Selecta Biosciences, Inc. is a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance (ImmTOR) platform.
The Manager, Clinical Operations is a pivotal member of Selecta’s clinical team. Reporting to the Sr. Director, Clinical Operations, the position will be responsible for the management of all daily clinical operations activities for one or more of the Company’s Phase I – III clinical trials. The responsibility will encompass managing the overall clinical trials including the identification of study-level operational risks and assisting in the development of contingency plans. This position will work closely with representatives for assigned functional groups, assist with the management of study conduct, attend cross-functional program meetings, coordinate with outside parties (e.g., CRO’s), and provide Clinical Operations support for interactions with regulatory agencies and ensure alignment between study plans and overall corporate objectives.
- Oversee performance of CROs and third-party vendors to ensure compliance with study protocol(s) and in accordance with scopes of work for the full duration of the study; identify areas of concern, opportunities for improvement, and escalate to Sr. Director, Clinical Operations or CRO responsible representative as appropriate
- Broadly contribute to clinical trial design
- Develop and implement project execution plans to achieve short-term and long-term goals
- Proactively identify potential risks and work with teams to develop risk mitigation plans
- Complete critical path analyses including the evaluation of potential means to accelerate programs and to mitigate identified risks. Manage the clinical operations to recommend revised strategies as appropriate.
- Develop, build, and maintain productive interactions with CRO(s)
- Generate clinical trial status updates and communications
- Assist with the management of an integrated timeline and corresponding budget for the clinical trial(s). Work with the team to maintain the timeline as current and manage budgetary spends.
- Perform clinical data review of data listings and summary tables
- Ensure studies are carried out according to the study protocol, SOPs, ICH/GCP regulations, study-specific plans, manuals and procedures
- Ensure on-site QC visits are performed at select clinical trial sites to ensure oversight of the clinical trial (e.g. evaluate monitoring performance and rapport with site, site performance, etc.)
- Determine the need for and if applicable, assist with the development and implementation of study specific Audit Plan
- Assist with investigational product (IP) accountability and reconciliation process as appropriate
- Contribute to preparation of clinical protocols, and study-related documents
- Assist in identification and perform initial review of CRO and other third-party study vendor invoices to ensure that work is performed in accordance with scope of work
- Assist with planning and preparation for Investigator Meetings in collaboration with CRO team, and assist with third party vendor training on study protocol(s) and expectations/processes
- Other duties as assigned
- Bachelor’s degree in a scientific discipline
- 5+ years of experience in the biotech or pharmaceutical industry
- 3+ years of experience managing clinical trials in various stages of drug development
- Strong knowledge of all aspects of the clinical trial process
- General understanding of GCPs with formal training preferred
- Strong interpersonal, organizational, planning, and communication skills
- Ability to work independently with flexibility to manage workflow in a multi-tasking environment
Responsibilities include a work schedule that can require working outside of “normal” work hours to meet global business demands. Position may be work from home/remote. Prefer candidates to be located in Eastern or Central time zones.
About Selecta Biosciences, Inc.
Selecta Biosciences Inc. (NASDAQ: SELB) is leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses.
With a proven ability to induce tolerance to highly immunogenic proteins, ImmTOR has the potential to amplify the efficacy of biologic therapies, including redosing of life-saving gene therapies, as well as restore the body’s natural self-tolerance in autoimmune diseases. The company’s first program aimed at addressing immunogenicity to AAV gene therapies is expected to enter clinical trials in early 2021 in partnership with AskBio for the treatment of methylmalonic acidemia (MMA), a rare metabolic disorder. A wholly-owned program focused on addressing IgA nephropathy driven by ImmTOR and a therapeutic enzyme is also in development among additional product candidates. Selecta recently licensed its Phase 3 clinical product candidate, SEL-212, in chronic refractory gout to Sobi. For more information, please visit www.selectabio.com.
Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).
Recruitment & Staffing Agencies
Selecta Biosciences does not accept agency resumes unless contacted directly by internal human resources department. Selecta Biosciences is not responsible for any fees related to unsolicited resumes.