Join Us: Careers & Culture

At Bicara, we bring together the agility and passion of a startup with the confidence and focus of an established biopharma. Our team is dynamic, diverse and driven — and we have proven that we can deliver, with a first IND and lead program already in the clinic.

Together, we are determined to bring high-impact, first-in-class medicines to cancer patients.

Interested in joining the Bicara team?

  • Senior Accountant / Accounting Manager
  • Director, Information Technology
  • Clinical Trial Manager (Boston)
  • Senior Clinical Trial Manager (United Kingdom – remote)
  • Associate Director, Clinical Operations & Vendor Management
  • Senior Director, Global Clinical Operations
  • Senior Medical Director, Clinical Development

POSITION SUMMARY

Bicara Therapeutics is seeking a Senior Accountant / Accounting Manager to join our Finance team. This individual will be a key member of the team and will also provide support and assist in many aspects of financial accounting and reporting. This is a new position that will interact with all levels of management. This is a hands-on position and the ability to multitask and work with others is essential, as well as the ability to work efficiently and effectively in a remote capacity, as needed.

KEY RESPONSIBILITIES

  • Prepare annual and quarterly financial statements
  • Month-end close
  • Technical accounting
  • Review and approve employee expense reports and maintain Expensify database
  • Prepare Review mapping of invoices to the correct account
  • Setup payment runs
  • Prepare reconciliations for certain accounting areas such as research and development, manufacturing, clinical accrual investments and other accounting transactions as needed
  • Assist with external audit and tax consultants’ requests
  • Assist with investors’ financial request
  • Assist in the coordination of SOX compliance documentation and testing
  • Participate in special projects and ad hoc reporting as necessary

REQUIRED SKILLS

  • SEC reporting
  • Internal controls compliance
  • Ability to search adoption of new accounting guidance
  • Proven attention to detail and excellent quantitative and analytical skills
  • Provide professional customer service internally and externally
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload
  • A flexible attitude with respect to work assignments and new learning
  • Excellent interpersonal, verbal, and written communication skills; value the importance of teamwork
  • Open to change and willing to learn new accounting areas.

REQUIRED QUALIFICATIONS

  • BS or BA degree in Accounting
  • CPA required
  • 3+ years of experience; pharmaceutical industry experience a plus
  • Advanced Excel skills; very good level of proficiency in Microsoft Office
  • Knowledge of Prendio, Bill.com, NetSuite or another ERP a plus

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.

To apply, please email your resume/CV to [email protected]. In the subject line include your name and the job title.

POSITION SUMMARY

In this newly created leadership role, the Director of Information Technology (IT) will be a key member of the organization reporting to the President & Chief Operating Officer. They will create and manage the strategic direction for the Company’s IT operations, ensuring efficient and effective technology services throughout the organization and driving next-level maturity to enable ongoing growth and future scaling of our IT operations. To support these efforts they will partner closely with all business functional units and external managed services provider(s).

KEY RESPONSIBILITIES

  • Develop and maintain the IT Operation organization’s strategic road map, ensuring IT
    capabilities, including data management and security, consistently support the organization’s goals and priorities
  • Partner with business organizational teams to play a strategic role in the exploration and selection, implementation, and ongoing management of the company’s software, hardware, and technology support services.
  • Responsible for overall IT process development, documentation and oversight (e.g., user, vendor and company onboarding, offboarding, end user support and emergency management).
  • Develop and maintain a well-structured lifecycle management strategy of all hardware, and software assets, including effective user onboarding and offboarding.
  • Provide oversight for developing, maintaining, and publishing technology standards, procedures, and guidelines.
  • Oversee IT systems, policies, and processes aligned with SOX compliance including implementation and monitoring of IT general controls, segregation of duties and documentation of controls and testing.
  • Own the planning, coordination, implementation, and change management related to cross-enterprise IT projects.
  • Partner with the Office Manager to ensure full support for facility changes and projects.
  • Create and manage the Disaster Recovery Program and IT Business Continuity plans.
  • Establish and manage strong vendor relationships and oversee negotiation and administration of vendors, consultants, and service agreements.
  • Lead the analysis, enhancement, and tailoring of current practices and existing systems to increase operating efficiencies and reduce costs
  • Establish and maintain IT related budgets to effectively meet company financial objectives

SKILLS, QUALIFICATIONS AND EXPERIENCE

  • Bachelor’s degree in Computer Science, Information Technology, Business Administration, or another related field.
  • A minimum of 10 years’ experience in the IT field; experience in biotech/pharma required; experience in GxP environments a plus.
  • Possess solid knowledge in emerging technologies, and the ability to apply these in the service of the company’s key business goals.
  • Demonstrated ability to build and lead the IT Operations and Service Desk functions.
  • Demonstrated ability to design and implement comprehensive approaches to cyber security and risk management.
  • Builder of strong technology vendor partnerships, and able to manage multiple vendor relationships to ensure the best performance and financial return.
  • Broad knowledge of a range of vendor technology solutions; able to select and integrate the most appropriate technologies to support the business.
  • Strong leadership, communication, collaboration, negotiation, problem-solving, decision-making, and influencing skills with the ability to engage with stakeholders at all levels; lead and support projects and change initiatives of various sizes and complexities enterprise wide.
  • Strong knowledge of IT financial, spend management, resource allocation management, change management, communication management, business process optimization, and continuous improvement methodologies and techniques.
  • Strategic thinker with a focus on problem solving, driving innovation, and continuous improvement.
  • Strong knowledge of project management methodologies, tools, and techniques; Project Management Professional (PMP) certification or equivalent preferred.

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.

To apply, please email your resume/CV to [email protected]. In the subject line include your name and the job title.

ROLE OVERVIEW

The Clinical Trial Manager works within the clinical trial team to provide regional trial oversight and ensures deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Director, Clinical Operations. This role may work collaboratively on one trial or across several trials to support clinical operations activities.

KEY RESPONSIBILITIES

Clinical Operations

  • Support the 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); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
  • 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.
  • Monitor oversight of 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.
  • 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.
  • 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.

QUALIFICATIONS

  • Bachelor’s Degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
  • Minimum of 2-5 years clinical trial management experience in the pharmaceutical, biotech and/or CRO industry.
  • Experience in Oncology Studies and/or Phase 3 trials preferred.
  • Requires clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors.
  • Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details.
  • Experience and ability to manage global or regional teams in a virtual environment.
  • Experience with Phase 2 to Phase 3 studies preferred.
  • Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.
  • 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.
  • Willingness 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.

To apply, please email your resume/CV to [email protected]. In the subject line include your name and the job title.

 

ROLE OVERVIEW

The Clinical Trial Manager works within the clinical trial team to provide regional trial oversight and ensures deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Director, Clinical Operations. This role may work collaboratively on one trial or across several trials to support clinical operations activities.

KEY RESPONSIBILITIES

Clinical Operations

  • Support the 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); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
  • 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.
  • Monitor oversight of 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.
  • 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.
  • 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.

QUALIFICATIONS

  • Bachelor’s Degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
  • Minimum of 2-5 years clinical trial management experience in the pharmaceutical, biotech and/or CRO industry.
  • Experience in Oncology Studies and/or Phase 3 trials preferred.
  • Requires clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors.
  • Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details.
  • Experience and ability to manage global or regional teams in a virtual environment.
  • Experience with Phase 2 to Phase 3 studies preferred.
  • Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.
  • 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.
  • Willingness 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.

To apply, please email your resume/CV to [email protected]. In the subject line include your name and the job title.

 

ROLE OVERVIEW

The Associate 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

  • 10+ years of experience in clinical operations and a BS/BA or higher degree in a relevant scientific discipline.
  • Phase 3 oncology experience required.
  • Requires clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors.
  • Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details.
  • Experience and ability to manage global or regional teams in a virtual environment.
  • Advanced 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.
  • Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies.
  • Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.
  • Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
  • Effective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables.
  • Willingness 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.

To apply, please email your resume/CV to [email protected]. In the subject line include your name and the job title.

 

KEY RESPONSIBILITIES

  • Lead clinical operations 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

QUALIFICATIONS

  • 10+ years of experience in clinical operations and a BS/BA or higher degree in a relevant scientific discipline.
  • Phase 3 oncology experience required.• Requires clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors.
  • Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details.
  • Experience and ability to manage global or regional teams in a virtual environment.
  • Advanced 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.
  • Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies.
  • Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.
  • Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
  • Effective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables.
  • Willingness 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.

To apply, please email your resume/CV to [email protected]. In the subject line include your name and the job title.

ROLE OVERVIEW

The Medical Director/Senior Medical Director in Clinical Development will serve as the Clinical Lead for one or more oncology clinical trials. The Medical Director will work with cross-functional multidisciplinary study teams on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support in-scope aspects of global regulatory interactions.

KEY RESPONSIBILITIES

  • Serves on cross-functional teams for assigned programs, working with other team members to drive program and clinical strategy to registration in applicable populations and indications.
  • Serves as the medical monitor for assigned studies including design, execution and interpretation study data.
  • Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology and biomarker analysis plans.
  • Ensure patient safety on clinical trials and adherence to Good Clinical Practices (GCP).
  • Contribute to the development of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
  • Acts as liaison between Clinical Development and other internal groups for assigned studies, including working closely with clinical operations, pharmacovigilance, manufacturing, quality and biomarker groups to facilitate and coordinate cross-functional study activities.
  • Establishes strong collaborations with study investigators, outside medical experts and represents Mural during investigator meetings and advisory boards.
  • Contribute to the development and planning of Advisory Board meetings in the relevant therapeutic areas.
  • Support development of Target Product Profile (TPP) and Clinical Development Plan (CDP).

QUALIFICATIONS

  • MD, DO or equivalent ex-US medical degree with 4-6 years’ experience
  • ~2 years clinical trial experience
  • Pharmaceutical/Biotech industry experience in clinical development and medical monitoring
  • Strong oral and written communication skills to influence others.
  • Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
  • Ability to work independently to resolve challenges.

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.

To apply, please email your resume/CV to [email protected]. In the subject line include your name and the job title.

Interested in joining the Bicara team but don’t see an exact fit?
Please submit your CV and a quick explanation of your field of interest to [email protected]