Director/senior Director, Regulatory Affairs, Therapeutics

OPPORTUNITY Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.  This role will be responsible for coordinating all aspects of regulatory strategy, interactions, and filings. The Director/Sr. Director will oversee and partner with several external consultants in the short term.  In the longer term, they will be responsible for building out the regulatory function for the company.   This is a leadership position that will play a critical role in the successful development of the Mammoth therapeutic candidates.  The role will report into the SVP of Translational Science.

KEY RESPONSIBILITIES

• Lead, define and manage the strategic regulatory direction for Mammoth's pipeline
• Establish the regulatory pathway to IND filing in complex programs using a novel gene editing technology
• Collaborate with various regulatory consultants, clinical advisory board members, and board members to maintain regulatory knowledge of US and EU
• Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities
• Serve as a liaison between the company and regulatory agencies
• Maintain real time understanding of Mammoth's target patient population
• Develop and coordinate high quality submissions for global clinical trials

REQUIRED QUALIFICATIONS

• Bachelor’s degree in life sciences
• Minimum of 10+ years of experience in the biotechnology and/or biopharmaceutical industry (Master’s degree with 8+ years of experience or PhD with 6+ years of experience); Sr. Director: Minimum of 12+ years of experience in the biotechnology and/or biopharmaceutical industry (Master’s degree with 10+ years of experience or PhD with 8+ years of experience).
• Minimum of 7 years in a Regulatory capacity with experience in drug development
• Experience with US and clinical trial submissions through with CBER/OTAT or ex-US equivalent
• Proven track record with regulatory agencies
• Strong project management skills and drive for excellence
• Experience with gene therapy products regulatory requirements
• Proven success interacting efficiently with Preclinical Research, CMC, and Clinical
• Ability to be onsite a minimum of 2-3x/ per week from a reasonable commuting distance within the Bay Area

PREFERRED QUALIFICATIONS

• Advanced degree in life sciences
• Creative problem solver

BENEFITS

• Company-paid health/vision/dental benefits
• Unlimited vacation and generous sick time
• Company-sponsored meals and snacks
• Wellness, caregiver and ergonomics benefits
• 401(k) with company matching