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Bicara Therapeutics is seeking an experienced and detail-oriented individual to fill the role of Clinical Data Manager. In this position, you will be responsible for overseeing data management activities for Bicara-sponsored clinical trials and ensuring that all clinical data is collected, entered, and managed accurately and efficiently.

As a Clinical Data Manager, you will be responsible for developing and implementing data management processes and procedures, and for training and overseeing data management staff, as required. You will be working closely with other departments, including clinical operations, statistics, and biostatistics, to ensure that data is collected and managed according to industry standards and regulations.

To be successful in this role, you should have a strong background in clinical data management, as well as experience in project management and leading teams. You should also be detail-oriented and able to manage multiple tasks and priorities effectively.

Key Responsibilities

• Oversee clinical data management activities and ensure that all data is collected, entered, and managed accurately and efficiently
• Develop and implement data management processes and procedures
• Train and oversee vendor operations including DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans
• Independently perform and guide study team members (e.g., Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics scientists, Medical Writers, Regulatory representatives, etc.) through the data cleaning and database lock process in an efficient and timely manner
• Work closely with other departments to ensure that data is collected and managed according to industry standards and regulations
• Manage multiple tasks and priorities effectively

Required Qualifications

• Bachelor’s degree in a related field
• At least 5 years of experience in clinical data management
• Experience in project management and leading teams
• Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process
• Strong attention to detail and ability to manage multiple tasks and priorities
• Knowledge of industry standards and regulations for clinical data management

Company Overview

At Bicara Therapeutics, Inc., a clinical-stage biopharmaceutical company, we are united around a shared purpose: To develop first-in-class bifunctional antibodies combining the precision of targeted therapy and the power of immunotherapy. Our approach enables us to activate a powerful immune response precisely at the tumor site, minimizing the potential for systemic side effects.

Just as we bring together two modalities in our bifunctional therapies, our team also bridges two continents with teams in Cambridge, Mass. and in Bangalore, India. Together we are working towards a shared vision to provide first-in-class, high impact therapies to cancer patients.

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.

To apply, please email your resume/CV to careers@bicara.com. In the subject line include your name and the job title.

The Medical Director of Translational Medicine is a key member of Bicara’s clinical leadership team and will report to the Chief Medical Officer to help shape and execute Bicara’s strategy to build a biomarker strategy in supporting the development of our pipeline. Responsibilities will also include designing and monitoring the clinical trial with our novel bifunctional antibody scheduled to file an IND at end of 2021. This role will identify and manage CROs and academic institutions to carry out state-of-the art biomarker studies for researching target engagement/PD effects and confirming MOA of Bicara’s clinical assets. He/She will have proven success in leading the design and generation of clinical trials and clinic-ready biomarker assays to support clinical programs as well as help build strong translational data packages supporting INDs.

Key Responsibilities

• Collaborate closely with clinical team to implement strategies for translational and clinical biomarker assays using patient samples to define PK/PD/efficacy relationships for advanced assets in preclinical and clinical settings
• Design and clinically monitor the clinical trial as part of the IND
• Oversee external vendors, internal teams, and collaborators to develop, qualify, transfer, and validate clinical assays, as well as interpret/analyze biomarker data to support development programs across Bicara’s clinical pipeline
• Actively participate in troubleshooting and improvement in the quality of the experiments, while ensuring documentation practices are compliant with regulatory expectations on data integrity
• Ensure delivery of project milestones and timely communication of goals and deliverables to senior management and governance committees
• Author and review technical reports and summary documents for regulatory filings as well as relevant sections of clinical documents, scientific presentations, and publications
• Work closely with discovery and clinical teams to develop translational hypothesis, design and implement translational studies to generate data supporting INDs as well as help define biomarker strategies for early preclinical programs

Required Qualifications

• D. or MD Required, PhD/MD preferred along with 5+ years of industry experience
• Strong work experience in translational research, preferably in human immunology/immuno-oncology, using multiple orthogonal techniques and human tissues such as blood and tumor tissue samples
• Technical/analytical experience of working with flow cytometer, immunohistochemistry, and -omics based approaches, e.g., single-cell RNA seq analysis, Nanostring, 10X Genomics etc
• Ability to collaborate seamlessly with CROs and academic collaborators in a fast-paced, dynamic team-oriented environment
• Knowledge of regulatory expectations and industry standards for clinical biomarker assays
• Outstanding organizational skills with the ability to prioritize and deliver against timelines and budgets for multiple projects simultaneously
• Strong interpersonal skills to develop important relationships with team members, cross-functional teams, and all stakeholders to drive problem solving and transparent decisions

Company Overview

At Bicara Therapeutics, Inc., a clinical-stage biopharmaceutical company, we are united around a shared purpose: To develop first-in-class bifunctional antibodies combining the precision of targeted therapy and the power of immunotherapy. Our approach enables us to activate a powerful immune response precisely at the tumor site, minimizing the potential for systemic side effects.

Just as we bring together two modalities in our bifunctional therapies, our team also bridges two continents with teams in Cambridge, Mass. and in Bangalore, India. Together we are working towards a shared vision to provide first-in-class, high impact therapies to cancer patients.

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.

To apply, please email your resume/CV to careers@bicara.com. In the subject line include your name and the job title.