Medical Affairs Manager, Oncology
The CRS is an integral member of an Global Product Team for strategic planning in the support of launch and commercialization activities. The CRS may also work closely with global Development, Therapeutic Area Program Phase, Early Phase / Exploratory Program Medicine (EPM), and Translational Medicine team(s) in new product development activities over the entire spectrum of drug development and clinical trial phases. Through application of scientific training, clinical expertise and relevant experience, the Global Oncology Business Unit Medical Affairs clinical research scientist participates in: the 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, Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility. In addition, with input from the Product Medical Director and Medical affairs leadership 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 / Clinical Pharmacology, and Translational Medicine team(s).
The Clinical Research Scientist serves as a scientific resource for cross-functional teams, study teams, commercial, regulatory, legal 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, guidances (e.g. FDA, ICH, etc.), Good Clinical Practices (GCPs), company standards, CIA agreement, Lilly policies and procedures, and the strategic vision for Medical Affairs.
Core Job Responsibilities
The primary responsibility of the Business Unit- Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of the business, to ultimately enhance the customers' experience in interacting with the company. This includes launch planning global marketed product support . Specifically, the Medical Affairs CRS will support the Global Medical Affairs Lead in the development and execution of launch support programs including but not limited to: leading the scientific competitive landscape analysis, creating a scientific platform development and communications plans, scientific disaseas state educational strategy, developing and leading content and execution of internal medical training, and will 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 core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.
The core job responsibilities may include those listed below as well as other duties as assigned.
Business/ customer support (pre and post launch support)
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.
Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers)
Contribute as a scientific and clinical expert to activities and deliverables of the global medical affairs organization and articulate the scientific and clinical product value.
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 actively on an ongoing basis to the strategic planning for launch planning and 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 medical representatives and other team members as required.
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.
Understand and apply knowledge of customer insights to all customer-related activities.
Participate in local or national congresses and 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 the global medical education strategy, advisory board meetings, and and/or the facilitation of these and other meetings with health care professionals.
Support global 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,global thought leaders, and the medical community
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.
Regulatory Support Activities
Scientific / Technical Expertise and continued development
General ResponsibilitiesBasic 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:
- 3-5 years of pharmaceutical experience (>2 of which is in oncology medical affairs or oncology medical communications)
- Excellent scienitific communication, medical writing, interpersonal, teamwork, organizational and negotiation skills
- Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership 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
- Preference for Bridgewater, NJ location
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.
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
Scientific communication associates
Medical information associates
Global patient outcomes research consultants/research scientists and health outcomes liaisons
Regulatory directors, scientists, and associates
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)
Scientific and clinical experts, thought leaders
Lilly clinical investigators
Regulatory agency personnel
Professional association staff and leaders
Disease advocates and lay organizations focused on relevant health issues
Formulary representatives (private and government)