The Executive Director will report to the Senior Vice President of Cardio-Renal Research and Early Clinical Development and should have broad scientific expertise in cardiovascular diseases. Additional experience in renal diseases is a bonus. He/She should have a demonstrated track record of developing clinical development strategies and trials in various diseases including, but not limited to, heart failure, ASCVD, hypertension, pulmonary hypertension, and/or CKD. The Executive Director; leveraging her/his scientific training, clinical expertise, and relevant experience; will work with preclinical teams to develop sound preclinical strategies to progress molecules to first-in-human trials and develop sound clinical development strategies and trials across all phases of development consistent with best clinical practices. She/He will conduct and support clinical trials in each phase of development. She/He will support commercial decision for compounds in various disease states in other therapeutic indications as determined by Cardio-Renal and DOCTA management. The Executive Director will also supervise 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, regulatory submissions and data dissemination. The Executive Director will take a leadership role in interactions with regulatory bodies worldwide and other governmental agencies as needed to advance the clinical development. He/She will also engage external medical and scientific experts as needed to represent Lilly and to engage them in the development of molecules and implementation of clinical trials.
The Executive Director must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. 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.
Core Job ResponsibilitiesThe core job responsibilities include those listed below as well as all other duties as assigned.
Clinical Planning- Collaborate with the Preclinical groups, Clinical Pharmacology, Health Outcomes and New Product Planning in the development and maintenance of Draft Launch Labels and Value Propositions that address key customer needs (patient, provider, and payer); are consistent with known biological characteristics and effects of the molecule; consider all appropriate clinical strategies, development plans and study protocol designs.
- Contribute to global alignment of clinical strategy and clinical plans with business unit and LRL priorities.
- Understand and keep updated with the pre-clinical and clinical data relevant to molecules
- Represent Lilly in external forums where standards, common protocols, assessment instruments, regulatory standards and clinical guidelines concerning drug development
Clinical Research/Trial Execution and Support- Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (e.g., sample size, patient commitment, timelines, grants, and governance review interactions).
- Review and approve risk profiles 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 (i.e., 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.
- Knowledge of clinical research methodology including latest developments in relevant areas of biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations and regulatory standards.
- 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.
- Prepare or review scientific information in response to investigator questions or media request.
- Support data analysis and the development of slide sets and publications (abstracts, posters, manuscripts).
- Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national and international basis.
- Develop and maintain appropriate collaborations and relationships with relevant professional societies.
- Support the design of customer research as medical expert in collaboration with New Product Planning.
- Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons and health outcomes personnel.
- Provide technical support for due diligence activities as needed.
- 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 regulatory documents globally in collaboration with affiliates, regulatory, and legal.
- Provide medical expertise to regulatory scientists.
- Support / assist in the preparation of regulatory reports, including INDs, FDA annual reports, regulatory responses and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA communication and resolution of regulatory issues, including regulatory response, from a global perspective.
- Participate in face to face meetings with FDA, EMEA and other regulatory bodies as needed.
- 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, New Product Planning, and business development.
- Understand the scientific information needs of all Development customers (business unit, 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 health outcomes research efforts.
- Establish effective collaborations with New Product Planning and Health Outcomes personnel 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 (pricing, reimbursement, and access) organization, in particular giving clinical input and insight to develop and defend compound valuations.
- Review, offer scientific and creative support for, New Product Planning, technical probability assessments and valuation activities as needed.
- Become familiar with market archetypes and potential influence on the medical interventions for the product.
- Participate in payer, commercialization and regulatory advisory boards.
Scientific / Technical Expertise and continued development
- Critically read and evaluate the relevant medical literature; know the status and data from competitive molecules in development; and keep updated with medical and other scientific developments relevant to the supported molecules
- Maintain and disseminate within Lilly information on latest developments in the pathophysiology, diagnosis, etiology, treatment and management of disease states of the supported molecules
- Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the priority areas
- Explore and take advantage of opportunities for extramural scientific experiences.
General Responsibilities
- Support the management team in preparation and administration of the development budget.
- Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers
- 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 effective leadership behaviors.
- Be an ambassador for the Lilly Brand.
Basic Qualifications:- 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
- Five years of experience in clinical research/drug development in academia or industry including the design and implementation of large global clinical trials
Additional Skills/Preferences:- Board certification in cardiovascular diseases.
- Candidates with board certification in renal diseases will also be considered.
- Clinical trialist with a track record of developing clinical plans and execution of studies in the pharmaceutical industry
- Demonstrated evidence for the capacity to lead and manage groups of professionals
- Demonstrated administrative skills, including strong team work skills
- Demonstrated evidence of the ability to work within Lilly's governance structure
- Strong communication, interpersonal, and negotiation skills
- Additional PhD training is a plus
- Ideal would be additional qualification for business accumen
- Ideal Five years of experience in clinical practice with at least 2 years in cardiovascular or renal diseases.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$243,000 - $356,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). I
