OPPORTUNITY
Mammoth 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 RESPONSIBILITIES
- Actively participate in strategic planning activities for assigned programs including budgeting, resource management and vendor identification/management
- Ensure 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 programs
- Direct clinical program implementation to meet program timelines and budget
- Lead 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 management
- Domestic and international travel, dependent on program need
- Foster a collaborative culture and serve as a leadership role model
REQUIRED QUALIFICATIONS
- MS or advanced degree in health sciences or related field
- 8+ years of clinical trial management experience
- Experience with global clinical trials
- Prior experience selecting and managing CROs
- Expertise in clinical development process, global regulatory requirements, and CRO/vendor management
- Ability to foster effective relationships with vendors, investigators and colleagues
- Ability to contribute technical expertise to the various aspects of the clinical trial process
- Knowledge of industry standards as applied to ICH guidelines, GCPs and the CFR
- Excellent communication, writing and presentation skills
- Ability to assess complex issues and propose viable solutions
- Ability to travel domestically and internationally as needed
PREFERRED QUALIFICATIONS
- Experience with gene editing modalities is highly preferred
- Experience supporting early stage projects
- Familiarity with QbD principles and lifecycle management of analytical methods
- Direct experience with managing CDMOs and CROs
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: $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. Apply for this job
