Sr. Director-Clinical Research Physician Sub-team Leader

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Oversight of clinical planning, budgeting, and execution

• Participates in the adequate affiliate evaluation and input into clinical planning and contribution to clinical trials and communicates research needs to global Development team, Global Patient Outcomes/Real World Experience, and Pricing, Reimbursement and Access (PRA) teams to ensure Phase 3, 3b, and 4 clinical programs meet the needs of local/regional customers.

• Participates in the local clinical planning process for each brand team associated with the business unit/therapeutic area, to assure that plans are appropriately aligned with and support brand, affiliate, business unit, and company strategies and are completed on time for the annual business planning process.

• Assures that local clinical plans are coherent and not in conflict with those of Early Phase, Program Phase, and global Development team(s).

• Ensures medical team meets or exceeds commitments to Medical Affairs and Development teams for planned and agreed upon clinical research.

• Monitors progress toward implementation of the clinical research plans, and takes appropriate steps with the responsible clinical plans management and CRPs/CRSs if progress is not adequate.

• Monitors progress toward implementation of the other deliverables from the medical team (e.g., publications, field support), and take appropriate steps with the responsible cross-functional management team(s) if progress is not adequate.

• Responsible for generating, approving, and ensuring the implementation of local support in clinical research studies to meet the business unit's objectives within the resource capabilities.

• Ensures that clinical data generated for regulatory purposes meets all necessary regulatory standards.

• Provide support for global registrations, labeling and label modifications, and resolution of regulatory issues.

• Advisory committee participation as assigned.

Scientific and Technical Expertise

• Maintains his/her deep scientific, technical expertise and support, conducting activities in clinical research and commercialization support balanced with administrative activities as agreed upon by Sr. Director- Medical.

• Understand and keep updated with the pre-clinical, clinical pharmacology, and clinical data relevant to the team molecule.

• Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the team.

• Role model and functional member of the appropriate research, submission, registration, and commercialization support teams.

• Visibly active in his/her therapeutic area to maintain credibility with internal and external colleagues and the larger organization, as well as career satisfaction.

• Review and approve IIT proposals and publications, as requested by Sr. Director- Medical.

• Provide technical expertise, protocol development oversight, and input into Informed Consent Document (ICD) development.

Business/ customer support (pre and post launch)

• Ensures that medical team he/she supports is trained, and compliant with local, global, and company standards with regard to interactions with customers.

• In coordination with the Sr. Director- Medical, ensures that there is adequate scientific support for marketing and sales activities.

• Effective business partnering both internally and externally (including but not limited to marketing/sales, alliances, and joint ventures).

• Contribute to the development of medical strategies to support brand commercialization activities by working closely with brand teams, Global Patient Outcomes/Real World Experience and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan.

• Ensures team contributes as scientific and medical experts to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.

• Supports the negotiations for drug reimbursement with national health authorities as assigned by the Sr. Director- Medical.

• Contribute actively on an ongoing basis to the strategic planning for the brand.

• Ensures that medical team he/she supports is trained, and compliant with local, global, and company standards with regard to interactions with customers.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly