Senior Medical Advisor

Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Business Unit - Medical Affairs Clinical Research Physician (CRP) 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 CRP may also work closely with 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. The CRP serves as a scientific resource for study teams, departments, and others as needed. The CRP is aware of and ensures that all activities of the medical team 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.

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 medical 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.

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 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.
• 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.
• 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, global Medical Affairs and Development teams, Global Patient Outcomes/Real World Experience, 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 Experience, 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 Scientists (CRSs), regional clinical operations staff, statisticians, health outcomes, research scientists and selected investigators in the development of protocols and data collection 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.

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 / 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.
• Critically read and evaluate the relevant medical literature
• 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.
• Attend, contribute and participate in medical congresses/scientific symposia

Company Overview

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.

Basic Qualifications

• Medical Doctor - 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.
• Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME).
• Seven to ten years of Clinical research or pharmaceutical medicine experience

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 global patient 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 Leaders, 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)

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

Additional Skills/Preferences

• Knowledge of drug development process relevant to country/region preferred
• 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) 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.