Director/Sr. Director, Clinical Development Design Hub – Neurology in Indianapolis

Job Description

Join American pharmaceutical leader Eli Lilly and Company, currently hiring Director/Sr. Director, Clinical Development Design Hub – Neurology in Indianapolis, Apply Lilly careers in Indianapolis Indiana.

 

Position : Director/Sr. Director, Clinical Development Design Hub – Neurology

Location : Indianapolis, Indiana

Job id: R-32890

 

Job Details

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 35,000 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’re looking for people who are determined to make life better for people around the world.Company OverviewAt Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.About the Design HubThe Design Hub (DH) is a centralized, cross-functional hub of Medical, Statistics, and Project Management experts working to enable high-quality, optimized clinical trial and program designs for all of Lilly’s assets.  It applies a thoughtful and innovation-focused lens to consistently compose designs and execution strategies that realize value for patients and Lilly’s portfolio.  The Neurodegeneration & Pain Design Hub is one arm of the Lilly DH, which also has teams for Diabetes, Immunology, and Oncology.  The DH seeks to deliver a core clinical design capability with tightly integrated cross-functional expertise to provide consistent, high quality designs to Asset Teams.  Cross-therapeutic and cross-functional sharing of knowledge are key objectives of the hub.The OpportunityLilly is seeking a strategic Clinical Research Physician (CRP) to serve as the key scientific leader within the Neurodegeneration & Pain Design Hub.  In this role he/she will provide scientific, clinical, and therapeutic expertise and leadership for all assets within Lilly’s early through late phase development programs.  Through application of scientific training, clinical expertise, and relevant experience, he/she will play a key role in the development of corporate/global clinical trials.  The CRP will also participate in the review of protocols and publications and as needed work with regulatory and other governmental agencies.  He/she will participate, at times, in activities largely led by the Asset Teams such as 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 physician must have deep understanding of neurology/pain, clinical study design, and research.  He/she must also be aware of novel design and execution paradigms, and be willing to interact and learn from different teams, including different therapeutic areas. 

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

 Clinical Planning and Clinical Trial ProtocolsOffer expert consultation to Business Unit or Research teams in development of their Clinical Program plans.  DH input will emphasize the systematic consideration of clinical trial or program design options and be clear about implications and trade-offs between these options, in order to facilitate informed decisions by governance committees.Lead efforts to design/develop clinical study protocols aligned with the product lifecycle plan and clinical strategy to address key customer needs (patient, regulator, prescriber, and/or payer).  The DH CRP will collaborate with Asset Teams in developing and crafting these protocols.Provide clinical leadership and insight to DH activities, bringing systematic consideration of impact to execution speed/efficiency in the design of protocols and clinical trial packages.Engage appropriately with the asset teams and some of their external activities in order to have deep understanding of their patients, medical and payer communities, and business strategy.Contribute global alignment of portfolio clinical strategy and the associated asset-specific clinical plans.Closely collaborate with asset teams and execution teams to understand the impact of design on speed to protocol approval. Work with other DH staff to analyze experience and improve approaches.Clinical Research/Trial Packages, Execution and SupportCollaborate with clinical research staff on design and conduct clinical trials (e.g., sample size, patient dedication, timelines, grants, and governance review interactions).Review risk profiles to ensure appropriate communication of risk to study subjects.Contribute to investigator identification and selection, in conjunction with Design Hub and clinical teams.Support flawless transition of protocols from design to execution.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.Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on an international basis.Develop and maintain appropriate collaborations and relationships with relevant professional societies.Participate in developing scientific data dissemination, and preparation of final reports and publications.Scientific / Technical Expertise and Shared LearningCritically 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.Analyze current trends and projections for clinical research, practice, and access in the therapeutic area(s) relevant to the product.Focus on organizational learning to identify standard methodologies, delivering these as systemized standard approaches with ultimate goal to make program and protocol design faster and less expensive. This will require cross-TA sharing within the hub and structured efforts to understand and benefit from our repeated, ongoing experiences.Ensure drug development shared learning amongst colleagues within and outside of the DHWork closely with counterparts in other TAs to continue to evolve Lilly standards, tools and standard methodologies across development.QualificationsMedical Doctor or Doctor of Osteopathy. Must be board eligible or certified in a medical specialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.Non-U.S. 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.htmAdditional Skills/PreferencesClinical research or pharmaceutical medicine experience that is adequate to provide strong grounding in the drug development process, clinical trial principles, and scientific decision making.  Ideally this experience will have accrued in an industry or academic setting.Strong understanding of neurodegeneration and/or pain – pathology, pathophysiology, unmet needs, and treatment standards.Expertise in one or more areas relevant to clinical trial design are strongly preferred (e.g., statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, etc.).Fluent in English; both written and verbal communications.Interpersonal, negotiation and organizational skills.Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.Excellent collaboration skills.Willing to engage in limited domestic and international travel to the degree appropriate to support the business of the team.Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

 

 

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