Medical Director, Hematology

Primary Duties

This individual will aid in defining global clinical strategy and provide clinical support for all global hematology (and other therapeutic areas as necessary) programs in clinical R&D (eg, program/trial development, site selection and enrollment, investigator engagement, site training, clinical operations). S/he will provide clinical support and input into global regulatory interactions and serve as the clinical lead for scientific publications and medical communications.  This role will also provide clinical support for strategic planning activities (including clinical advisory boards). S/he will serve as primary clinical liaison with the investigative sites to ensure timely clinical trial enrollment and execution.  This individual will lead individual study teams and serve as the functional representative on cross-functional strategy teams in research and development.

• Leads design, implementation, and interpretation of the global clinical program for a drug candidate to deliver a successful regulatory submission worldwide through regulatory submission and approval.
• Supports and contributes to strategic clinical planning for early development candidates with an emphasis on effective transition of early candidates into development and/or external BD (Business Development) opportunities.
• Conducts technical review of licensing opportunities, including due diligence activities.
• Provides innovative options to design and execute clinical programs.
• Accountable for operational excellence and timely production and approval of quality clinical deliverables, including clinical plans, protocols, clinical study reports and regulatory submission documents (e.g., NDA, MAA, AR, briefing documents, investigator’s brochures) and,
• Develops global congress abstracts or manuscripts intended for external publication that based on clinical trial data

Responsibilities

% of Time

Job Function and Description

75%

Drive strategy and provide insight for potential new clinical programs and projects based on medical need and development requirements; lead the design of global clinical programs and clinical trial protocols and ensure timely execution of all hematology clinical programs

Organize and execute clinical advisory boards to enhance the hematology and liver programs.

Provide clinical guidance to other R&D groups as needed, regarding nonclinical support, subject eligibility, adverse events, investigator questions, regulatory requests, statistical analyses, study design and conduct, etc.

Initiate and develop professional relationships with external clinical opinion leaders, investigators, and consultants

Serve as clinical liaison with investigative sites; engage and support clinical trial sites, including education and training. Participate in site selection activities (including feasibility and initiation visits; other site visits as required) and other trial-related activities to achieve enrollment targets and study timelines

Serve as internal as clinical expert for global regulatory interactions; collaborate with Regulatory Affairs in planning regulatory strategy and communications

Participate in development and review of clinical documents, including position papers, protocols, study reports, regulatory documents (NDA, MAA responses, clinical summaries, safety assessments, etc)

 

25%

Provide input to Medical Affairs regarding global publicatio