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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.

Position Overview

The (Sr.) Safety Scientist is a critical member of the Pharmacovigilance & Drug Safety team who will  support the risk assessment and characterization of the Company’s investigational product. The  successful candidate is expected to be equally effective working independently as well as collaboratively with cross-functional stakeholders. The individual must possess clinical knowledge and analytical skills to  ensure that safety data analyses and signal assessment reports are of high quality and in adherence to  PV industry standards and regulatory timelines. Accountability in leading and managing projects as well  as ability to analyze, interpret, and effectively communicate safety data is a key success factor for this  role.

RESPONSIBILITIES

• Serve as the Safety Lead at the study team meetings for the assigned investigational product 
• Responsible for review of aggregate safety data and signal management, including signal  detection, signal investigation, and preparation of signal evaluation reports, including input into a  design of a comprehensive safety surveillance system. 
• Establish Safety Surveillance Team (SST) and develop associated procedures (e.g, Charter)
• Lead the SST and develop meeting materials (agenda, minutes, slide preparation)
• Medical review of Individual Case Safety Reports (ICSRs) for regulatory/expedited reporting 
• Create and maintain reference safety information (RSI) in IB, company core data sheet, label  (W&P) 
• Review, contribute, and author sections of study protocol, ICF, IB, and other study specific  documents to ensure alignment with benefit-risk profile 
• Lead preparation of aggregate safety reports (e.g., DSURs) from kick-off to submission to  applicable health authorities 
• Support Risk Management Plan (RMP) related activities in preparation for MAH approval.
• Participate in regulatory submission activities (NDA, MAA) and support ad-hoc query responses  to health authorities.

QUALIFICATIONS

• MD, PharmD, PhD or equivalent  
• Minimum 3-5 years experience in Pharmacovigilance/Drug Safety pharmaceutical experience
• Excellent verbal and written communication skills. 
• Attention to detail and ability to think critically required 
• Familiarity with case processing, expedited reporting rules, and safety database

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.