Bicara Therapeutics
Senior Clinical Trial Manager (Global)
Boston · Senior
Sponsorship not specified$10k-$20kDetected 34 days ago
BudgetingClinical TrialsClinical ResearchResearchLeadershipCommunicationCollaborationAdaptability
About the role
- Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation.
- For more information, please visit www.bicara.com http://www.bicara.com.
- We encourage people from all backgrounds to apply.
Responsibilities
- Execute Bicara's clinical operations strategy of high-touch, patient-centered clinical trials with a strong focus on adaptive and seamless designs to support registration.
- Support clinical operations team in ensuring all trial deliverables are met according to timelines, budget, operational procedures, and quality standards.
- Assigned responsibilities can include development of specific sections of related study documents (e.g., sections of the lab manual)
- Work closely with external collaboration partners with a focus on relationship management and efficiency
- Lead the proactive identification, assessment, and management of clinical study challenges and risks.
- Support the oversight of all study activities including site identification and selection, enrollment models, clinical supply planning, budget planning and trial execution.
- Work with CRO to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensure that performance expectations are met.
- Participate in the development and authorship of study documents including protocol, investigator brochure, informed consent, etc.
- Participate in Case Report Form design and user acceptance testing in partnership with Data Management as well as data monitoring over the course of the study.
- Assigned responsibilities can include development of specific sections of related study documents (e.g., sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
Requirements
- Bachelor's Degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Minimum of 5 years' clinical trial management experience in the pharmaceutical, biotech and/or CRO industry.
- Global clinical trial management in fast paced CRO outsourced environment required.
- Must be adaptable and enjoy working in a fast-paced environment.
- Effective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables.
- Bicara Therapeutics is seeking a Senior Clinical Trial Manager (Global) to oversee multiple regions and help lead the operational execution required to bring our science to patients.
- Demonstrated ability to manage global clinical trials, navigating regional regulatory requirements, cultural nuances, and varying site capabilities across multiple geographies
- Clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors.
- Experience and ability to manage global or regional teams in a virtual environment.
- Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.
- Willingness to travel up to 10-20% of the time.
- Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit www.bicara.com http://www.bicara.com.
Nice to have
- Phase 2/Phase 3 study experience strongly preferred
- Oncology study experience strongly preferred.
Compensation
- $10k-$20k
Benefits
- Contribute to and/or author clinical sections of regulatory documents including Investigators' Brochures, safety updates, and responses to Health Authority / Ethics Committee questions.
Visa & Work Authorization
- not limited to: Monitoring visit report review, periodic review of data quality, review of CRO/Vendor KPIs, performing Sponsor Oversight Visits, etc
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