Associate Vice President

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.

Lilly has innovated in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people impacted by diabetes. Lilly is seen as a global leader for insulin and incretins and has a broad pipeline to ensure continuous innovations for patients with Diabetes Mellitus and Obesity and it is also widening its scope to complications related to metabolic disease, including CHF, MASH, CKD and ASCVD.

The AVP should have broad expertise in Endocrinology and/or obesity. Lilly is seeking individuals with expertise in obesity/weight regulation and associated conditions such as MASH and CKD. The ideal candidate will have established expertise in drug development, including minimum 5 years experience in the industry. He/She should have demonstrated learning agility and the willingness to dive into new disease areas. Leveraging his/her scientific training, clinical expertise, and relevant experience, the AVP will develop clinical plans in the spirit of Next Generation Research, enabling crisp decision making. He/She will conduct and support clinical trials in all phases of development. He/She supports commercial decision for compounds in various disease states with the initial focus obesity and associated complications but branching out in other therapeutic indications as determined by Diabetes, Obesity and Complications Research management. The AVP 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 AVP 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 AVP 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 Responsibilities

The core job responsibilities include those listed below as well as all other duties as assigned.

Clinical Planning
•  Collaborate with the Diabetes, Obesity and Complications 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); drive development decisions that 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 under management
•  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 organization, in particular giving clinical input and insight to develop and defend compound valuations.
•  Review and 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 . click apply for full job details