Demo

(Associate) Director/Senior Director, Regulatory Affairs, Therapeutics

Mammoth Biosciences
Brisbane, CA Full Time
POSTED ON 2/17/2025
AVAILABLE BEFORE 5/14/2025

OPPORTUNITY

Mammoth is hiring a(n) (Associate) 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 (Associate) 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 - $260,000

    Actual base salary will be determined by relevant professional experience, applicable skills, and internal equity.

    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.

    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 as a condition of at-will employment, with exceptions for medical or religious reasons in compliance with local, state, and federal law.

    Salary : $205,000 - $260,000

    If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
    Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

    What is the career path for a (Associate) Director/Senior Director, Regulatory Affairs, Therapeutics?

    Sign up to receive alerts about other jobs on the (Associate) Director/Senior Director, Regulatory Affairs, Therapeutics career path by checking the boxes next to the positions that interest you.
    Income Estimation: 
    $219,423 - $248,819
    Income Estimation: 
    $280,031 - $485,657
    Income Estimation: 
    $78,084 - $104,270
    Income Estimation: 
    $95,800 - $126,196
    Income Estimation: 
    $97,803 - $128,184
    Income Estimation: 
    $95,508 - $129,349
    Income Estimation: 
    $212,419 - $307,933
    Income Estimation: 
    $308,977 - $498,049
    Income Estimation: 
    $263,669 - $375,263
    Income Estimation: 
    $176,359 - $246,541
    Income Estimation: 
    $242,066 - $328,520
    Income Estimation: 
    $212,419 - $307,933
    Income Estimation: 
    $190,069 - $273,730
    Income Estimation: 
    $140,918 - $196,956
    Income Estimation: 
    $188,947 - $264,846
    Income Estimation: 
    $176,359 - $246,541
    Income Estimation: 
    $158,728 - $233,218
    View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

    Job openings at Mammoth Biosciences

    Mammoth Biosciences
    Hired Organization Address Brisbane, CA Full Time
    Join Mammoth Biosciences as we pioneer the development of long-term curative therapies using CRISPR technology. Our team...
    Mammoth Biosciences
    Hired Organization Address Brisbane, CA Full Time
    Mammoth Biosciences is a biotechnology company dedicated to transforming the lives of patients through innovative CRISPR...

    Not the job you're looking for? Here are some other (Associate) Director/Senior Director, Regulatory Affairs, Therapeutics jobs in the Brisbane, CA area that may be a better fit.

    Senior Director, Regulatory Affairs

    Marea Therapeutics, San Francisco, CA

    AI Assistant is available now!

    Feel free to start your new journey!