- 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
- 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
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Director/Senior Director, Regulatory Affairs, Therapeutics - Brisbane, United States - Mammoth Biosciences
Description
Mammoth BioSciences
OPPORTUNITYMammoth 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
REQUIRED QUALIFICATIONS
PREFERRED QUALIFICATIONS
BENEFITS
The listed base salary range is for Mammoth employees in the Bay Area. Actual base salary will be determined by geographic work location, relevant professional experience, applicable skills, and internal equity. The base salary range for those working remotely outside of the San Francisco Bay Area may differ and will be determined by industry market data for the role and specific region.
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.
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