Clinical Research Scientist, Migraine and Headache Disorders
Indianapolis, IN
About the Position
Through the application of scientific and clinical training and expertise, the Clinical Research Scientist (CRS) is an integral member of the medical affairs, development or a business unit brand team for strategic planning in the support of launch and commercialization activities to meet patients’ needs and ultimately enhance the customers’ experience in interacting with the company. The definition of “customer” here includes patients, providers (HCPs) and payers. The CRS may also work closely with global Development teams, Therapeutic Area Program Phase, Early Phase I 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 in his/her therapeutic area of responsibility, the development, conduct and reporting of local clinical trials; the implementation of global clinical trials conducted in local affiliates/countries; the 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; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization. In addition, with input from the Medical Launch Leader, the CRS is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective Medical Affairs business unit brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase I Clinical Pharmacology, and Translational Medicine team(s).
The Clinical Research Scientist serves as a scientific resource for study teams, departments, and others as needed. The Clinical Research Scientist must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidance’s (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.
Responsibilities
The primary responsibility of the CRS is to provide expert scientific and clinical support to the business to ultimately enhance the customers’ experience in interacting with the company. Ensuring that the needs and education of payers, prescribers, and other nonregulatory stakeholders who influence patients’ treatment access or benefits are met; collaborating within GBD and affiliate/regional brand teams for launch preparation and commercial-related activities, providing input for brand development activities; focusing on product launches in the US and other countries
- Business/customer support (pre and post launch support)
- Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers
- Actively address customer (payer, patient and health care providers) questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts
- Contribute to the development of medical strategies to support brand commercialization activities by working closely with the Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan
- Support consumer activities as medical expert
- Establish effective collaborations with marketing personnel in the various geographic regions to further corporate demand realizatio
- Contribute actively on an ongoing basis to the strategic planning for brand
- Become familiar with market archetypes and potential influence on the medical interventions for the product
- Understand and apply knowledge of customer insights to all customer-related activities
- Gather and communicate scientific intelligence and clinical insights; identify key scientific developments, new research, therapies and/or other developments in the therapeutic area.
- Thought Leader Engagement
- Support implementation of thought leader engagement strategies/plans; seek consultation/collaboration from respective marketing team, GBD Medical Director/Development team, Global PRA, Thought Leader Capability Office, and Regional/Affiliate Med Affairs team.
- Engage with external scientific experts/thought leaders who share our mission and interest in our work
- Interact with Advocacy and Professional Relations; maintain relationships with advocacy groups/professional societies.
- Lead and present at conferences, advisory boards, etc., and participate in development and review of the scientific content of advisory boards as applicable.
- Listen, engage and partner with key stakeholders across medical and marketing to support development of Migraine Thought Leader Engagement & Strategy.
- Support, in partnership with TLE advisor, Medical and Marketing, the Migraine Platform Ad boards for the Global team.
- Engage with thought leaders to remove barriers and enable positive customer experiences.
- Support the planning of symposia, advisory board meetings, and and/or the facilitation of other meetings with health care professionals in partnership with TLE advisor and Medical Education Advisor.
- Scientific Data Dissemination/Exchange/Clinical Insights
- 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 actively address the unsolicited scientific information needs of external health care professionals according to guidelines.
- Responsible for supporting the development of slide sets by collaborating with the slide coordinator, through review and/or approval of slide decks and publication slide decks (abstracts, posters, manuscripts).
- 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 analyses, development of scientific data dissemination, and preparation of final reports and publications.
- Clinical Planning
- Clinical Research/Trial Support
- Scientific / Technical Expertise and continued development
- General Responsibilities
Basic Qualifications
An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of following:
1. 3-5 years of clinical experience or
2. 3-5 years of pharmaceutical experience (2 of which is in clinical development)
OR
Have a BS or Masters degree in health/medical/scientific or related field and 7-10 years of pharmaceutical experience that is directly related to at least one of the following
1. Clinical trial experience
2. Experience in areas relevant to drug discovery
3. Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory
affairs, medical affairs)
If experience is either in 2 and or 3 only (for example, no clinical trial experience), the following must be provided as supporting evidence of candidates ability/capability to perform in a CRS role
- Clear evidence and documentation of candidate’s direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical c medical, scientific or clinical information)
- Candidate’s selection for CRS role must be endorsed by the BU Med affairs/development VP or equivalent area Senior leadership
Additional Information
Primary internal interactions include, but not limited to:
- Therapeutic area directors, managers, or project managers
- Product directors, managers, and associates of the brand
- Clinical research staff
- Statisticians
- Scientific communication associates
- Medical information associates
- Medical liaisons
- Global patient outcomes research consultants/research scientists and health outcomes liaisons
- Regulatory directors, scientists, and associates
- Sales representatives
- Legal counsel
- Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, Directors-Medical.
- Corporate or regional patient safety physician(s)
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)
Additional Skills/Preferences
- 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
Interested in applying to this career opportunity?
Please email Taylor Frank, [email protected], and include Lilly Clinical Research Scientist – Migraine and Headache Disorders in the subject line.
About Eli Lilly and Company
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 39,000 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.
Lilly is an EEO/Affirmative Action Employer and 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.
