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.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Purpose:
The Clinical Design function was created to establish study design as a core capability, with tightly integrated cross-functional experts providing innovative, high quality study designs that transition seamlessly to execution. The purpose of the Director - Clinical Design Physician – Cardiometabolic Health role is to provide Medical leadership within the group. The Physician must have deep understanding of the biopharmaceutical industry, drug development, Diabetes-associated comorbidities, clinical research, and clinical study design.
Through application of Industry training, clinical expertise, and relevant experience, the Director - Clinical Design Physician – Cardiometabolic Health plays a key role in the development of program and trial design options and translation into high quality clinical trial protocols. While Clinical Design’s main focus is on proof of concept and registration clinical studies, the role may work on trials across early and/or late phases of development and commercialization of the product. The Clinical Design Physician may participate in the authoring and/or review process for publications and as needed works with regulatory and other governmental agencies. They will participate, at times, in activities largely led by Asset Teams, such as outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization.
Primary Responsibilities
The primary responsibilities of the Director - Clinical Design Physician – Cardiometabolic Health are generally related to phase II (proof of concept) to III (registration) studies in patients with commonly occurring cardiometabolic disease states (e.g. obesity, cardiovascular disease, renal and hepatic complications, and women's health comorbidities). The core job responsibilities typically include those listed below as well as all other duties as assigned.
_Clinical Plan Options and Clinical Trial Protocols _
- As the Medical leader on a cross-functional Clinical Design team, translate therapeutic area and asset team strategy into clear objectives and associated clinical development program and trial optionality. Optionality will address business and customer needs (patient, prescriber, payer, and/or regulator); be in alignment with phase of product lifecycle; and clearly articulate associated tradeoffs in value (information gathered, risks created/discharged, cost, and time).
- Represent program and trial design optionality to asset teams and Sr. Leaders to inform prioritization of an option that will be translated into a clinical protocol(s). Adjust optionality in accordance with feedback from leadership.
- Develop study protocols in collaboration with the Design Team and partners in the Lilly Cardiometabolic Health Business Unit Development Team, Discovery, Program Phase Medicine, and Clinical Pharmacology.
- Provide insight into impact of study/protocol design features to execution speed/efficiency.
- Contribute to the development of asset strategy (e.g. identification of target patient population) in partnership with the asset team.
- Contribute to business unit and global alignment of portfolio clinical strategy and the associated asset-specific clinical plans.
Clinical Research/Trial Packages, Execution and Support
- Collaborate with clinical research staff in the design and conduct clinical trials (e.g. sample size, patient commitment, timelines, grants, and governance review interactions).
- Champion key strategic initiatives, such as decentralized clinical trials and diversity/equity/inclusion in clinical research. Understand how design elements influence the ability to deliver on these initiatives and influence adoption of designs that enable their success.
- Review risk profiles to ensure appropriate communication of risk to study subjects.
- Participate in investigator identification and selection, in conjunction with Clinical Design and clinical teams.
- Actively participate in subject recruitment, diversity, and retention efforts.
- Support seamless transition of protocols from design to execution.
Scientific Data Dissemination/Exchange
- 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.
- Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on an international basis.
- Develop and maintain appropriate collaborations and relationships with relevant professional societies.
- Participate in development of scientific data dissemination, and preparation of final reports and publications.
Scientific / Technical Expertise
- 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 product.
- Be aware of current trends and projections for clinical research, and practice, and access in the therapeutic area(s) relevant to the product.
- Engage appropriately with the asset teams on relevant external activities to have good understanding of their patients, medical and payer communities, and business strategy.
Shared Learning
- Focus on organizational learning to identify best practices, delivering these as systemized standard approaches with ultimate goal to make program and protocol design streamlined, less burdensome, faster, and less expensive.
- Closely collaborate with asset teams and execution teams to understand the impact of design on speed to protocol approval and study startup. Work over time with other Clinical Design staff to analyze experience and improve approaches.
- Work closely with counterparts in Clinical Design and therapeutic areas to continue to evolve Lilly standards, tools, and best practices that span drug development.
- Provide clinical leadership in collaboration with other Clinical Design members in appropriate development of standardized/simplified processes, templates, and tools.
Minimum Requirements:
- 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.
- U.S. trained physicians must have achieved board eligibility or certification.
- Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.
- Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
- Pharmaceutical Industry experience in of at least three years and adequate to provide strong grounding in the drug development progress, clinical trial principles, and scientific decision-making.
- Experience of a minimum of 3 years in multiple areas relevant to clinical trial design (e.g., statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, decentralized clinical trials).
Additional Preferences:
- Clinical trial design leadership in at least one key in scope development phase (proof of concept, dose ranging, registration, and/or phase 3b/4 studies).
- Board certification or eligibility within a specialty directly relevant to comorbidities of Diabetes (e.g. cardiology, obesity medicine, nephrology, hepatology) strongly preferred
- Clinical research experience in one or more comorbidities of Diabetes.
- Strong understanding of relevant comorbidities of Diabetes – pathology, pathophysiology, unmet needs, and treatment standards.
- Strong interpersonal, organizational, and negotiation skills.
- Ability to influence others (both cross-functionally and within the function) to advance business strategies and objectives.
- Excellent teamwork skills.
- Fluent in English, with strong communication skills, verbal and written.
- Drug development experience spanning all core relevant phases (proof of concept through registration).
- Understanding of how design elements translate into delivery. Bias for simplifying, reducing burden, and creation of value through excellent design.
- Strong communication skills demonstrated in a variety of modalities (e.g. presentations, meetings, creation of protocols and regulatory documents) and with broad set of stakeholders (e.g. team leaders, Sr. Leader decision makers, medical and non-medical counterparts, thought leaders, investigators, regulators).
- Bias for action.
- Desire to influence a broad portfolio across phases through exceptional clinical plan optionality and study design.
- MBA or similarly relevant training in the business of life sciences.
- Strong foundation in statistical science, including Bayesian statistics, as applied to study design (e.g. sample size determination, setting of critical success factors). Ability to communicate effectively with statisticians and help translate complex principles to inform design optionality and protocols.
- Willing to relocate to Indianapolis.
- If unable to relocate, demonstrated ability to work with high effectiveness from a remote location in a hybrid environment. Willing to travel for business critical events, teambuilding, and to develop a strong internal network.
- Willing to engage in limited domestic and international travel to the degree appropriate to support the business of the team.
OTHER INFORMATION
Primary internal interactions
- Clinical Design teammates and leadership
- Clinical planning, operations, CRPs/Ss, other research staff
- Team leaders and COOs
- Sr. Leaders within Clinical, R&D, therapeutic areas, and business units
- Statisticians
- Scientific communication associates
- Health outcomes research consultants/research scientists
- Regulatory directors, scientists, and associates
- Product directors, managers, and associates of the brand teams
- Legal counsel
- Therapeutic area physicians, development CRP/Ss, medical affairs CRP/Ss, early phase physicians, and Sr. Medical leaders
- Global Marketing director or manager
- Corporate patient safety
External Contacts
- Scientific and clinical experts, thought leaders
- Lilly clinical investigators
- Practicing physicians/prescribers
- Regulatory agency personnel
- Professional association staff and leaders
- Disease advocates and lay organizations focused on relevant health issues
- Formulary representatives (private and government)
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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$198,000 - $356,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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