Vice President of Clinical and Regulatory

MD (or PhD) with 10+ years of clinical and regulatory experience to lead the development and execution of all clinical programs.

Company: Collegium Pharmaceutical, Inc.

(www.collegiumpharma.com)

Job Title: Vice President of Clinical and Regulatory

Location: Cumberland, Rhode Island

The Company:

Collegium Pharmaceutical, Inc. is a specialty pharmaceutical company focused on the development of proprietary, late stage pharmaceutical products. These products target market opportunities through formulation based product improvements protected by intellectual property (IP).  Collegium is focused on building a portfolio of pain products that incorporate its patent protected DETERx™ formulation platform that provides for extended release and tamper resistance. Visit the Company’s website at www.collegiumpharma.com

Responsibilities:

• Lead the development and execution of all clinical programs including Phase I-III studies. Participate in the selection and management all out-source partners
• Provide clinical and regulatory planning, management, and strategy for products in development. This involves developing the clinical and regulatory strategy, timelines and managing all filings and FDA interactions including but not limited to IND’s, NDA’s.
• Lead the development of all submissions to the FDA. Communicate and negotiate with the FDA as appropriate. Interact with company’s current panel of consultants and where applicable add consultants to assure appropriate topic specific expertise.
• Review and interpret FDA guidelines and feedback as it pertains to the company’s products
• Lead the development of the Company’s lead product through NDA submission and approval.

Requirements:

• MD (or PhD)
• 10+ years of clinical and regulatory experience working in pharmaceutical industry preferably specialty pharmaceuticals and or mid- to small company environments.
• Strong background in clinical drug development including, clinical trial management (site selection through data analysis), regulatory strategy development and key opinion leader relationships.
• Experience in clinical development of CNS products specifically products for the treatment of chronic pain
• Innovative and entrepreneurial, willing to challenge traditional thinking with well thought-out comprehensive plans.
• Substantial experience in dealing with the FDA including, verbal, written and face to face interactions.

• Excellent presentation and analytical skills

Compensation:

An attractive compensation package commensurate with qualifications and experience will be offered to the successful candidate.

Location:

TBD (Company headquarters in greater Boston Area)

Report to:

President