CRP Medical Development-Obesity

Role Summary

Development Clinical Research Physician (CRP) in obesity, responsible for leading the development, conduct, and reporting of global clinical trials to support product registration and commercialization. Provides medical leadership across trial programs, ensures regulatory and ethical compliance, and supports data dissemination, regulatory interactions, and strategic planning for the product.

Responsibilities

• Clinical Planning
• Collaborate with regional and cross-functional teams to develop and maintain a Draft Launch Label and Value Proposition addressing patient, provider, and payer needs; define product lifecycle plans, clinical strategies, development plans and study protocol design.
• Contribute to business unit and global alignment of clinical strategy and plans.
• Understand and stay updated with pre-clinical and clinical data relevant to the molecule.

• Clinical Research/Trial Execution and Support
• Plan, collaborate on, and review scientific content of protocols, informed consent documents, final study reports, and submissions according to project timelines.
• Provide oversight and input into ICDs.
• Collaborate in design, conduct, and reporting of local clinical trials (sample size, patient commitment, timelines, grants, governance).
• Review and approve risk profiles and ensure appropriate communication of risk to study subjects.
• Participate in investigator identification and selection with clinical teams.
• Ensure completion of administrative requirements for study initiation and conduct in line with GCPs and local laws.
• Assist in planning and participate in study start-up trainings for investigators and site personnel.
• Serve as a resource to study personnel, monitors, investigators, and ethics boards for questions and issues during conduct.
• Address scientific information needs of investigators and personnel.
• Monitor patient safety and track adverse events per corporate safety policies.
• Review IIT proposals and publications as requested.

• Scientific Data Dissemination/Exchange
• Ensure compliance with laws and policies governing data dissemination and external interactions.
• Address unsolicited scientific information needs of external professionals per guidelines.
• Participate in reporting trial data to registries; support planning of symposia, advisory boards, and related meetings.
• Support medical information materials and respond to customer questions or media requests.
• Support data analysis and development of slides and publications; establish collaborations with experts and societies; support training of medical personnel.
• Provide congress support and participate in data dissemination activities.
• Contribute to customer research design as medical expert and support medical personnel training.

• Regulatory Support Activities
• Participate in label changes and labeling modifications with affiliates, regulatory, and legal teams; provide medical expertise to regulatory scientists.
• Assist in preparing regulatory reports and interactions (NDAs, FDA reports, PADERS, advisory committee preparations, local registrations) from a global perspective.
• Participate in advisory committees and risk management planning with affiliates and GPS.

• Business/ customer support (pre- and post-launch)
• Contribute to medical strategies to support brand commercialization; address scientific information needs of payers, patients, and providers.
• Lead data analyses and outcomes research to address customer questions; collaborate with regional marketing to support demand realization.
• Maintain contacts with external experts and thought leaders; provide clinical input to payer programs and product value defense.
• Support B2B/B2G activities as medical expert; contribute to strategic brand planning and to development/review of promotional materials as needed.
• Define the Patient Journey and Moments of Truth; participate in trade associations as appropriate.

• Scientific / Technical Expertise and continued development
• Remain current with relevant literature and data on competitive products; monitor trends in clinical practice and access in relevant therapeutic areas.
• Provide scientific training to the clinical study team; act as protocol expert and scientific consultant; pursue extramural scientific opportunities; attend scientific symposia.

• General Responsibilities
• Support management in budget preparation and administration; pursue professional development and contribute to the development of others.
• Participate in recruitment, diversity, and retention efforts; collaborate with alliance, business, and vendor partners.
• Provide timely feedback to colleagues; participate in committees, Six Sigma initiatives, and task forces.
• Maintain qualifications and training and model leadership behaviors; act as an ambassador for patients and the brand.

Qualifications

• Required: Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed comparable post-medical-school clinical training relevant to the country of hiring. US-trained physicians must have board eligibility or certification.
• Required: 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.
• Required: Non-US trained physicians must have completed education and training at a medical school meeting LCME requirements.

• Preferred: Clinical research or pharmaceutical medicine experience; obesity medicine clinical experience; at least 3 years of industry experience.