Regulatory Affairs Director
3 weeks ago
Mammoth Biosciences is seeking a highly experienced Director/Senior Director, Regulatory Affairs, Therapeutics to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
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
- 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
- Advanced degree in life sciences
- Creative problem solver
- 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
Mammoth Biosciences is a biotechnology company focused on leveraging its proprietary ultracompact CRISPR systems to develop long-term curative therapies, as well as other applications such as decentralized precision diagnostics. Founded by CRISPR pioneer and Nobel laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington, the company's ultracompact proteins are designed to enable in vivo gene editing in difficult-to-reach tissues utilizing both nuclease applications and new editing modalities beyond double-stranded breaks, including base editing, gene writing, and epigenetic editing. The company is building out its pipeline of potential in vivo gene editing therapeutics and capabilities and has partnerships with leading pharmaceutical and biotechnology companies to broaden the reach of its innovative and proprietary technology. Mammoth's deep science and industry experience, along with a robust and differentiated intellectual property portfolio, have enabled the company to further its mission to transform the lives of patients and deliver on the full promise of CRISPR technologies.
Mammoth Biosciences is an equal opportunity employer and welcomes applications from diverse candidates. It is our policy and intent to provide equal opportunity to all persons without regard to race, color, religion, political affiliation, sex/gender (including gender expression/identity, pregnancy, childbirth, and related medical conditions), marital status, registered domestic partner status, sexual orientation, age, ancestry, national origin, veteran status, disability, medical condition, genetic characteristics, and/or any other basis protected by law.
Mammoth Biosciences requires that all employees be vaccinated against COVID-19 as a condition of at-will employment, with exceptions for medical or religious reasons in compliance with local, state, and federal law.
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