Senior/Executive Director - Dermatology Portfolio Medical Affairs

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.

As a Clinical Research Physician specializing in Dermatology within Medical Affairs, you will provide critical medical expertise and leadership for Lilly's dermatology portfolio. This role focuses on scientific and medical strategy, evidence generation, and communication of clinical data to support patient access and appropriate use of our innovative dermatological treatments.

The CRP works closely with the global Development teams, Therapeutic Area Program Phase, Early Phase/Clinical Pharmacology, and Translational Medicine teams in new product development activities over the entire spectrum of drug development and clinical trial phases.

Specific activities include:

• Developing or contributing to the global and/or regional clinical/medical plan.
• Development, conduct and reporting of local clinical trials.
• Implementation of global clinical trials conducted in local affiliates/countries.
• Reporting of adverse events as mandated by corporate patient safety.
• Review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts.
• Contacts with regulatory and other governmental agencies
• Outreach aimed at the external clinical customer community, including thought leaders.
• Various medical activities in support of demand realization

Primary Responsibilities:

The primary responsibility of the Medical Affairs CRP is to provide expert medical leadership and support to all aspects of the local business, to ultimately enhance the customers' experience and develop medical strategies that improve patient outcomes. This includes informing the identification of Clinical Care Gaps (CCG), Integrated Evidence Generation (IEG) planning, product lifecycle planning, and evidence dissemination plans aligned with medical strategy.

The CRP provides local marketed product support (informing the development of the "patient journey" and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for New and Supplemental New Drug Submissions and participating and presenting at meetings with government regulatory agencies), medical support for pricing, reimbursement and access (PRA), providing  medical guidance on the PRA plan and interacting with government PRA agencies as needed), and  leading in  local scientific data dissemination (leading  and presenting at conferences, advisory boards, etc., and overseeing the development of the scientific content of educational programs).

These responsibilities are generally related to late phase and marketed compounds but can also include early phase trials (for example, phase I and II trials). The CRP is responsible for collaborating with the global teams in the planning, startup and conduct of phase 3b/4 studies (and phase I and II studies where applicable), as well as non-clinical trial solutions/activities that are conducted in affiliates/countries as described in the clinical plan. 

Minimum Qualification 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. US trained physicians must have achieved board eligibility or certification. Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.

• 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). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm

Additional Preferences:

• Minimum of 3+ years of clinical experience post-residency, with a strong focus on dermatology.
• Prior experience in the pharmaceutical industry, specifically in Medical Affairs or Clinical Development, is highly desirable.
• Experience with clinical trial design, execution, and interpretation of results.

• In-depth understanding of dermatological diseases, current treatment paradigms, and unmet needs.
• Strong knowledge of pharmaceutical industry regulations and compliance requirements (e.g., PhRMA, FDA).

• Familiarity with medical affairs activities, including KOL engagement, medical education, and publication planning.
• Excellent written and verbal communication skills, with the ability to convey complex scientific information clearly and concisely to diverse audiences
• Strong analytical and critical thinking skills.
• Demonstrated ability to build and maintain strong professional relationships.
• Strategic thinking and problem-solving abilities.
• Proficiency in interpreting and presenting scientific data.

• Knowledge of drug development process relevant to the United States
• Demonstrated ability to balance scientific priorities with business priorities
• Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills
• Demonstrated ability to influence others (both cross-functionally and within the function) 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.
• Prefer Indianapolis/US based remote

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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