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Clinical Development Lead-Internal Medicine
Job Opportunity at
Spark Therapeutics, Inc
Posted on Jun 28
To define global clinical strategy and provide medical support for all global internal medicine clinical research and development activities related to the neuromuscular and lysosomal storage disease clinical programs (e.g., clinical program/trial development—all phases of development, medical and safety assessments) and global regulatory interactions.
To assist the Medical Affairs team (when necessary), providing medical expertise and insight into clinical development programs to global medical and commercial teams.
To provide medical/clinical support in strategic planning activities and to assist in evaluations of new business development opportunities.
Independently develop recommendations on potential new clinical development programs and projects based on medical need and development requirements; lead the design of global clinical development programs and clinical trial protocols and ensure timely execution of all clinical programs related to neuromuscular and lysosomal storage diseases.
Participate in product development and governance teams and sub-teams as clinical lead.
Provide medical guidance to other R&D groups as needed, regarding dose selection, endpoints, 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, consultants, advocacy groups, and others. Work closely with experts to design, develop and advance clinical program.
Function as medical expert for global regulatory interactions; collaborate with Regulatory Affairs in planning regulatory strategy and communications.
Capable of authoring position papers, protocols, study reports, regulatory documents (NDA, MAA responses, clinical summaries, safety assessments, etc); participate in review of clinical and regulatory documents, during preparation, submission, and defense.
Function as Sponsor representative and participate in joint committees with external alliance partners, as needed.
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 medical expertise to global commercial teams, as needed.
Participate in advisory boards, support global initiatives; attend scientific meetings, as needed.
Serve as internal resource/reviewer and expert in neurology for Corporate Communications personnel and other functional areas, as needed.
Able to critically evaluate new business opportunities and potential new product candidates from a clinical/safety perspective; participate in due diligence activities.
Other duties as assigned or as business needs require.
Comprehensive 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.
Ability to work effectively cross-functionally, and to serve as a medical/clinical resource within Spark.
Ability to mentor and develop staff with regard to medical, clinical and strategic issues.
Strong interpersonal and leadership skills required.
Computer literacy (Microsoft Office).
MD/DO degree required, internal medicine training and clinical practice preferred, board certification preferred.
Minimum of 10 years pharmaceutical and/or clinical experience; global experience preferred.
Prior pharmaceutical experience in rare disease, glycogen/lysosomal storage diseases, neuromuscular diseases (Medical Affairs or Clinical Development), and prior experience in conducting clinical research preferred; gene therapy, cellular therapy, and/or biologics experience a plus.
Proven track record of successfully conducted clinical trials and regulatory approvals.
WHO WE ARE:
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
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