Senior Director, Clinical Research Policy (Hybrid)

Job Description

The Science and Regulatory Policy (SRP) team advocates for policy priorities that support the pipeline and portfolio for our Research & Development Division and our company’s business goals, developing wider support for our causes and maintaining a strong reputation as a science-led biopharmaceutical innovative leader.  We work in partnership with all of the our Research & Development Division divisions to define and implement a prioritized policy and advocacy plan that advances business goals.

The SRP team comprises of four contributing teams:

• Global Regulatory Policy (GRP)

• Data & Advanced Digital Technology Policy (DADTP)

• Evidence Policy, and

• Clinical Research Policy.

Our SRP team responsibilities include:

• Developing and delivering strategic leadership for policy priorities to support our pipeline and portfolio;

• Advocating for and anticipating policy change that affects our research and development activities worldwide and innovation environment;

• Advising and providing insights for our Research & Development Division senior leadership on critical developments in the global policy environment that impact our pipeline and portfolio;

• Taking leadership for coordinating and aligning policy development and activity across our Research & Development Division, with particularly focus on the Development and Regulatory organizations;

• Leadership for strategy and coordination of our Research & Development Division External Policy relationships to meet priorities;

• Building our company’s share of voice and influence extramurally to support the company enterprise policy agenda.

Responsibilities and activities of the Senior Director, Clinical Research Policy

include:

• Leads and is responsible for the Company’s Clinical Research Policy and Intelligence operations globally,

• Provides leadership and strategic direction to the Clinical Research Policy team,

• Establishes and drives the clinical research policy priority agenda for the Company and oversees the surveillance and regulatory intelligence measures,

• Supports the Development leadership team advising Development leadership on global clinical research policy issues,

• Serving as a strong subject matter expert in regulations and laws that shape clinical research environments in the United States, including Good Clinical Practice (GCP) and related international standards.

• Proactively monitoring and interpreting the external clinical research environment in the United States to provide a strategic view of emerging issues and identify opportunities to influence the environment favorably for company business and the product portfolio. 

• Engaging with key company stakeholders to develop, shape and ensure alignment with the overall company position to respond to upcoming legislation, guidance, and regulatory processes applying to clinical evidence development. 

• Working closely with subject matter experts within the company to assess the impact of clinical research policy on the company’s products and goals.

• Supporting the team responsible for clinical research policy surveillance and advocacy.

• Driving and shaping policy initiatives and external networking opportunities to maximize the positive impact of the company in the clinical research environment.  

• Representing the company on key advocacy topics and maintaining productive relationships with industry staff, health authorities and NGOs.

• Collaborating closely with all SRP teams, Global Public Policy, Federal Policy, Office of Ethics, Clinical Transparency and other key stakeholders within the company on the development and implementation of clinical research policy goals.

• Working closely with the Global Regulatory Policy team to align on clinical research policy efforts in the regions and therapeutic area requirements.

Education minimum required:

• Bachelor’s degree is required, preferably in science, health care, public health or health policy or BS in any field accompanied by a master’s or doctorate degree in science, health care, public health, health policy, or law

• Doctorate degree and at least 5 years’ experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority) and preferably in clinical research activities OR

• Master’s degree and at least 8 years’ experience with FDA or other health authority, either directory (wor