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Director/Senior Director, Regulatory Affairs, Therapeutics

Mammoth BiosciencesMammoth Brisbane, California, United StatesOnsite
OPPORTUNITY
Mammoth is hiring aDirector/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

Base Salary Range: $ 205,000 - $260,000Actual base salary will be determined by relevant professional experience, applicable skills, and internal equity. COMPANYMammoth 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.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.

This policy covers all facets of employment including, but not limited to: recruitment, selection, placement, promotions, transfers, demotions, terminations, training, and compensation.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. Apply for this job

Life at Mammoth Biosciences

Mammoth Biosciences is harnessing the diversity of nature to power the next-generation of CRISPR products. Through the discovery and development of novel CRISPR systems, the company is enabling the full potential of its platform to read and write the code of life. Mammoth aims to democratize disease detection with an easy and affordable point-of-care test that allows real-time and simultaneous detection of multiple conditions. By leveraging its internal research and development and exclusive licensing to Cas12, Cas13 and Cas14, Mammoth can provide enhanced diagnostics and genome editing for life science research, healthcare, agriculture, biodefense and more. Based in San Francisco, Mammoth Biosciences is co-founded by CRISPR pioneer Jennifer Doudna and principal founders Trevor Martin, Janice Chen, and Lucas Harrington. The firm is backed by top institutional investors including Mayfield, NFX, and 8VC, Decheng and leading individual investors including Brook Byers, Tim Cook, and Jeff Huber.
Thrive Here & What We Value- Unlimited vacation and generous sick time- Company-sponsored meals and snacks- Wellness, caregiver, and ergonomics benefits- 401(k) with company matching- Equal opportunity policy
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