Medical Director, Clinical Development - 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

75% of Time

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% of Time

Provide input to Medical Affairs regarding global publication and launch plans and participate in development of materials (slide decks, posters, manuscripts, abstracts), based on clinical trial data.

Participate in development, review and/or presentation of clinical data in Training, Managed Care, or other presentations, as needed.

Provide hematologic expertise to commercial and global teams, as needed. Participate in advisory boards, support global initiatives; attend scientific meetings/present data as needed.

Other duties as assigned or as business needs require.

Education and Experience Requirements

• MD (or MD/PhD) degree or equivalent and demonstrated depth and breadth of knowledge and experience in clinical research in the academic, clinical practice, or industry setting.
• Board certification in Hematology and/or drug development experience in Hematology.
• Minimum of 5 years pharmaceutical and/or clinical experience; global experience a plus.
• Prior Clinical Development experience in hematology and prior experience in conducting clinical research preferred.
• Proven scientific writing skills and exceptional communication skills. Proven leadership skills with ability to defend the clinical development plan in front of strategic and technical governance committees.
• Proven ability to function effectively across a complex matrix organization with multiple stakeholders and constituents, with the expertise and the gravitas to align.

Key Skills, Abilities, and Competencies

• Understanding of the drug development and approval process and clinical trial design;
• Strong communication skills (written and oral); Excellent presentation skills required.
• Capable of representing Spark professionally with external global opinion leaders, investigators, vendors, regulatory agencies, alliance partners, and others.
• Able to effectively engage with investigative sites and personnel.
• Ability to work effectively cross-functionally, and to serve as a clinical resource within Spark.
• Ability to mentor and develop staff with regard to clinical and strategic issues.
• Strong interpersonal and leadership skills required.
• Computer literacy (Microsoft Office).

Complexity and Problem Solving

• Self-motivated and detail-oriented with the ability to prioritize and handle multiple projects simultaneously.
• Ability to plan and think strategically and critically.
• Ability to function as mentor and develop junior staff.
• Ability to critically evaluate scientific literature.

Internal and External Contacts

This role will interact on a regular basis with a variety of internal and external colleagues, including (but not limited to): other internal clinical, non-clinical, regulatory, medical, safety, R&D, and commercial personnel, external vendors (CROs, labs), investigators and investigative sites, consultants, global key opinion leaders, and global regulators.

Other Job Requirements

Global travel required (approximately 35%).