Director, Clinical Operations
Cambridge, MA
Full Time
Manager/Supervisor
Director of Clinical Operations
Repertoire Immune Medicines is a biotechnology company working to unlock and direct the remarkable power of the human immune system to treat cancer and autoimmune disease. The company was founded on the belief that understanding the repertoire of T cell receptor (TCR)-antigen immune synapses that maintain health and drive disease represents one of the greatest opportunities for innovation in medical science. Repertoire scientists created and developed the DECODETM platform, which allows in-depth characterization of TCR-antigen pairs, and the ability to deploy this information in the form of novel targeted immune medicines to fundamentally reprogram the immune system to kill tumors or induce immune homeostasis.
From its sites in Cambridge, Massachusetts and Zurich, Switzerland, Repertoire’s team is advancing a pipeline of DECODE-enabled immune medicines. For cancer, we are developing a pipeline of TCR bispecifics molecules for treatment of multiple cancer types. In addition, we are developing a pipeline of mRNA tolerizing vaccines for treatment of autoimmune diseases.
Repertoire was founded by Flagship Pioneering and is supported by a strong investor base. In addition, the company recently entered a strategic partnership with Bristol Myers Squibb to develop tolerizing vaccines for up to three autoimmune diseases.
Role Overview
Reporting to the Chief Medical Officer (CMO), the Director of Clinical Operations will be responsible for the management, oversight, and hands-on execution of oncology clinical trial programs ensuring they are completed according to timelines, budgets, regulatory, and good clinical practices (GCP) quality standards. The selected candidate will have regular interaction with senior management and will be expected to communicate with and foster effective relationships with internal and external stakeholders.
Key Responsibilities
Recruitment & Staffing Agencies: Repertoire Immune Medicines (“Repertoire”) does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Repertoire or its employees is strictly prohibited unless contacted directly by Repertoire’s internal Human Resources team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Repertoire, and Repertoire will not owe any referral or other fees with respect thereto.
Repertoire Immune Medicines is a biotechnology company working to unlock and direct the remarkable power of the human immune system to treat cancer and autoimmune disease. The company was founded on the belief that understanding the repertoire of T cell receptor (TCR)-antigen immune synapses that maintain health and drive disease represents one of the greatest opportunities for innovation in medical science. Repertoire scientists created and developed the DECODETM platform, which allows in-depth characterization of TCR-antigen pairs, and the ability to deploy this information in the form of novel targeted immune medicines to fundamentally reprogram the immune system to kill tumors or induce immune homeostasis.
From its sites in Cambridge, Massachusetts and Zurich, Switzerland, Repertoire’s team is advancing a pipeline of DECODE-enabled immune medicines. For cancer, we are developing a pipeline of TCR bispecifics molecules for treatment of multiple cancer types. In addition, we are developing a pipeline of mRNA tolerizing vaccines for treatment of autoimmune diseases.
Repertoire was founded by Flagship Pioneering and is supported by a strong investor base. In addition, the company recently entered a strategic partnership with Bristol Myers Squibb to develop tolerizing vaccines for up to three autoimmune diseases.
Role Overview
Reporting to the Chief Medical Officer (CMO), the Director of Clinical Operations will be responsible for the management, oversight, and hands-on execution of oncology clinical trial programs ensuring they are completed according to timelines, budgets, regulatory, and good clinical practices (GCP) quality standards. The selected candidate will have regular interaction with senior management and will be expected to communicate with and foster effective relationships with internal and external stakeholders.
Key Responsibilities
- Manage and oversee the day-to-day clinical operations of the company's research studies and trials, including support of the development of the trial protocol and other study documents.
- Work closely with the CMO and the rest of the R&D Team to accumulate scientific and medical knowledge necessary to support clinical development plans, study designs, and protocols.
- Develop and implement operational strategies for clinical studies, including timelines, budgets, and resource allocation.
- Oversee and assist with the development of the clinical components of regulatory submissions.
- Assist in authoring of clinical trial protocols, investigator's brochures (IBs) informed consent forms (ICFs), clinical study reports (CSRs), and other clinical documents, as necessary.
- Lead protocol implementation with vendors and sites, and ensure operational feasibility of the clinical trial.
- Support the selection and management of Clinical Research Organizations (CROS), investigators, and clinical trial sites.
- Oversee data collection and management, including monitoring and reporting of adverse events.
- Collaborate and maintain strong relationships with CROs, vendors, and sites to ensure study deliverables are met and issues/risks are proactively identified and mitigated.
- Support the clinical operations infrastructure build to maintain inspection readiness.
- Ensure compliance with federal regulations, industry standards, and Good Clinical Practice guidelines.
- Lead cross-functional teams to effectively manage clinical trial timelines and deliverables.
- BA/BS/MS in a scientific degree with over 10 years in relevant clinical operations.
- Minimum of 5 years of early (Phase 1-2) oncology drug development experience including experience supporting IND submission activities. Desired experience in protein therapeutics.
- Multiple years of experience leading high-complexity programs and/or cross-functional initiatives in clinical operations, including short- and long-range strategic planning, governance and oversight.
- Extensive experience in the delivery of oncology clinical trial programs including understanding of oncology endpoints and approaches to ensure endpoint integrity.
- Demonstrated excellence in complex project management and effectively managing multiple projects, budget planning and priorities.
- In-depth understanding of industry standards and applicable guidelines.
- Proficient in regulatory submissions and audits.
- Deep knowledge of GCP, GLP, and GMP standards.
- Experience in developing Clinical Operations SOPs and metrics.
- Excellent leadership skills and ability to lead, direct, and support cross-functional teams.
- Strong collaboration, communication and organizational and problem-solving skills required.
Repertoire is committed towards social responsibility and developing an inclusive culture. Much as the power of the immune system lies in the diversity of T and B cells, our work requires the creativity and ingenuity of a diverse workforce. We believe in actively pursuing equity in all facets of the work experience at Repertoire. We will continue to educate ourselves about the inequities and barriers present in our society and take action as a company where we can make a difference.
Repertoire is proud to be an Equal Opportunity Employer.
Repertoire is proud to be an Equal Opportunity Employer.
Recruitment & Staffing Agencies: Repertoire Immune Medicines (“Repertoire”) does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Repertoire or its employees is strictly prohibited unless contacted directly by Repertoire’s internal Human Resources team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Repertoire, and Repertoire will not owe any referral or other fees with respect thereto.
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