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Job Details

Medical Director Clinical Development Lilly BioMedicines

Company name
Eli Lilly and Company

Location
Indianapolis, IN

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Profile

Company Overview\> Company Overview 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 39,000 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\u2019re looking for people who are determined to make life better for people around the world. Responsibilities The Director-Medical is delegated various responsibilities by the Sr. Director-Medical or equivalent role to provide leadership, supervision, coordination, coaching, career development, and performance management for the staff within a specified therapeutic or product subgroup of Development in the Business Unit. The position is a developmental role for future administrative leaders and is intended to provide a balance of administrative and technical responsibilities. The position requires a partial transition from direct CRP contributor to managerial\/supervisory responsibilities and activities of achieving results through others, and supporting the management team in fulfilling corporate goals and initiatives. The Director-Medical will provide strong leadership, ability to influence, both within and outside the team. The Director-Medical supports the clinical staff within his\/her product or therapeutic group to ensure high quality, timely submissions, and successful commercialization. The Director-Medical may be delegated such responsibilities as approval authority for grants and contracts, protocols and protocol amendments, label changes, scientific e-disclosure, informed consent documents, travel authorizations, expense reports, and other documents related to the work of the group. In addition to his\/her focused administrative responsibilities, the Director-Medical participates in strategic planning for and oversight of the clinical research and medical support activities of the Director's area of responsibility. The Director-Medical will also interact with external consultants, opinion leaders, and worldwide regulatory agencies, and will provide oversight for responding to medical and regulatory questions and requests related to products. The Director-Medical helps to ensure that the team's activities are clearly aligned with Global Patient Safety (GPS), and as appropriate, with Program Phase Medical and Clinical Pharmacology. The Director-Medical plays a significant role in submission, registration, and product launch. In this role, the Director-Medical maintains close contact with relevant local and global clinical research management, marketing management, and corporate teams. In the absence of the Sr. Director-Medical, the Director-Medical may carry out certain responsibilities of the Director. The Director-Medical maintains the ongoing responsibilities of a Clinical Research Physician for product support and clinical research in his\/her area (see area job description for CRP for review of core job responsibilities), adjusted and balanced to the level and extent as appropriate to correspond to the needs of the area and role. The Director-Medical is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidances (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 and are aligned with the medical vision. Core Job Responsibilities The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned. Career Development and Performance Management of direct reports Works closely with direct reports, to develop their performance management plans (objectives), development plans, corporate resumes, performance appraisals. Keeps all performance and career related documents and plans for direct reports up to date. Meets regularly with each direct report to coach, mentor, evaluate progress toward objective fulfillment, evaluate training and development needs, and monitor career development goals. Maximizes each individual direct report's career potential, maximizing the value to the corporation. Responsible for retaining talented people for the long term. Responsible for presenting the activities, desires, capabilities, and achievements of direct reports to the Sr. Director-Medical, Medical management group, HR, and Global Medical Capabilities and Development department for talent assessment, performance evaluation, and timely promotion consideration. Accountable for CRP\/S capacity planning and work allocation. Recognizes and appropriately rewards exceptional performance, talent, and\/or contribution. Lead and appropriately delegate to the physicians and clinical research scientists on the team who are responsible for clinical development plans. Ensures that all direct reports are adequately qualified and trained in the tasks they are required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self and direct reports. Oversight of clinical planning, budgeting and execution Respect the value and contributions of paramedical technical talent on the team. Partner with cross-functional team members to assist the Sr. Director-Medical in the development of the clinical strategy and clinical plans. Partner with the medical leadership in effective budget planning and integration of clinical\/business plans. Ensures placement of the clinical welfare of patients and subjects using a Lilly product or participating in a Lilly clinical investigation above all other considerations. Ensures medical group meets or exceeds commitments for planned and agreed upon clinical research. Monitors progress toward implementation of the clinical research plans, and takes appropriate steps with the responsible clinical plans personnel and CRPs if progress is not adequate. Monitors progress toward implementation of the other deliverables from the medical team and take appropriate steps with the responsible cross-functional management team(s) if progress is not adequate. Works closely with the Sr. Director-Medical to monitor operational expenses of the group, and takes appropriate actions if there are substantial deviations from approved budgets. Scientific and Technical Expertise Maintains his\/her deep scientific, technical expertise and support, conducting activities in clinical research, submission, and commercialization support balanced with administrative activities as agreed upon by Sr. Director-Medical. Provide technical expertise, protocol development oversight, and input into development of informed consent documents. Understand and keep updated with the pre-clinical, clinical pharmacology, and clinical data relevant to the team molecule. 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 team. Role model and functional member of the appropriate research, submission, registration, and commercialization support teams. Visibly active in business unit\/her therapeutic area to maintain credibility with internal and external colleagues and the larger organization, as well as to enhance career satisfaction. Review and approve liT proposals and publications, as requested by Sr. Director-Medical 40271BR Basic Qualifications Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty\/subspecialty 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 http:\/\/www.in.gov\/pla\/2799.htm Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. Pharmaceutical industry work experience is required. Additional Skills\/Preferences Professional experience in clinical research\/drug development including the design and implementation of large global clinical trials is strongly preferred. 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 Demonstrated experience with strong communication, interpersonal, and negotiation skills Ability to travel away from office, both domestic and international to the degree appropriate to support the business of the team. Fluent in English, verbal and written communication Additional Information Lilly is an EEO\/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Company info

Eli Lilly and Company
Website : http://www.lilly.com

Company Profile
Lilly makes medicines that help people live longer, healthier, more active lives. We were founded by Eli Lilly in 1876, and are now the 10th largest pharmaceutical company in the world. We have steadfastly remained independent, but not isolated. Across the globe, Lilly has developed productive alliances and partnerships that advance our capacity to develop innovative medicines at lower costs. Lilly is consistently ranked as one of the best companies in the world to work for, and generations of Lilly employees have sustained a culture that values excellence, integrity and respect for people.

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