Associate Medical Director Clinical Development Hematology
About The Position
Seeking a physician with 3-5 years of clinical research or clinical trials experience in industry or equivalent experience in academia or hospital system. The primary role is to work within the Hematology/Nephrology Clinical Development Department. This individual will serve as a medical monitor for the assigned study(ies) which are typically phase 1-4 clinical trials, or other studies as directed by the line management. This position additionally offers substantial opportunities for regulatory and commercial interactions and career advancement in the fast-moving area of rare disease.
Requirements
- Medical doctor (MD) or foreign equivalent physician education
- History of industry, academic or hospital-based clinical or basic science research
- 1-2 years of industry experience
- Excellent written / oral communication skills
- Ability to think strategically
- Attention to detail
- Interest in career progression and taking and willingness to take on new responsibilities
Nice To Haves
- Formal training or education in clinical trials, epidemiologic design, statistical methods and/or quantitative sciences.
- Master degree in clinical research or related field preferred
- Previous clinical trial experience as medical monitor in industry setting
- Safety medical monitoring and reporting experience
- Protocol development experience
- Understanding of regulatory requirements related to clinical trials e.g. FDA, EMA, MHRA
- Publication in peer reviewed journals
- Presentation of conference abstracts in international conferences
Responsibilities
- Medical Expert for clinical study team
- Medical Monitor for the assigned trials or studies
- Medical Data Review
- Protocol development from concept to final protocol
- Protocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoring
- Strategic guidance to phase II/III development programs and oversight of global clinical trials/trial team (s) on assigned program(s)
- Presentation at academic congresses, investigator meetings and advisory meetings
- Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents
- Particiapte in or lead ad hoc clinical development projects as directed by line management
Benefits
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
