Clinical Design Physician Neuroscience; M.D

Clinical Design Physician

The primary responsibilities of the Clinical Design Physician are focused on the design of Phase II to Phase IV clinical programs and studies within the neuroscience therapeutic area.

• As the Medical leader on a cross‑functional Clinical Design team, translate therapeutic area and asset team strategy into clear objectives and associated clinical development program and trial optionality. Optionality will address business and customer needs (patient, prescriber, payer, and/or regulator); be in alignment with phase of product lifecycle; and clearly articulate associated tradeoffs in value (data generated, risks created/discharged, cost, and time).
• Represent program and trial design optionality to asset teams and Senior Leaders to inform prioritization of an option that will be translated into a clinical protocol(s). Adjust optionality in accordance with feedback from leadership.
• 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).
• Provide insight into impact of study/protocol design features to feasibility, value, patient and investigator burden, and execution speed/efficiency.
• 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).
• Understand how design elements influence the ability to deliver on new regulatory expectations (e.g. decentralization of clinical trials, increase racial and ethnic diversity in clinical trials) and clinical capabilities (e.g. value‑based, patient accessibility, patient burden).
• Review risk profiles to ensure appropriate communication of risk to study subjects via the protocol.
• 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.
• Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community.
• Develop and maintain appropriate collaborations and relationships with relevant professional societies, conferences, and consortia.
• 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.
• Be aware of current trends and projections for clinical research, practice, and access in the therapeutic area(s) relevant to the 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.

• Focus on organizational learning to proactively identify, apply, and share best practices and…