Clinical Research Medical Director, Cardiometabolic

Role Summary

Clinical Research Medical Director, Cardiometabolic

Responsibilities

• Provide clinical/scientific input during the development and execution of clinical trials
• Interpret clinical trial data
• Participate in safety assessments
• Participate in interactions with regulatory agencies
• Author CSRs, publications and regulatory submissions
• Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL
• Identify new clinical research opportunities
• Support in-licensing and out-licensing activities and partner relationships
• Support product lifecycle management for new indications as directed by Global Development Leader
• Provide clinical content input to: regulatory interactions and documents, safety interactions and documents, materials to be used in Scientific Affairs, and materials to be used by the Commercial Organization

Qualifications

• Basic Qualifications: MD or DO degree from an accredited medical school
• AND
• 2 years of clinical research experience and/or basic science research
• Preferred Qualifications:
  • Three (3) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
  • Five or more years of clinical research experience and/or basic science research combined with clinical instructing and patient care activities
  • Strong and versatile clinical development experience in endocrinology or cardiology and accreditation in relevant sub-specialty
  • Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes
  • Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1, 2 and/or 3 clinical trials in obesity or diabetes
  • Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
  • Leadership experience/potential as a medical expert in a complex matrix environment
  • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
  • Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path

Skills

• Clinical development and trial design
• Regulatory and safety affairs
• Stakeholder engagement and collaboration
• Scientific communication and publication
• Leadership in a matrix environment

Education

• MD or DO degree from an accredited medical school

Additional Requirements

• None beyond those listed in Qualifications