Senior Director Global Regulatory Lead (Early Phase) - Oncology

Purpose:

The purpose of the Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area. The GRL is the accountable decision maker for the development & execution of global regulatory strategies from portfolio entry to end of life cycle to ensure strategies meet global business objectives and regional/local affiliate requirements.

The GRL creates and leads the Global Regulatory Team and is responsible for forming and maintaining a highly effective global regulatory team. The GRL is responsible for the creation and maintenance of the regulatory strategy and ensures local plans, created by the regional regulatory teams, are aligned to the brand development/global program team and business priorities in terms of the program’s value proposition, workflow, product labeling, risk management, and issues management.

Accordingly, the GRL is the primary interface with, and will represent GRA on global brand development/program team to ensure global input into development plans, provide solutions (created with the regulatory team) to development and regulatory barriers, and reflect and manage risks. The GRL will represent regional regulatory plans to the GBD/global program team and at stakeholder/governance meetings and is responsible to include GRA functional and regional experts as needed to inform development and manage issues.

For preclinical and early clinical development programs, the GRL leads the US and Canada submissions and agency interactions. All other agency interactions will be the responsibility of the regional regulatory scientists.

Primary Responsibilities:

Regulatory and Scientific Expertise

Develop, Update and Execute the Global Regulatory Strategy - Initiate and Update Regulatory Strategy

• Obtain input from the global regulatory team members to develop a global regulatory strategy which supports product (including delivery device and relevant medical devices) development, registration, and lifecycle maintenance globally. Ensure regulatory strategy is integrated into the development team plan from Candidate Selection to End of Product Lifecyle (including NILEX). Develop and implement innovative approaches and solutions, and drive acceleration strategies. Identify and effectively communicate regulatory risks.
• Lead Global Regulatory Team in the development of regulatory strategy for assigned programs. Initiate and maintain regulatory strategy documents by leveraging team expertise, as well as scientific, drug/device clinical development and knowledge from health authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory science. Integrate information from the external environment, product specific regulator advice, and other public information (i.e. Advisory Committees) to develop robust, innovative regulatory strategies and solutions.
• Provide input for and attend key regulatory agency meetings, as needed, that could impact the global product strategy or brand.
• Enable discussion of the regulatory strategy document and regulatory issues/challenges at the Regulatory Strategy Forum together with Global Regulatory Team.
• Continually expand therapeutic area knowledge. Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment. Monitor upcoming and recent approvals of competitive development programs/plans.
• Ensure strategic messaging and content of global regulatory submission documents. Provide regulatory direction in the development of the core data sheet and claims mapping to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent.
• Ensures local strategies and solution deliver to the global regulatory strategy and meets business and brand goals.
• Provide timely and effective communication updates to the global brand development teams and business unit management and other internal stakeholders, as appropriate.

Lead Global Regulatory Team

• Lead Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications. Ensures clear and transparent two-way communication between global brand development/global program team and Global Regulatory Team.
• Coach and facilitate a feedback culture within the Global Regulatory Team to develop team performance.
• Communicate and share key information to enable seamless execution of global regulatory strategy and cross-functional shared learnings.

Represent Regulatory on the GBD/Global Program Team

• Support development teams in strategic planning, trial design and registration strategies for all in-scope countries for assigned products/programs, bringing in regional, CMC and Device regulatory scientists as needed.
• Consistently communicate well defined, successful regulatory strategies throughout the organization.
• For Preclinical and Early Clinical Development Programs: Lead and develop the US and Canada strategy for submission and amendments for IND, IDE, CTA
• Engage in, influence, and shape external environment initiatives related to portfolio assets
• Review corporate communications press releases

Lead/Influence/Partner

• Model the innovation, leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
• Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners.
• Constructively challenge teams to reach the best solutions to issues.
• Create and lead in an environment of equity and inclusion that encourages open discussions on issues to achieve a robust outcome on business decisions.
• Serve as a mentor for GRA personnel.
• May have direct reports.

Minimum Qualification Requirements:

• Advanced scientific degree (i.e., PhD, PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience

OR

• Bachelor’s with 10+ years of industry-related experience in regulatory affairs and/or drug development experience

Other Information/Additional Preferences:

• Oncology experience
• Experience in regulatory submissions and regulatory interactions in the US, EU, China and Japan
• Previous regulatory or leadership assignments across multiple countries
• Direct experience in clinical and CMC regulatory sciences
• Knowledge of Global regulatory procedures and practices and awareness of evolving regulatory reform initiatives desirable
• Demonstrated deep knowledge of the integrated drug development process and regulatory/business strategies
• Demonstrated ability to find solutions and alternatives through teamwork embracing diversity, equity and inclusion resulting in positive business outcomes
• Demonstrated ability to assess and handle risk in a highly regulated environment
• Strong written, spoken and presentation communication
• Demonstrated negotiation and influence skills
• Demonstrated attention to detail

Note: Preference is for this role to be Indianapolis-based, and may consider to be based at Stamford, CT or San Francisco, CA sites.

Anticipated travel of 10-15%