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