Senior Director, Clinical Research Policy (Hybrid)

$164,800 - $259,400/Yr

Merck & Co. - Rockville, MD

Full-time - Senior

Onsite - Rockville, MD

Chemical Manufacturing

About the position

The Senior Director, Clinical Research Policy is responsible for leading the Clinical Research Policy and Intelligence operations globally within the Science and Regulatory Policy (SRP) team. This role involves developing and implementing strategic policy priorities that support the company's research and development goals, advocating for policy changes, and providing insights to senior leadership on critical developments in the global policy environment. The position requires collaboration with various stakeholders to ensure alignment on clinical research policy initiatives and to influence the external clinical research environment favorably for the company's business and product portfolio.

Responsibilities

• Lead and manage the Company's Clinical Research Policy and Intelligence operations globally.
• Establish and drive the clinical research policy priority agenda for the Company.
• Oversee surveillance and regulatory intelligence measures related to clinical research policy.
• Advise Development leadership on global clinical research policy issues.
• Monitor and interpret the external clinical research environment in the United States.
• Engage with key stakeholders to align on the company's position regarding legislation and regulatory processes.
• Collaborate with subject matter experts to assess the impact of clinical research policy on products and goals.
• Drive policy initiatives and external networking opportunities to maximize the company's impact in the clinical research environment.
• Represent the company on key advocacy topics and maintain relationships with industry staff, health authorities, and NGOs.
• Work closely with all SRP teams and other key stakeholders on clinical research policy goals.

Requirements

• Bachelor's degree in science, health care, public health, health policy, or a related field; advanced degrees preferred.
• Doctorate degree with at least 5 years of experience with FDA or other health authority, or a Master's degree with at least 8 years of experience, or a Bachelor's degree with at least 10 years of experience in clinical research activities.
• Experience managing teams, projects, or programs, and directing resource allocation.
• Proven capability as a credible and influential spokesperson.
• Deep understanding of the US clinical research environment and related regulations.
• Strong relationship management and interpersonal skills with excellent communication abilities.
• Proven success in stakeholder engagement across organizational levels.
• Ability to thrive in a cross-functional team environment with a global mindset.
• Willingness to travel internationally on a quarterly basis.

Nice-to-haves

• Experience with Good Clinical Practice (GCP) and related international standards.
• Knowledge of intelligence tools and methods related to clinical research.

Benefits

• Bonus eligibility
• Long-term incentive if applicable
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays
• Vacation
• Sick days