Eli Lilly and Company · 1 month ago
Sr. Director - Clinical Development
US, Indianapolis IN
Full-time
Onsite
Director/Executive
$198K/yr - $356K/yrEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to discovering life-changing medicines. The Sr. Director - Clinical Development will support early and late phase clinical trials in the gastroenterology therapeutic area, ensuring compliance with regulations and contributing to clinical strategy and execution.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design
Contribute to business unit and global alignment of clinical strategy and clinical plans
Understand and keep updated with the pre-clinical and clinical data relevant to the molecule
Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed upon project timeline
Provide protocol oversight and input into informed consent documents
Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions)
Review and approve risk profiles to ensure to ensure appropriate communication of risk to study subjects
Participate in investigator identification and selection, in conjunction with clinical teams
Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements
Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel
Serve as resource to clinical operations/CTMs/ clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study
Understand and actively address the scientific information needs of all investigators and personnel
Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures
Review lIT proposals and publications, as requested by Director-Medical
Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals
Understand and address the unsolicited scientific information needs of external health care professionals according to guidelines above
Participate in reporting of clinical trial data in Clinical Trial Registry activities
Support the planning of symposia, advisory board meetings, and other meetings with health care professionals
Support medical information associates in preparation and review of medical letters and other medical information materials
Prepare or review scientific information in response to customer questions or media requests
Provide telephone follow-up or specific written information requested by health care professionals as per global SOPs
Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts)
Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis
Develop and maintain appropriate collaborations and relationships with relevant professional societies
Support the design of customer research as medical expert
Support training of medical personnel, including geographic/affiliate medical personnel as assigned, medical and outcome liaisons and global patient outcomes personnel
Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events)
Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications
Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal
Provide medical expertise to regulatory scientists
Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective
Participate in advisory committees
Participate in risk management planning along with affiliates and Global Patient Safety (GPS)
Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans manager/project management associates and other cross-functional management during the development of the local business plan
Understand and anticipate the scientific information needs of all Development customers (payers, patients, health care providers)
Actively address Development customer (payer, patient, and health care providers) questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research efforts
Establish effective collaborations with marketing personnel in the various geographic regions to further corporate demand realization
Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts
Contribute as a scientific and medical expert 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
Support business-to-business and business-to-government activities as medical expert
Contribute actively on an ongoing basis to the strategic planning for the brand
By offering scientific and creative input, contribute to the development, review, and approval of promotional materials and tactics as needed
Become familiar with market archetypes and potential influence on the medical interventions for the product
Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become a patient advocate, as well as a medical expert
Participate in PhRMA or other local or national trade associations as appropriate
Support the management team, including the Sr. Director-Medical, in preparation and administration of the business unit development budget
Actively set and meet individual professional development goals and contribute to the development of others
Actively participate in recruitment, diversity and retention efforts
Collaborate proactively and productively with all alliance, business and vendor partners
Participate in active coaching by providing timely and constructive feedback to co-workers, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness
Participate in committees, Six Sigma initiatives and task forces as requested by local/corporate management
Ensures that at all times is adequately qualified and trained in the tasks required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self
Model the leadership behaviors
Be an ambassador of both patients and the Lilly Brand
Qualification
Required
Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. US trained physicians must have achieved board eligibility or certification
Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME)
Preferred
Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills
Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
Ability to engage in domestic and international travel to the degree appropriate to support the business of the team
Fluent in English, verbal and written communication
Benefits
Company-sponsored 401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
Founded in 1876
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
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