Bicara Therapeutics
PositionOverview
The Senior Director, GCP Quality Oversight candidate will manage activities related to the development, maintenance and oversight of GCP activities related to the Clinical Trial activities sponsored by the company. The primary responsibilities will be to ensure both quality and compliance of company sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (US FDA, ICH, EU and country specific), along with current industry standards and practices.
ThisroleisbasedinourBostonofficeandfollowsahybridschedule,withthreein-officedayseachweek.
Responsibilities
EnsurethatallclinicaltrialactivitiescomplywithGCPguidelines,internationalregulations(e.g.,ICH-GCP),andapplicablelaws.
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 to address them effectively.
MaintainandenhanceBicaraTherapeutics’QMSbyimplementingprocessesandproceduresthatensureconsistentadherencetoGCPstandardsthroughouttheclinicaltriallifecycle.
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'sdegreeinlifesciences,pharmacy,nursing,orarelatedfield.
Minimum of 10 years of experience in quality assurance within the pharmaceutical/biotech industry, with a focus on GCP compliance.
SMEinGCPguidelines,ICH-GCP,FDAregulations,andotherrelevantregulatoryrequirements.
ExperienceconductingGCPaudits,inspections,andvendorqualifications/assessments.
Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external stakeholders.
Detail-orientedmindsetwithaproactiveapproachtoproblem-solvinganddecision-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 to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn or X.
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.
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ThisroleisbasedinourBostonofficeandfollowsahybridschedule,withthreein-officedayseachweek.
Responsibilities
EnsurethatallclinicaltrialactivitiescomplywithGCPguidelines,internationalregulations(e.g.,ICH-GCP),andapplicablelaws.
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 to address them effectively.
MaintainandenhanceBicaraTherapeutics’QMSbyimplementingprocessesandproceduresthatensureconsistentadherencetoGCPstandardsthroughouttheclinicaltriallifecycle.
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'sdegreeinlifesciences,pharmacy,nursing,orarelatedfield.
Minimum of 10 years of experience in quality assurance within the pharmaceutical/biotech industry, with a focus on GCP compliance.
SMEinGCPguidelines,ICH-GCP,FDAregulations,andotherrelevantregulatoryrequirements.
ExperienceconductingGCPaudits,inspections,andvendorqualifications/assessments.
Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external stakeholders.
Detail-orientedmindsetwithaproactiveapproachtoproblem-solvinganddecision-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 to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn or X.
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.
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