Director - Global GI Portfolio and Pipeline

Director Gi Portfolio And Pipeline

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Lilly depends on successful launches for multiple products across many therapeutic areas and geographies. Efficient launch preparation strategies and processes are critically important. The external environment is constantly evolving and continues to grow in complexity. Access to medicines and price / reimbursement has an increasingly higher level of importance and our health care professional (HCP) customers are demanding more real-world, evidence-based therapies and solutions. We must introduce ourselves to those and other customers in a way that establishes significant relationships, helps them understand the context and therapeutic value of our medicines and services, and prepares for their questions.

A successful launch requires competence in several specialized areas, including unlocking payer access and having effective commercialization plans in diverse health care ecosystems. The Director GI Portfolio and Pipeline will provide strong leadership and impact for the team on current GI marketed product and contribute work to the pipeline assets to deliver successful launches through individual contributions and through influence on the compound team that reports through MDU or Medical Affairs.

The Director GI Portfolio and Pipeline will facilitate planning and execution in conjunction with the commercial and clinical teams, which includes specific working groups (Marketing, Payer and Reimbursement Access, Medical Education, Medical Information, Advocacy and Professional Relations, Real World Evidence, Central Medical Capabilities and Scientific Data Disclosure). Director GI Portfolio and Pipeline collaborates across geographies with Medical Affairs teams in the US, ACE (Australia, Canada, and Europe), Japan, and the Emerging Markets, shaping the content through an ongoing dialogue with external thought leaders.

In close partnership with GPORWE and MDU functions, the Director GI Portfolio and Pipeline will participate in the planning and execution of coordinated evidence generation. Close collaboration will also be required with the Global Brand Development (GBD) Medical Director; Regional Therapeutic Area Medical Leaders; Affiliate Medical Directors, physicians, and scientists; and the Brand's commercialization and PRA leaders. The Director GI Portfolio and Pipeline will actively consult and contribute to the development of Phase 3 and NILEX studies and is accountable for the development and implementation of Global Phase 3B (not for registration) and Global Phase 4 studies.

The successful Medical Launch Indication will identify key themes for the successful launch of a new product and will articulate those themes across working groups and geographies, while also identifying and collaborating with the key external thought leaders who will influence the acceptance of the new product in the clinical community.

Primary Responsibilities

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Collaborate with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

The Primary Deliverables Of This Role Will Be :

Accountable for execution elements of branded product's annual medical plan under the mentorship of the GMA hub leader and GI TA lead as well as accountable for Global Medical Affairs launch and strategy, including responsibility for ensuring that the needs and education of payers, prescribers, and the other non-regulatory team members who influence patients' treatment access or benefits are met. Key activities include

• Development and execution of thought leader / key doer strategy
• Planning, development, and execution of Phase 3 and 3B through Phase 4 clinical research, RWE trials, ensuring the clinical program includes a robust comprehensive evidence package.
• Applying Next Generation Development into launch planning and execution
• Medical and disease state education, publications, medical information, and medical affairs advisory boards

Collaborate with GBD and affiliate / regional brand teams for launch preparation and serve as the primary medical leader for commercial-related activities, providing input for the following brand development activities.

Focus on product launches in the US and EU, and (as appropriate) Japan, Canada, Australia, China, and other key IBU countries. Serve as a resource and advocate for affiliates and regional medical affairs teams. Relay their needs back to the global team (including alliances). Be aware of and ensure that all medical affairs activities are in compliance with Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research, and that activities are aligned with the medical vision.

The Core Job Responsibilities Include The Following :

Launch Readiness Strategy

Leader With Vision Engagement

Clinical Planning

Business / Customer Support