MEDICAL DIRECTOR / MEDICAL SCIENCE DIRECTOR

Position Summary:

The Associate Medical Director/Medical Director, Clinical Development will be an essential 

contributor to the scientific, clinical, and operational scope of clinical development programs. 

The Associate Medical Director/Medical Director, Clinical Development will drive the design, 

planning, and implementation of study protocols for assigned investigational products and 

will play a key role in supporting related regulatory activities. This role will work on 

cross-functional program development and study management teams for the design, 

execution, and monitoring of clinical trials, as well as assist with data interpretation and 

communication to both internal and external stakeholders. This individual may also help 

support internal process improvement initiatives within the clinical department.

Essential Duties and Responsibilities:

Specific responsibilities for this role will include but are not limited to:

•Author protocols and contributes to authoring of clinical study reports, IBs, ICFs, training 

 documents, and other clinical and regulatory documents.

•Develop and deliver presentations, both internally and externally, to convey the Medical Affairs 

  perspective and provide updates on activities relevant to assigned portfolio or therapeutic 

  area

•Represent Medical Affairs as a standing member of appropriate Cross functional teams

•Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in 

  support of program-level development strategy as well as clinical trial objectives; responds

  to or triages questions for appropriate escalations.

•Contribute to the development and execution of a strategic publication plan for assigned 

  molecules

•Develop medical education strategy for independent and company-sponsored educational 

  activities

•Support planning and execution of Advisory Boards

•Attend and contribute at major scientific and medical conferences

•Provide Medical Affairs input into competitive intelligence activities and projects

Qualifications

Education/Experience:

•At least 3 years of experience at a pharmaceutical, CRO or biotechnology company as a clinical 

  scientist or related role - title will be commensurate on experience.

•MD or MD/PhD with experience in patient care at the graduate medical level and beyond.

•Experience in nephrology or oncology clinical trials preferred. Early drug development 

  experience highly desirable.

•Experience with data analysis and interpretation as an understanding of safety and 

  pharmacovigilance principles required.

Professional and Personal Requirements:

•Ability to think strategically, innovatively, and tactically with an interest in clinical research

  and drug development.

•Demonstrated ability to evaluate, interpret and present complex scientific data (preclinical, 

  clinical, translational) to inform scientific hypotheses and development strategy. Working 

  knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.

•Must be willing and possess the expertise to work effectively in a fast-paced, team-based 

  matrix environment as well as the ability to function independently as appropriate. Flexible 

  to accommodate changes in team and project needs.