Clinical Development Lead - Inherited Metabolic Diseases

Summary

The Clinical Development Leader is responsible for contributing to the creation of clinical strategies that will support Spark’s product development and commercialization objectives, and for the design and successful execution of clinical trials, specifically in the area of inherited metabolic diseases (eg, lysosomal storage diseases, etc). S/he will participate in the analysis and interpretation of clinical results for regulatory submissions and publications, and will provide medical/clinical support in strategic planning activities and will assist (as appropriate) in the evaluation of new business development opportunities.

Responsibilities

80%

• Participate in the design of clinical trials for the purpose of meeting specific objectives; able to anticipate and address future commercial and clinical development needs
• Support and motivate the clinical operations team to effectively and efficiently operationalize the clinical development strategy (i.e., 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
• Participate in the review, analysis and interpretation of the results of clinical programs in collaboration with relevant experts; develop 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

10%

• Provide clinical/medical expertise to global commercial and Medical Affairs teams, as needed. Participate in advisory boards, support global initiatives; attend and participate in scientific meetings as needed
• Serve as internal resource/reviewer and medical/clinical expert for Corporate Communications personnel and other functional areas, as needed

10%

• Able to critically evaluate new business opportunities and potential new product candidates from a clinical/safety perspective; participate in evaluations and due diligence activities, as appropriate
• Provide medical/clinical insight into competitive developments
• Other duties as assigned

Qualifications

• Advanced understanding of clinical medicine, clinical pharmacology, and associated disciplines (i.e., 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

Requirements

• MD/DO, or PhD in life sciences; significant experience in a therapeutic area of interest to Spark is valuable (i.e., immunology, CNS/neurology, ophthalmology, hematology,  inherited metabolic diseases, hepatology, gene therapy)

• Minimum of 10 years of global pharmaceutical/clinical research experience, including clinical operations experience

• 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