Clinical Design Physician Neuroscience (M.D.)

Responsibilities

• Translate therapeutic area and asset team strategy into clear objectives and associated clinical development program and trial optionality.
• Represent program and trial design optionality to asset teams and Sr. Leaders to inform prioritization of an option that will be translated into a clinical protocol(s).
• Bring the medical/clinical perspective to the Design Team to inform the design of study protocols and in partnership with the other functions (e.g. Asset Team, BU Development Team).
• Contribute to the development of asset strategy (e.g., identification of target patient population) in partnership with the asset team.
• Contribute to business unit and global alignment of portfolio clinical strategy and the associated asset-specific clinical plans including main indication and line extensions.
• Collaborate and complement clinical research staff in the design and conduct of clinical trials (e.g. sample size, patient commitment, timelines, grants, and governance review interactions).
• Support investigator identification and selection, in conjunction with Clinical Development.
• Partner with Clinical Development to accelerate participant recruitment and retention efforts – especially considering how design elements can create value in these areas.
• Support seamless transition of protocols from design to execution.
• Knowledge of and compliance with local laws and regulations, global policies and procedures, and compliance guidelines with respect to data dissemination and interactions with external health care professionals.
• Develop and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community.
• Participate in development of scientific data dissemination and preparation of final reports and publications related to assets and/or support efforts to influence clinical design science within the industry.
• Critically read, evaluate, and apply the relevant medical literature, status and data from competitive products, and updates with medical and other scientific developments relevant to the therapeutic area, disease state, and product.
• Engage appropriately with the asset teams and the business unit development teams on relevant external activities to have good understanding of their patients, medical and payer communities, and business strategy.
• Apply the above to the optionality recommended for clinical programs and trials and when supporting other medical-related areas as assigned.

Requirements

• 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.
• 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).
• Board certification or eligibility within Neuroscience or related area strongly preferred.
• Three (3) years of clinical research experience in the therapeutic area.
• Strong understanding of therapeutic area pathology, pathophysiology, unmet needs, and treatment standards in major geographies (e.g. US, EU, Japan, China, etc).
• Strong foundation in statistical science, including Bayesian statistics, as applied to study design (e.g., sample size determination, setting of critical success factors).
• Ability to communicate effectively with statisticians and help translate complex principles to inform design optionality and protocols.
• Global / multi-national design or development experience.
• Willing to relocate to Indianapolis. If unable to relocate, demonstrated ability to work with high effectiveness from a remote location in a hybrid environment.
• Willing to engage in limited domestic and international travel to the degree appropriate to support the business of the team.
• Fluent in English, with strong communication skills, verbal and written.
• Strong interpersonal, organizational, and negotiation skills.
• Ability to influence others (both cross-functionally and within the function) to advance objectives.
• Understanding of how design elements translate into delivery. Bias for simplifying, reducing burden, and creation of value through excellent design.
• Strong communication skills demonstrated in a variety of modalities (e.g. presentations, meetings, creation of protocols and regulatory documents) and with broad set of stakeholders (e.g. team leaders, Sr. Leader decision makers, medical and non-medical counterparts, thought leaders, investigators, regulators).
• Experience routinely using AI to accelerate deliverables.