Associate Director, Safety Scientist

Bicara Therapeutics is seeking a skilled and versatile Associate Director, Safety Scientist to join our growing Drug Safety team. This critical role provides scientific expertise for medical safety tasks. Core responsibilities include safety data review and analysis from different sources, periodic report authoring and the oversight of the safety surveillance activities for the assigned program(s). The successful candidate will bring hands-on pharmacovigilance experience, a strong understanding of global safety regulations, and a proactive approach to cross-functional collaboration. This position is ideal for a PV professional looking to expand their scope and impact in a dynamic biotech environment.

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

• Perform cumulative safety data reviews across trials or indications to assess safety profiles and identify emerging risks or trends.

• 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.

• Collaborate with Safety Physicians to review and align on safety data conclusions for informed decision-making regarding assigned program(s).

• Lead preparation of aggregate safety reports (e.g., DSURs) from kick-off to submission to applicable health authorities.

• Provide input into regulatory submissions (e.g., BLA, Module 2.7.4/2.5) and respond to Health Authority queries with scientifically sound responses.

• Contribute or be the primary safety contact person for clinical trial-related documents including Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Statistical Analysis Plans (SAPs), and eCRF setup.

• Mentor new team members by providing training on core safety processes and fostering their development within the organization.

• Act as Subject Matter Expert during audits and inspections for key safety processes such as Safety Surveillance and aggregate report generation.

• Lead the safety governance meetings and develop meeting materials (agenda, minutes, slide preparation).

• Additional activities as assigned at the discretion of the hiring manager.
  

• Advanced degree (PharmD, PhD, MD, or MS) in a life sciences discipline, or equivalent scientific background is required.

• 4+ years of experience in pharmacovigilance or clinical development within a pharmaceutical or biotechnology company.

• Familiarity with global pharmacovigilance regulations (FDA, EMA, ICH, CIOMS) and safety databases (e.g., Argus, ArisGlobal).

• Expertise with Microsoft Word, PowerPoint, SharePoint and Excel.

• Excellent written and verbal communication skills, with a track record of high-quality safety document contributions.

• Ability to collaborate effectively across functions, drive timelines, and maintain compliance standards.

Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. 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.