(Senior) Director - Global Clinical Operations - Bicara Therapeutics : Job Details

Company Overview

Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics engineered to bring together the precision of targeted therapy and the power of tumor modulators. The company s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, potentially offering long-lasting efficacy. Bicara s lead asset, BCA101, a first-in-class EGFR / TGF- -trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b study. Bicara s experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy. More information is available at www.bicara.com.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Role Responsibilities

Lead clinical operations globally to support the scope of our clinical development programs including development of both office and field-based clinical operations staff.

Support the clinical operations strategy and business model to support high-touch, patient-centered clinical trials with a strong focus on adaptive and seamless designs with early generation of data to support registration

Work closely with external collaboration partners with a focus on relationship management and efficiency

Contributes to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with project teams and stakeholders

Partner closely with leadership to design, plan and execute innovative clinical trial designs leveraging the needs and opportunities of biologics development.

Cultivates relationships with external partners such as clinical investigators, clinicians, and scientists in support of innovation and business development

Assist with the due diligence process as it pertains to future pipeline opportunities

Develop, propose and implement clinical trial strategy for responsible pipeline programs and indication.

Lead the proactive identification, assessment, and management of clinical study-related issues and risks.

Provide clinical operations support and management for all study activities including site identification and selection, enrollment models, clinical supply planning, CRO selection and negotiations, budget planning and trial execution.

Monitor study progress including: CRO and third-party vendors, ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs, as applicable.

Work with CRO to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensures that performance expectations are met.

Collaborate with internal medical director in development and authorship of study protocol

Collaborate with scientific teams in project planning for future programs

Participate in Case Report Form design, user acceptance testing in partnership with Data Management.

Oversee study management and/or clinical development teams (CROs) to facilitate clinical development goals and achievement of study quality metrics

Execute CRO/Third Party Oversight Activities including but not limited to: Monitoring visit report review, periodic review of data quality, review of CRO/Vendor KPIs, performing Sponsor Oversight Visits, etc.

Contribute to and/or author clinical sections of regulatory documents including Investigators Brochures, safety updates, and responses to Health Authority / Ethics Committee questions

Contribute to and/or author publications with cross functional team members

Champion and support the development and implementation of SOPs, Quality Management Systems and GxP processes