Director, Medical - Clinical Research Scientist

Lilly • Indianapolis, IN

2d • $177,000 - $338,800

About The Position

The Cardiometabolic Research (CMR) Program Clinical Research Scientist contributes to the development, conduct, and reporting of global clinical trials for compounds in the therapeutic area, including an evolving portfolio targeting women’s health. The role supports implementation of trials, adverse-event reporting, review of protocols and study reports, publications and data dissemination, product labeling, grant submissions and contracts, regulatory interactions, licensing assessments, and outreach to the external clinical community. The scientist also works with research scientists to identify lead compounds and clinical candidates and to plan preclinical studies. Core tasks are delegated according to experience level.

The position focuses primarily on early-phase compounds and may include clinical planning; design and oversight of Phase Ib and Phase IIa/IIb studies; protocol development; collaboration across clinical, quantitative, discovery, and nonclinical teams; patient-safety monitoring; scientific data dissemination; regulatory support; business and customer support; and continued development of scientific and technical expertise. The role also includes internal training, peer review, scientific consultation, collaboration with late-stage development colleagues on patient needs, and leadership of matrixed cross-functional teams.

The role requires a relevant PhD and at least five years of clinical development experience. Clinical research or pharmaceutical medicine experience and knowledge of the drug-development process are preferred. Domestic and international travel may be required as appropriate to support the team.

Requirements

• PhD in a relevant field, such as endocrinology, reproduction, internal medicine, developmental biology, immunology, cell biology, physiology, pharmacology, or neuroscience.
• At least 5 years of clinical development experience.
• Fluency in English, including written and verbal communication.
• Interpersonal, organizational, and negotiation skills.
• Ability to influence others across and within functions to foster a positive working environment.
• Excellent teamwork skills.
• Willingness to travel domestically and internationally as appropriate to support the team.

Nice To Haves

• Clinical research or pharmaceutical medicine experience.
• Knowledge of the drug-development process.

Responsibilities

• Contribute to overall development strategies and clinical plans, focusing on studies required for product decisions, and support preparation of high-level Phase III plans.
• Collaborate with clinical research staff, consultants, investigators, and quantitative scientists to design, conduct, and report global Phase Ib and Phase IIa/IIb clinical trials.
• Work with discovery scientists on research strategies, clinical candidate selection, and preclinical development.
• Collaborate with nonclinical pharmacologists to translate animal-study observations into human studies and biomarker development.
• Collaborate with drug-disposition scientists on human pharmacokinetic and drug-metabolism studies; support PK/PD modeling and dosing and patient-population selection.
• Design and oversee Phase Ib and Phase IIa/IIb clinical studies, clinical trial protocols, and development and biomarker qualification studies.
• Collaborate on protocols and data-collection requirements; participate in investigator identification and selection.
• Plan, initiate, and conduct worldwide Phase I and II trials with consultants and investigators.
• Review risk profiles and local informed-consent documents to ensure appropriate communication of risks to study subjects.
• Ensure administrative requirements for study initiation and conduct are documented in accordance with Good Clinical Practices, applicable laws, and local requirements.
• Participate in study start-up and provide training and information to investigators and site personnel.
• Serve as a resource to clinical research monitors, investigators, and ethics review boards during study conduct.
• Address investigators’ and study personnel’s scientific information needs.
• Monitor patient safety and track and follow up on adverse events in accordance with corporate policies and procedures.
• Comply with laws, regulations, and global policies concerning data dissemination and interactions with external health care professionals and customers.
• Address unsolicited scientific-information needs from external health care professionals in accordance with applicable guidelines.
• Participate in clinical-trial data reporting and registry activities; consider, review, or develop health-economic and pharmacoepidemiologic aspects of research.
• Support symposia, advisory boards, and other health care professional meetings.
• Participate in data analysis, scientific-data dissemination, and preparation of final reports, slide sets, abstracts, posters, and manuscripts.
• Prepare or review scientific information responding to customer questions or media requests in accordance with compliance policies.
• Provide congress support, including answering questions, presentations, medical-booth staffing, and engagement with thought leaders and customers.
• Support regulatory reports, including medical sections of INDs and Investigator Brochures, FDA advisory committee hearings, label discussions, and responses to regulatory issues.
• Develop and review labeling modifications with regulatory and safety groups; participate in risk-management planning and provide medical expertise to regulatory scientists.
• Understand the scientific and medical needs of CMR Program Phase customers, including payers, patients, and health care providers.
• Advise global business units on potential markets for development compounds and in-licensed projects or compounds; support business development with regulatory and corporate affairs groups.
• Establish and maintain relationships with external experts, thought leaders, the medical community, trade associations, and professional societies.
• Participate in patent development and lead definition of the Patient Journey and corresponding Moments of Truth, serving as a patient advocate and medical expert.
• Evaluate relevant medical literature and maintain knowledge of medical, scientific, clinical-practice, access, preclinical, clinical-pharmacology, and clinical developments relevant to the therapeutic area and molecules.
• Consult with health outcomes staff, marketing professionals, and management regarding potential medical needs addressed by drug candidates.
• Pursue relevant extramural scientific experiences and attend scientific symposia; maintain awareness of current clinical practices through experience and contacts.
• Set and meet professional-development goals and coach and provide feedback to coworkers.
• Participate in recruitment, diversity, and retention efforts, as well as committees, initiatives, and task forces as requested.
• Model leadership behaviors, lead matrixed cross-functional teams, and represent patients and the Lilly brand.

Benefits

• Company bonus eligibility for full-time equivalent employees, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including 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, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree