Senior Medical Advisor, Clinical Development - Lilly BioMedicines
Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Development Clinical Research Physician (CRP) participates in: the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; 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; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization. The CRP serves as a scientific resource for study teams, departments, and others as needed.
- Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design.
- Contribute to business unit and global alignment of clinical strategy and clinical plans.
- Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
Clinical Research/Trial Execution and Support
- Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (for example, annual reports) according to the agreed upon project timeline.
- Provides oversight and input into ICDs
- 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).
- Review and approve risk profiles to ensure to ensure appropriate communication of risk to study subjects.
- Participate in investigator identification and selection, in conjunction with clinical teams.
- Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
- Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
- Serve as resource to clinical operations personnel / clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
- Understand and actively address the scientific information needs of all investigators and personnel.
- 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.
- Participate in reporting of clinical trial data in Clinical Trial Registry activities.
- Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
- Support medical information associates in preparation and review of medical letters and other medical information materials.
- Prepare or review scientific information in response to customer questions or media requests
- Provide telephone follow-up or specific written information requested by health care professionals as per global SOPs.
Regulatory Support Activities:
- Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal.
- Provide medical expertise to regulatory scientists.
- Support / assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
- Participate in advisory committees.
- Participate in risk management planning along with affiliates and Global Patient Safety (GPS
Business/ customer support (pre and post launch support)
- Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans personnel and other cross-functional management during the development of the local business plan.
- Understand and anticipate the scientific information needs of all Development customers (payers, patients, health care providers).
- Actively address Development customer (payer, patient, and health care providers) questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research efforts.
- Establish effective collaborations with marketing personnel in the various geographic regions to further corporate demand realization.
- Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts.
- 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.
- Support business-to-business and business-to-government activities as medical expert.
- Contribute actively on an ongoing basis to the strategic planning for the brand.
- By offering scientific and creative input, contribute to the development, review, and approval of promotional materials and tactics as needed.
Scientific / Technical Expertise and continued development
- 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.
- 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).
- 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
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.
- 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. 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).
- At least 3 years of pharmaceutical industry experience and/or strong back ground in biologic medications
Primary internal interactions
- Director(s)-Clinical Operations, managers or project managers
- Clinical planning, operations, CRPs/Ss, other research staff
- Scientific communication associates
- Medical information associates
- Medical liaisons
- Global patient outcomes research consultants/research scientists and global patient outcome liaisons
- Regulatory directors, scientists, and associates
- Product directors, managers, and associates of the brand teams
- Sales district managers and sales representatives
- Legal counsel
- Therapeutic area physicians, development CRP/Ss, medical affairs CRP/Ss, early phase physicians, and Sr. Director-Medicals
- Global Marketing director or manager
- Corporate patient safety physician
- Scientific and clinical experts, thought leaders
- Lilly clinical investigators
- Practicing physicians/prescribers
- Regulatory agency personnel
- Professional association staff and leaders
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.
- Prefer that qualified candidates are legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Experience of BLA or sBLA regulatory submission of an immunology medicine preferred
- Experienced of medical monitoring, data analysis and data reporting for pivotal and/or proof of concept immunology clinical studies (preferably for dermatology or rheumatology or gastroenteology) preferred for candidates from the pharmaceutical industry or experience as a principle investigator for a late phase development clinical studies if a non pharma experienced candidate.
- Demonstrated knowledge of biologic drug development process
- Fluent in English; both written and verbal communications
- Excellent public speaking skills
- Demonstrated strong communication, interpersonal, organizational, teamwork 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.
- Expertise in the clinical development of endocrine therapies for patients with breast cancer
- Support the management team, including the Director-Medical, in preparation and administration of the business unit development budget.
- Actively set and meet individual professional development goals and contribute to the development of others.
- Actively participate in recruitment, diversity, and retention efforts.
- Collaborate proactively and productively with all alliance, business and vendor partners.
- Participates in active coaching by providing timely and constructive feedback to co-worker, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness.
- Participate in committees, Six Sigma initiatives and task forces as requested by local/corporate management.
- Ensures that at all times is adequately qualified and trained in the tasks required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self.
- Model the leadership behaviors.
- Be an ambassador of both patients and the Lilly Brand.