Clinical CNS Lead - Philadelphia, PA | Biospace
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Clinical CNS Lead

Spark Therapeutics

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Location:
Philadelphia, PA
Posted Date:
11/15/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:
Clinical Research, Genetics, MD, Medical Director, Neurology,

Job Description

PRIMARY DUTIES:
To define global clinical strategy and provide medical support for all global neurology/CNS clinical research and development activities (eg, 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 neurology/CNS 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 neurologic clinical programs
Participate in product development teams and subteams 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
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
Participate in development, review and/or presentation of clinical data in Training, Managed Care, or other presentations, as needed
Provide neurologic 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 required

Requirements

EDUCATION and EXPERIENCE REQUIREMENTS:
MD/DO degree required, neurology training and clinical practice preferred, board certification preferred
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
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
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)
COMPLEXITY and PROBLEM SOLVING:
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
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.
TRAVEL:
25%