Bicara Therapeutics
Senior Director, GCP Quality Oversight
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Bicara Therapeutics
Position Overview The Senior Director, GCP Quality Oversight candidate will manage activities related to the development, maintenance and oversight of GCP activities for clinical trials sponsored by the company. Responsibilities include ensuring quality and compliance of company-sponsored clinical trials with SOPs, regulatory requirements (US FDA, ICH, EU and country specific), and industry standards.
This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.
Responsibilities
Ensure all clinical trial activities comply with GCP guidelines, international regulations (e.g., ICH‑GCP), and applicable laws.
Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements.
Plan, conduct, and/or participate in internal audits and external inspections to assess GCP compliance and identify areas for improvement.
Develop and deliver internal training programs on GCP principles, regulations, and best practices for relevant stakeholders.
Collaborate with cross‑functional teams to identify potential internal or external risks to GCP compliance and develop mitigation strategies.
Maintain and enhance Bicara Therapeutics’ QMS by implementing processes and procedures that ensure consistent adherence to GCP standards throughout the clinical trial lifecycle.
Investigate deviations, non‑compliances, and quality issues related to GCP and develop CAPAs to prevent recurrence and improve processes.
Evaluate and monitor the performance of third‑party vendors, including contract research organizations (CROs), to ensure compliance with GCP requirements.
Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and quality of GCP‑related processes and procedures.
Qualifications
Bachelor's degree in life sciences, pharmacy, nursing, or a related field.
Minimum of 10 years of experience in quality assurance within the pharmaceutical/biotech industry, with a focus on GCP compliance.
Subject matter expert in GCP guidelines, ICH‑GCP, FDA regulations, and other relevant regulatory requirements.
Experience conducting GCP audits, inspections, and vendor qualifications/assessments.
Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external stakeholders.
Detail‑oriented mindset with a proactive approach to problem‑solving and decision‑making.
Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable.
Company Overview Bicara Therapeutics is a clinical‑stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds human transforming growth factor beta (TGF‑β). This dual‑targeting mechanism may provide potent anti‑tumor activity by blocking both EGFR survival and proliferation and TGF‑β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma and other solid tumor types.
For more information, visit www.bicara.com or follow us on LinkedIn or X.
EEO Statement 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.
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at
Bicara Therapeutics
Position Overview The Senior Director, GCP Quality Oversight candidate will manage activities related to the development, maintenance and oversight of GCP activities for clinical trials sponsored by the company. Responsibilities include ensuring quality and compliance of company-sponsored clinical trials with SOPs, regulatory requirements (US FDA, ICH, EU and country specific), and industry standards.
This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.
Responsibilities
Ensure all clinical trial activities comply with GCP guidelines, international regulations (e.g., ICH‑GCP), and applicable laws.
Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements.
Plan, conduct, and/or participate in internal audits and external inspections to assess GCP compliance and identify areas for improvement.
Develop and deliver internal training programs on GCP principles, regulations, and best practices for relevant stakeholders.
Collaborate with cross‑functional teams to identify potential internal or external risks to GCP compliance and develop mitigation strategies.
Maintain and enhance Bicara Therapeutics’ QMS by implementing processes and procedures that ensure consistent adherence to GCP standards throughout the clinical trial lifecycle.
Investigate deviations, non‑compliances, and quality issues related to GCP and develop CAPAs to prevent recurrence and improve processes.
Evaluate and monitor the performance of third‑party vendors, including contract research organizations (CROs), to ensure compliance with GCP requirements.
Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and quality of GCP‑related processes and procedures.
Qualifications
Bachelor's degree in life sciences, pharmacy, nursing, or a related field.
Minimum of 10 years of experience in quality assurance within the pharmaceutical/biotech industry, with a focus on GCP compliance.
Subject matter expert in GCP guidelines, ICH‑GCP, FDA regulations, and other relevant regulatory requirements.
Experience conducting GCP audits, inspections, and vendor qualifications/assessments.
Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external stakeholders.
Detail‑oriented mindset with a proactive approach to problem‑solving and decision‑making.
Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable.
Company Overview Bicara Therapeutics is a clinical‑stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds human transforming growth factor beta (TGF‑β). This dual‑targeting mechanism may provide potent anti‑tumor activity by blocking both EGFR survival and proliferation and TGF‑β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma and other solid tumor types.
For more information, visit www.bicara.com or follow us on LinkedIn or X.
EEO Statement 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.
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