Clinical Research Physician - Development

Role Summary

Development Clinical Research Physician (CRP) participates in the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; monitoring and reporting of adverse events; review of protocols, study reports, publications and data dissemination; regulatory interactions; external medical outreach; and development of business unit and global strategy for the product. The CRP serves as a scientific resource for study teams and other stakeholders and ensures activities comply with local and international regulations, GCPs, and company policies.

Responsibilities

• Clinical Planning
• Collaborate with regional units and cross-functional teams to develop and maintain Launch Label and Value Proposition; 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
• Plan, collaborate on, and review scientific content of clinical documents (protocols, informed consent, final study reports, submissions) per project timelines.
• Provide oversight and input into ICDs
• Collaborate with clinical research staff in design, conduct and reporting of local clinical trials (sample size, timelines, governance, etc.)
• Review and approve risk profiles to ensure appropriate communication of risk to study subjects
• Participate in investigator identification and selection with clinical teams
• Ensure operational teams document administrative requirements for study initiation and conduct per GCPs and local laws
• Assist in planning and participate in study start-up meetings; provide training to investigators and site personnel
• Serve as resource to clinical operations, monitors, investigators, and ethics review boards
• Address scientific information needs of investigators and personnel
• Monitor patient safety and track/report adverse events per patient safety policies
• Review IIT proposals/publications as requested
• Scientific Data Dissemination/Exchange
• Ensure compliance with laws/regulations and global policies for data dissemination and external interactions
• Address unsolicited scientific information needs of external healthcare professionals
• Participate in reporting clinical trial data to registries
• Support planning of symposia, advisory boards, and meetings with healthcare professionals
• Support medical information in preparation/review of medical letters and information materials
• Prepare/review scientific information in response to questions or media requests
• Support data analyses, slide sets, and publications
• Establish collaborations with external experts, thought leaders, and medical community
• Develop relationships with professional societies
• Support design of customer research as medical expert
• Support training of medical personnel; provide congress support
• Participate in data analysis, dissemination, and preparation of final reports/publications
• Regulatory Support Activities
• Participate in development/review of label changes; provide medical expertise to regulatory scientists
• Support regulatory reports and preparations for regulatory meetings; participate in advisory committees
• Risk management planning with affiliates and Global Patient Safety
• Business/customer support (pre- and post-launch)
• Contribute to medical strategies to support brand commercialization; collaborate with cross-functional teams
• Understand and anticipate scientific information needs of Development customers
• Address customer questions with data analyses and outcomes research
• Collaborate with regional marketing to support demand realization
• Maintain contact with external experts and thought leaders
• Contribute to payer partnership programs and defend product value
• Active contribution to strategic brand planning
• Scientific/Technical Expertise and Development
• Critically evaluate medical literature; stay updated on developments relevant to the product
• Be aware of trends in clinical practice and access in relevant therapeutic areas
• Provide scientific training for the clinical study team
• Act as scientific consultant and protocol expert for study teams
• Explore opportunities for external scientific experiences; attend scientific symposia
• General Responsibilities
• Support budget preparation/administration for the development unit
• Set and meet professional development goals; contribute to the development of others
• Participate in recruitment, diversity, and retention efforts
• Collaborate with alliance, business, and vendor partners
• Provide coaching and feedback to team members; participate in committees and process improvement initiatives

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 board eligibility or certification. Foreign-trained physicians may be hired depending on location and guidance.
• Non-US trained physicians must have completed education and training from an LCME-approved medical school; see local licensing guidance for specifics.

Additional Requirements

• Clinical research or pharmaceutical medicine experience (preferred)
• Specialization in dermatology or allergy and immunology (preferred)
• At least 3 years of global clinical development experience (preferred)
• At least 3 years of pharmaceutical industry experience (preferred)
• Demonstrated knowledge of the drug development process
• Fluent in English (written and verbal)
• Strong communication, interpersonal, organizational, teamwork, and negotiation skills
• Ability to influence cross-functionally to create a positive working environment
• Ability to travel domestically and internationally as needed to support the team