This individual will be responsible for supporting global clinical development strategies and providing clinical support for global hematology programs across Spark. This will include contributing to program/trial development, protocol development, serving as Medical Monitor of clinical studies, site selection and enrollment, investigator engagement, site training, etc. This role will be responsible for developing plans that deliver medically differentiated therapies that provide meaningful improvements to patients. This lead will provide clinical support and guidance into global clinical development strategies ensuring effective and efficient execution. This role will also provide clinical guidance for regulatory interactions, and will assist the Medical Affairs team, as necessary, providing clinical support for strategic planning activities (including clinical advisory boards). S/He/They will serve as a scientific, medical and strategic expert both internally and externally.
Lead the design of global clinical trial protocols and support timely execution of all hematology clinical programs
Serve as the Medical Monitor for clinical studies, conducting ongoing review of medical/safety data and ensuring correct medical/scientific data interpretation for study reporting
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
Participating as standing and/or ad hoc member of sub-teams relevant to hematology clinical programs as the clinical lead, supporting cross-functional integration, coordination and alignment to enable effective and efficient clinical development plan execution
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.)
Acts as a regular reviewer/presenter to various internal committees
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.
Organize and execute clinical advisory boards to enhance the hematology programs.
Initiate and develop professional relationships with external clinical opinion leaders, investigators, and consultants and stay abreast of competitive intelligence and other market/industry activities
Maintains highest standards and levels of scientific and clinical knowledge in disease area of hematology
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 guidance to commercial and global teams, as needed. Participate in advisory boards, support global initiatives; attend scientific meetings/present data as needed
Drives and integrates ongoing evidence/data generation, including clinical trials, Medical Affairs studies, Real World Evidence, and other types of evidence.
Education and Experience Requirements
Board-certified M.D. with relevant medical experience in hematology required
3 or more years pharma/biotech industry experience OR is a recognized expert in the field. A minimum of years industry experience is preferred
Experience managing medical/clinical staff
3 or more years’ experience with clinical trials
Experience submitting NDAs/BLAs to regulatory authorities in Europe and/or the U.S.
Proven success executing global clinical development plans
Experience publishing results of clinical drug trials in referred journals
Solid understanding of Phase I – IV drug development
Multidisciplinary experience in the pharma/biotech industry is strongly preferred (e.g., research, regulatory, clinical operations, business development, commercial operations, etc.)
Strong academic/teaching background is preferred
Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
Comprehensive understanding of product and safety profiles
Knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
In-depth understanding of competitive activity in the field
Key Skills, Abilities, and Competencies
Strong knowledge 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
Ability to stay abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease areas
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
Internal and External Contacts
- Ability to critically evaluate scientific literature
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 (approximately30%)
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.