Development Clinical Research Physician, Immunology

at  Lilly

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 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.

ORGANIZATION OVERVIEW:

At Lilly, we unite caring with discovery to make life better for people around the world. Our more than 40,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of diseases, and give back to our communities. We give our best effort to our work, and we always put people first. We’re looking for people who are determined to make life better for patients around the world.
Eli Lilly Cork, has a talented diverse team of over 1,800 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Patient Safety, Clinical Development, Clinical Trials and more. Lilly offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Come join our team - Be creative, be an innovator, and most of all, be yourself!

BASIC REQUIREMENTS:

Medical Doctor or Doctor of Osteopathy.

• Physicians must have completed education and training at a medical school that meets the requirements of the US Liaison Committee on Medical Education (LCME).
• US-trained physicians (Medical Doctor or Doctor of Osteopathy) must have achieved board eligibility or certification in Immunology.
• Non-US trained physicians must have specialist training in Immunology or associated areas which include but are not limited to Gastroenterology, Dermatology or Rheumatology.
• Previous people management experience
• Strong administrative and leadership skills
• Demonstrated knowledge of the drug development process
• 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.

ADDITIONAL SKILLS/PREFERENCES:

• Clinical research or pharmaceutical medicine experience preferred
• 5 years of work experience in Immunology
• Minimum of 5 years of professional experience in pharmaceutical drug development with demonstrated experience and knowledge of clinical research and the drug development process.
• Fluent in English, written and verbal communications
• Ability to engage in occasional domestic and international travel to the degree appropriate to support the business of the team.

Through the application of scientific and medical training, and relevant clinical expertise the Development Clinical Research Physician (CRP) participates in: the development, implementation, conduct and reporting of global clinical trials in support of registration and commercialization of the product; 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, 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 Clinical Research Physician must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws and guidance’s, Good Clinical Practices (GCP), 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. The primary responsibilities of the Development CRP are generally related to late-phase and marketed compounds.
Specific responsibilities may include but are not limited to:

Clinical Planning

• Contribute to the 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

• Plan, collaborate on and review scientific content of clinical documents such as clinical trial protocols, clinical study reports, and submissions (for example, annual reports) according to the agreed-upon project timeline.
• Provide oversight and input into informed consent documents.
• 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 appropriate communication of risk to study participants.
• Participate in investigator identification and selection, in conjunction with clinical teams.
• Ensure that the 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 GCP and local laws and requirements.
• Assist in the 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 a 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 the 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.
• Review publications, as requested.

Scientific Data Dissemination/Exchange

• Knowledge of and compliance with local laws, regulations, global policies and procedures with respect to data dissemination and interactions with external healthcare professionals.
• Understand and actively address the unsolicited scientific information needs of external healthcare professionals according to the 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 healthcare professionals.
• Support medical information associates in the 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 healthcare professionals as per global standard operating procedures.
• 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.
• Develop and maintain appropriate collaborations and relationships with relevant professional societies.
• Support the design of customer research as a medical expert.
• Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons, and global patient outcomes personnel.
• Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.

Regulatory Support Activities

• Participate in the 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, preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory responses, from a global perspective.
• Participate in advisory committees.
• Participate in risk management planning along with affiliates and Global Patient Safety.

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.
• Responsible for the scientific training of the clinical study team.
• Act as scientific consultant and protocol expert for clinical study team members and others.

General Responsibilities

• Support the management team, in the preparation and administration of the 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.
• Participate in active coaching by providing timely and constructive feedback to co-workers, and others on the medical team, in the spirit of development, increased team effectiveness, and cohesiveness.
• Participate in committees, process improvement initiatives, and task forces as requested by local/corporate management.
• Ensure 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 leadership behaviors.
• Be an ambassador of both patients and the Lilly Brand.