Head of Clinical Development
Job Opportunity at Spark Therapeutics, Inc

Posted on Feb 19

http://www.sparktx.com    215-220-9300

Location: Philadelphia, PA
Job Type: Full Time
Job ID: W4148748

The Head of Clinical Development is responsible for defining the vision and clinical strategies that will support Spark’s product development and commercialization objectives, and for the design and successful execution of clinical trials. S/he will take a leadership role in analysis and interpretation of clinical results for regulatory submissions and publications, and will provide medical/clinical support in strategic planning activities and will assist in evaluation of new business development opportunities.
  • Design clinical trials for the purpose of meeting specific objectives; able to anticipate and address future commercial and clinical development needs
  • Lead and motivate the clinical operations team to effectively and efficiently operationalize the clinical development strategy (ie, clinical trials management)
  • Partner with internal and external experts and consultants to refine the clinical development plan and to optimize the scientific integrity of the methodology and ensure the safety of clinical subjects; ensure that the overall scientific and medical content of all clinical programs is sound
  • Participate in /lead clinical study teams, product development and/or product strategy teams, as needed
  • Review, analyze and interpret the results of clinical programs in collaboration with relevant experts; design and lead formal presentations of results internally and to the medical community in written, verbal and visual formats
  • Provide medical/clinical input into and review of regulatory documents, during development, submission, and defense
  • Support clinical and cross-functional initiatives to improve the quality of all clinical programs and to effectively advance the R&D portfolio
  • Provide medical expertise to global commercial and Medical Affairs teams, as needed. Participate in advisory boards, support global initiatives; attend and participate (present results) in scientific meetings as needed
  • Serve as internal resource/reviewer and medical/clinical expert 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 evaluations and due diligence activities
  • Provide medical/clinical insight into competitive developments
  • Other duties as assigned

  • Advanced understanding of clinical medicine, clinical pharmacology, and associated disciplines (eg, biostatistics) drug development principles; demonstrated experience in all developmental phases, including evaluation of non-clinical data
  • Experience with designing and running multiple clinical trials; able to speak to the strategy of the clinical development plan
  • Demonstrated ability to manage and motivate internal and external team members
  • Strong written communication and presentation skills
  • Proficient in Microsoft Office applications

  • MD/DO, or PhD in life sciences; significant experience in a therapeutic area of interest to Spark is valuable (eg, immunology, CNS/neurology, ophthalmology, hematology)
  • Minimum of 12+ years of global pharmaceutical/clinical research experience, including clinical operations experience
  • Prior management experience in an international environment
  • Demonstrated experience in all phases of development; experience working on global and complex clinical trials
  • Demonstrated experience with successful regulatory filings; comprehensive understanding of global regulatory requirements


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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