Senior Clinical Development Medical Director

Role Summary

Senior Clinical Development Medical Director (CDMD) leading strategic planning and execution of clinical programs in cardiovascular anticoagulation; overseeing end-to-end clinical development for assigned programs; fostering empowerment, agility, and collaboration within a matrixed environment.

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
• 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; 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
• Experience contributing to all aspects of conducting clinical trials (planning, executing, reporting, publishing) in a global/matrix pharmaceutical environment
• Working knowledge of disease area with ability to interpret and present efficacy and safety data and to understand clinical 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, including matrix environments

Skills

• Strategic medical leadership
• Cross-functional collaboration in global/matrix settings
• Clinical development planning and protocol review
• Data interpretation and scientific communication
• Safety oversight and SMT collaboration
• Regulatory document development for trials and programs

Education

• MD or equivalent medical degree

Additional Requirements

• None specified beyond qualifications