The Assistant Director, Clinical Operations will be accountable for strategic and operational management and successful execution of late phase clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and regulatory requirements. They are well versed in knowledge of operational methodologies, clinical research, ICH/GCP Guidelines, program management, communication to upper management and delegation to/oversight of Clinical Trial Managers. They are responsible for the development of the clinical timelines and are the co-author of the individual study timelines/deliverables/milestones.

Key Responsibilities

• Lead certain aspects of clinical operations to support the scope of our clinical development programs.
• 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.
• 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 ensure 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 and 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.
• Support the development and implementation of SOPs, Quality Management Systems and GxP processes.

Qualifications

• years of experience in clinical operations and a BS/BA or higher degree in a relevant scientific discipline.
• 3 oncology experience required.
• clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors.
• of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details.
• and ability to manage global or regional teams in a virtual environment.
• knowledge of human subject's research ethics and clinical trial practices and policies to include ICH, GCP, FDA regulations, IRB policies, complex visit structures, budgets and contracts.
• in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies.
• decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.
• be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
• leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables.
• to travel up to 10-20% of the time.

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-β-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.