Director, PV Operations

Position Overview

The Director of Pharmacovigilance (PV) Operations will provide strategic and operational leadership for pharmacovigilance activities across the clinical development lifecycle, with readiness to support future post-marketing activities. This role is responsible for ensuring compliant, efficient, and high-quality safety operations in accordance with global regulatory requirements, while partnering closely with cross-functional stakeholders in a fast-paced oncology biotech environment.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Responsibilities

• Lead and oversee all PV operational activities, including adverse event intake, case processing, quality review, and regulatory reporting.

• Ensure timely and compliant submission of expedited safety reports (e.g., SAEs, SUSARs) and support aggregate safety reporting activities (e.g., DSURs, PSURs/PBRERs).

• Manage PV vendor relationships, including case processing and safety database vendors; establish and monitor KPIs, quality metrics, and service performance.

• Oversee the safety database and associated workflows to ensure data integrity, inspection readiness, and regulatory compliance.

• Develop, implement, and maintain PV SOPs, work instructions, and operational processes aligned with FDA, EMA, ICH, and global PV regulations.

• Serve as the primary PV Operations interface with Clinical Development, Regulatory Affairs, Data Management, Quality, and external partners.

• Provide operational input into clinical and regulatory documents, including protocols, Investigator’s Brochures, informed consent forms, and risk management plans.

• Support safety governance activities, including Signal Surveillance Team (SST) and Safety Review Team (SRT) meetings.

• Lead inspection and audit preparedness activities and support responses to health authority inquiries.

• Mentor and develop PV Operations staff and contribute to the growth and scaling of the pharmacovigilance function.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field required; advanced degree (MS, PharmD, PhD) preferred.

• Minimum of 8+ years of experience in pharmacovigilance within the biopharmaceutical industry.

• At least 3+ years of leadership or management experience overseeing PV operations and/or vendors.

• Strong knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH).

• Hands-on experience with safety databases, case processing, and regulatory safety reporting.

• Excellent communication, leadership, and cross-functional collaboration skills.

• Ability to operate independently and strategically in a small, evolving organization.
  Prior experience in oncology or related therapeutic areas.

• Experience supporting early- to mid-stage clinical development programs in a biotech setting.

• Experience building or scaling PV operational processes in a growing organization.
  

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.