Associate Medical Director Clinical Development Hematology

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.

You will be responsible for:

• 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

You will need to have:

• 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

• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• 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