Clinical Development Medical Director - Cardiovascular

Role Summary

Clinical Development Medical Director - Cardiovascular

Responsibilities

• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
• Leading development of clinical sections of trial and program level regulatory documents
• Driving execution of the assigned clinical program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable
• Supporting (Senior) Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team (SMT), supporting overall program safety reporting in collaboration with Patient Safety colleagues
• Supporting the Clinical Development Head (CDH) and GPCH by providing medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP) and Clinical Trial Protocol (CTP) reviews, and contributing to/driving development of disease clinical standards for new disease areas
• As a medical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards

Qualifications

• MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area; Clinical practice experience 4 years (including residency) and board certification or eligibility in disease area preferred
• Extensive experience in clinical research or drug development
• Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required
• Experience of contributing to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry required
• Working knowledge of disease area is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports
• Demonstrated ability to establish effective scientific partnerships with key stakeholders
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
• Previous global people management experience is preferred, though this may include management in a matrix environment

Skills

• Clinical leadership and strategic medical input for clinical deliverables
• Regulatory documentation development and trial protocol review
• Cross-functional collaboration in a global/matrix setting
• Safety oversight and or SMT collaboration
• Data interpretation and communication of efficacy and safety data
• GCP, trial design, statistics, and regulatory knowledge

Education

• MD or equivalent medical degree; board certification or eligibility in disease area preferred