Director- Clinical Research Scientist – Medical Affairs

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The Clinical Research Scientist (CRS) within Medical Affairs provides scientific and clinical expertise to support product strategy and execute medical plan tactics, customer engagement, and evidence generation. This role ensures that medical insights, clinical data, and regulatory considerations are integrated into local business activities and global development plans.

• Business & Customer Support
  • Anticipate and respond to scientific and clinical information needs from healthcare providers, payers, and patient groups.
  • Lead data analyses and health outcomes research to address customer questions.
  • Contribute to medical strategy and brand planning in collaboration with global Medical Affairs, GPO/RWE, PRA, and commercial partners.
  • Provide medical expertise for payer partnerships, promotional material review, and business-to-business/government engagements.
  • Support training of sales, medical, and patient support teams.
  • Lead definition of Patient Journey and contribute clinical perspective to patient programs.
  • Participate in relevant professional and industry associations.
• Scientific Exchange & Data Dissemination
  • Ensure compliance with global and local regulations governing scientific communication.
  • Address unsolicited scientific inquiries in alignment with medical governance standards.
  • Support scientific meetings, advisory boards, symposia, and other expert engagements.
  • Prepare or review medical letters, slide decks, abstracts, posters, and manuscripts.
  • Build and maintain relationships with key opinion leaders and scientific societies.
  • Represent the company at medical congresses and support scientific booth activities.
  • Contribute to data analyses, publication development, and Clinical Trial Registry reporting.
• Clinical Planning
  • Align clinical strategies with regional needs by collaborating with Medical Affairs and global development teams.
  • Communicate local research needs to ensure Phase III–IV programs reflect market and customer requirements.
  • Maintain up-to-date understanding of clinical and competitive data.
  • Provide regional clinical insights to inform development plans and study protocols.
• Clinical Research Execution
  • Review and approve informed consent documents to ensure accurate risk communication.
  • Partner with clinical operations, statisticians, and investigators throughout study design, initiation, conduct, and close-out.
  • Support investigator/site training and address study-related medical questions.
  • Oversee local safety monitoring and adverse event follow-up.
  • Review investigator-initiated trial (IIT) proposals as needed.
  • Ensure global alignment of Phase 3b/4 and applicable early-phase studies.
• Regulatory Support
  • Contribute to development and review of local labeling and labeling changes.
  • Provide medical input for regulatory submissions, advisory committee preparation, and local registration activities.
  • Participate in risk management planning with global and local teams.
• Scientific & Professional Development
  • Stay informed on therapeutic area trends, market changes, and competitive landscape.
  • Provide scientific training to clinical study teams and act as a protocol subject‑matter expert.
  • Represent the organization at medical congresses and contribute to medical budget planning.
  • Seek opportunities for external scientific engagement.
• Leadership & Collaboration
  • Set and pursue professional development goals and support growth of colleagues and direct reports.
  • Contribute to recruitment, diversity, and retention efforts when applicable.
  • Participate in committees, Six Sigma initiatives, and cross‑functional projects.
  • Model leadership behaviors and serve as an ambassador for patients and the company.
• Primary Internal Interactions Include, But Not Limited To
  • Therapeutic area directors, managers, or project managers
  • Product directors, managers, and associates of the brand
  • Clinical research staff
  • Statisticians
  • Scientific communication associates
  • Medical information associates
  • Medical liaisons
  • Global patient outcomes research consultants/research scientists and health outcomes liaisons
  • Regulatory…