Director, Clinical Operations

Company: Mammoth Biosciences
Location: Brisbane
Posted on: June 1, 2025

Job Description:

Mammoth BioSciencesOPPORTUNITYMammoth Biosciences is seeking an experienced Director, Clinical Operations to join our team. This role will ensure that clinical stage programs achieve program objectives within established timelines, budget, and quality standards. The selected candidate will be involved in contributing to the development of clinical program strategy, building a clinical operations team, and ensuring superior execution and transparency within the department. They will have primary responsibility for clinical trial program oversight within assigned indications including day to day responsibility for trial management. The successful hire will oversee implementation of FIH clinical studies in a high quality, timely and cost-effective manner. The Director, Clinical Operations will ensure that all studies within the program are executed in accordance with US, EU and other governmental regulations as applicable, as well as with appropriate ICH/GCP guidance. This individual will manage cross functional relationships with internal and external stakeholders and will be extremely hands on fostering relationship development with CROs and KOLs. This is a high visibility position with great impact potential.
KEY RESPONSIBILITIESActively participate in strategic planning activities for assigned programs including budgeting, resource management and vendor identification/managementEnsure adequate resources for clinical operations including overseeing operational plans, tactical execution of trials, protocol preparation, report writing, regulatory submissions, etc.Develop, write, implement and maintain operational procedures and processes within the programsDirect clinical program implementation to meet program timelines and budgetLead clinical projects as required including developing the clinical research strategy, supporting investigator and site selection, identifying, evaluating, selecting CROs and managing CRO performance.Oversee CROs and external vendors on a day-to-day basis including issue tracking/resolution, timeline/budget managementDomestic and international travel, dependent on program needFoster a collaborative culture and serve as a leadership role modelREQUIRED QUALIFICATIONSBachelor's or Master's degree in health sciences or related fieldMinimum 10 years of clinical trial management experience (8 years with Master's)Experience with global clinical trialsPrior experience selecting and managing CROsExpertise in clinical development process, global regulatory requirements, and CRO/vendor management Ability to foster effective relationships with vendors, investigators and colleaguesAbility to contribute technical expertise to the various aspects of the clinical trial processKnowledge of industry standards as applied to ICH guidelines, GCPs and the CFRExcellent communication, writing and presentation skillsAbility to assess complex issues and propose viable solutionsAbility to travel domestically and internationally as neededPREFERRED QUALIFICATIONSExperience with gene editing modalities is highly preferred Experience supporting early stage projects Familiarity with QbD principles and lifecycle management of analytical methodsDirect experience with managing CDMOs and CROsBENEFITSCompany-paid health/vision/dental benefitsUnlimited vacation and generous sick timeCompany-sponsored meals and snacksWellness, caregiver and ergonomics benefits401(k) with company matchingBase Salary Range: $192,000 - $240,000 per yearActual 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 as a condition of at-will employment, with exceptions for medical or religious reasons in compliance with local, state, and federal law. PIa6e8a411db57-25660-37646240

Keywords: Mammoth Biosciences, Sacramento , Director, Clinical Operations, Executive , Brisbane, California