Purpose:
Lilly Regenerative Medicine is seeking a highly motivated and experienced Clinical Research Physician (CRP) to join our Gene therapy Medical Development function. This role will be instrumental in the clinical development of innovative gene therapies for sensory and rare disorders, contributing to study design, execution, and interpretation of clinical trial data.

Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the 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.

The CRP must be aware of and ensure that all activities of the medical team 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.

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. Core Job Responsibilities: The primary responsibilities of the Development CRP are generally related to early-phase and also late-phase assets. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.

Clinical Planning
• Collaborate with Discovery; contribute to 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 clinical development plan
• 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.
• 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.

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.
• 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 experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis.
• Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons and global patient outcomes personnel.
• 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 analysis, development of scientific data dissemination, and preparation of final reports and publications.

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 BLAs, FDA annual reports, 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 commercialization activities by working closely with 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).
• 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.
• Take a leadership role in defining the Patient Journey based on his/her medical knowledge. Become a patient advocate, as well as a medical expert.

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.
• Explore and take advantage of opportunities for extramural scientific experiences.
• Attend scientific symposia.

General Responsibilities
• Actively set and meet individual professional development goals and contribute to the development of others.
• Support the management team, as needed, in preparation and administration of the development budget.
• Actively participate in recruitment, diversity and retention efforts.
• Collaborate proactively and productively with all alliance, business and vendor partners.
• Participate in active coaching by providing timely and constructive feedback to co-workers, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness.
• 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

Minimum Qualification Requirements:

• Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in relevant field 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). For the recognized list of foreign medical schools and the disapproved list, see PLA: Medical Licensing Information and Medical Education | MBC

Additional Preferences:
• Experience in gene therapy and/or rare disease Medical Affairs or Patient Advocacy.
• Minimum of 3-5 years of experience in clinical research within the pharmaceutical industry or academic research setting; demonstrates understanding of drug development processes, Good Clinical Practice (GCP), and regulatory requirements. Experience with global clinical trials is a plus.
• Strong scientific acumen and ability to critically evaluate clinical data.
• Learning agility to comprehend and effectively communicate large amounts of complex scientific content in a clear and concise fashion.
• Advanced presentation and computer skills with expertise in literature identification.
• Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
• Self-directed and able to effectively manage multiple priorities and projects.
• Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills
• Strong teamwork, including the ability to engage in professional relationship building and networking.
• Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment. Ability to work effectively in a multidisciplinary team 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; effective verbal and written communication skills.