilitate policy, training and communications, monitoring, risk assessments, due diligence, transparency, and other healthcare compliance needs.
• Stay abreast of relevant ethics and compliance developments and industry trends. Work in partnership with the Global Business Legal org and other compliance teams to help ensure the organization operates within ethical and compliance frameworks.
• Lead, inspire, and develop the team, fostering a high-performance culture. Provide mentorship, guidance, and professional development opportunities to enhance the team's capabilities and effectiveness.

Requirements

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

• Bachelor's degree is required. A Juris Doctorate or fully qualified legal credentials in one or more geographies of operations is preferred but not required.
• Extensive professional experience in-house in biotech, pharmaceuticals or other highly regulated industries or law firm advising in all relevant areas of practice for these industries. Ideally the majority of the years of career spent in-house.
• 14+ years of experience, with a BA/BS degree or 12+ years of experience, with an MS/MA or MBA, or PhD.
• Management experience and ability to mentor and supervise a team of professionals.
• Excellent verbal and written communication skills in English.

Knowledge, Experience and Skills:

• Knowledge and experience in practices related to interactions between commercial, medical affairs and market access.
• Invest time and effort in building strong relationships with relevant stakeholders. Act as a trusted advisor and cultivate a collaborative environment based on mutual respect and understanding.
• Approach challenges with a problem-solving mindset.
• Work together with colleagues across Legal and Ethics and Compliance teams to find ethical and compliant solutions.
• Cultivate and display the ethics and values for which Gilead strives, and actively engage with stakeholders from a place of trust and partnership. Be firm when needed, even when working with more senior stakeholders.
• Apply a deep understanding of the biopharma industry, Gilead's business objectives, and the specific challenges faced by different departments. This will enable the legal and compliance team to provide tailored and practical advice.
• Respond promptly to inquiries, requests, or concerns raised by business stakeholders. Demonstrate a sense of urgency in addressing their needs and provide timely feedback.
• Foster open and transparent communication channels with business stakeholders. Clearly communicate requirements, explain the rationale behind decisions, and provide regular updates on relevant changes or developments.
• Continuously evaluate and improve internal processes to ensure efficiency and effectiveness in supporting the business in achieving company goals. Minimize unnecessary bureaucracy and simplify workflows to facilitate smooth interactions.
• Embrace a culture of continuous improvement. Actively seek feedback from business stakeholders and strive to enhance the quality and effectiveness of support provided.