Clinical Research Scientist – Medical Affairs

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Clinical Research Scientist – Medical Affairs

Purpose:

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 Director-Medical and Business Unit Team Physician/Regional Medical 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 CRS is aware of and ensures that all activities of the medical team (and direct reports, if applicable) are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research and activities are aligned with the medical vision.

Primary Responsibilities:  This job description is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.  Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

The primary responsibility of the Business Unit- Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of the local business, to ultimately enhance the customers' experience in interacting with the company. This includes local marketed product support (participate in 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 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 CRS 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. In addition, the CRS, if assigned by the Director-Medical and/or Business Unit Team Physician/Regional Medical Leader, is responsible for support of global Development studies conducted in affiliates/countries. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.

• 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 global 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.
  • Contribute as a scientific and clinical 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 currently marketed brands.
  • By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team.
  • Support training of sales representatives, and other medical representatives.
  • 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 patient advocate, as well as a medical expert.
  • Provide medical insight and training to patient support programs (for example, Diabetes Nurse Educators Service).
  • Understand and apply knowledge of customer insights to all customer-related activities.
  • Participate in local or national trade associations as appropriate.
• 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.
  • Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above.
  • Support the planning of symposia, advisory board meetings, and and/or the facilitation of other meetings with health care professionals.
  • Support medical information associates in preparation and review of medical letters and other medical information materials.
  • Support training of local medical personnel, including medical and/or outcome liaisons and health outcomes staff.
  • Prepare or review scientific information in response to customer questions or media requests.
  • Provide follow-up to 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 scientific 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.
  • 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.
  • Participate in reporting of clinical trial data in Clinical Trial Registry activities.
• Clinical Planning
  • Communicate and collaborate with Director-Medical and Business Unit Team Physician/Regional Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs as delegated by Director-Medical and Business Unit Team Physician/Regional Medical Leader, as needed, to global Medical Affairs and Development teams, Global Patient Outcomes/Real World Evidence, PRA, Therapeutic Area Program Phase, and Early Phase /EPM/Translational Medicine teams.
  • Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams, Global Patient Outcomes/Real World Evidence, and PRA teams to ensure Phase 3, 3b, and 4 (and Phase I and II where applicable) clinical programs meet the needs of local/regional customers (for example, through global medical planning processes).
  • Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
  • Represent the clinical needs of the country/region to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design.
• Clinical Research/Trial Execution and Support
  • Review and approve local informed consent documents and risk profiles to ensure appropriate communication of risk to study subjects.
  • 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).
  • Collaborate with Clinical Research staff, regional clinical operations staff, statisticians, global patient outcomes, Research Scientists and selected investigators in the development of protocols and data collection requirements.
  • Participate in investigator identification and selection, in conjunction with clinical teams.
  • Ensure that the clinical operations team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
  • Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel.
  • Serve as resource to Clinical Research site monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
  • Review lIT proposals and publications, as requested
  • Contribute to global alignment of Phase 3b/4 clinical studies (and Phase I and II studies where applicable) planned by country(ies) or global Development and Medical Affairs teams.
  • 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.
• Regulatory Support Activities
  • Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of local label. Provide medical expertise to regulatory scientists.
  • Support I assist in the preparation of regulatory reports, preparation for regulatory agency advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from an affiliate/country perspective.
  • Participate in advisory committees.
  • Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS).
• Scientific / Technical Expertise and continued development
  • Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer-term (3-5 years).
  • 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.
  • Responsible for the scientific training of the clinical study team.
  • Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
  • Explore and take advantage of opportunities for extramural scientific experiences.
  • Attend, contribute and participate in medical congresses/scientific symposia.
• General Responsibilities
  • Support the business unit management team, including medical leadership in preparation and administration of the local or business unit medical budget.
  • Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers, and direct reports as applicable.
  • Collaborate proactively and productively with all alliance, business, and vendor partners.
  • Participates in active coaching by providing timely and constructive feedback to co-workers, others on the clinical medical team, in the spirit of development, increased team effectiveness and cohesiveness.
  • As applicable, works closely with direct reports on performance management plans (objectives), development plans, and documentation of their expertise. Keeps these documents and plans up to date. Meets regularly with each direct report to coach, mentor, evaluate performance, evaluate training and development needs, and monitor career development goals. Maximizes each individual direct report's career potential, maximizing the value to the organization.
  • Actively participate in recruitment, diversity, and retention and hiring efforts as applicable.
  • Participate in committees, Six Sigma initiatives and task forces as requested by business unit/corporate management.
  • Model the leadership behaviors.
  • Be an ambassador of both patients and the Lilly Brand.

Launch Readiness Planning

• The medical launch leader is responsible for the strategy, planning and execution of those medical activities that will complement registration studies in achieving successful product launches and increasing benefits to patients. The focus of the launch leader and her/his supporting team are on the needs and education of payers, prescribers, and the other stakeholders who influence patients’ treatment access or benefit.
• Collaborate with global brand development teams, Business Unit Team Physician/Regional Medical leader, and local cross-functional team members for launch preparations. This will include medical strategy guidance for the following brand development activities:
  • Insights, patient segmentation, competitive landscape, patient journey, etc.
  • Local position, brand planning, scientific story, etc.
  • Local commercialization activities (Brand planning, Promotional Messages, etc)
  • Responsible for launch readiness capability, partner with cross-functional teams to develop launch readiness plan including recommended capacity, tactics and OPEX to support successful launch.
  • Responsible to lead and drive competition of the Medical Affairs launch readiness activities required for a successful launch of a medicine.

Minimum Qualification Requirements:

• 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

3-5 years of clinical experience or 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

Clinical trial experience Experience in areas relevant to drug discovery 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 content = 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
• 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

Other Information/Additional Preferences:

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, and Regional Medical Leader, 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)

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ***************@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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