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Clinical Development Lead - Neurology

Date: Aug 12, 2019

Location: Philadelphia, PA, US

Company: Spark Therapeutics

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.

Summary

The role of the Clinical Development Lead-Neurology is

  • To define global clinical strategy and provide medical support for all global neurology/CNS clinical research and development activities (e.g., clinical program/trial development—all phases of development, medical and safety assessments) and global regulatory interactions. S/he will collaborate to apply learnings from other gene therapy programs to CNS programs, as needed.
  • To assist the Medical Affairs team (when necessary), providing neurology/CNS 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

Responsibilities

  • 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 CNS/neurologic clinical programs
  • Participate in product development 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 the clinical programs
  • 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
  • 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 for CNS/neurology programs
  • Participate in development, review and/or presentation of clinical data in Training, Managed Care, or other presentations, as needed
  • Provide neurologic 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 medical/clinical 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.

Requirements

MD/DO degree required, neurology training and clinical practice preferred, board certification preferred

Generally has a minimum of 10 years pharmaceutical and/or clinical experience; global experience preferred

Prior pharmaceutical experience in neurology/CNS (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

Competencies

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

Self-motivated and detail-oriented with the ability to prioritize and handle multiple projects

Ability to plan and think strategically and critically

Ability to function as mentor and to develop junior staff

Ability to critically evaluate and analyze scientific data and literature


Nearest Major Market: Philadelphia

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