Join Us: Careers & Culture

At Bicara, we bring together the agility and passion of a startup with the confidence and focus of an established biopharma. Our team is dynamic, diverse and driven — and we have proven that we can deliver, with a first IND and lead program already in the clinic.

Together, we are determined to bring high-impact, first-in-class medicines to cancer patients.

Interested in joining the Bicara team?

POSITION SUMMARY

The Senior Director, Pharmacovigilance & Safety will be responsible for leading the pharmacovigilance function, providing leadership and clinical support to drug safety data management and interpretation and risk management activities for Bicara with a primary focus on our lead asset, BCA101, including oversight of clinical trial Serious Adverse Event (SAE) processing and safety data analysis to support signal detection and risk/benefit profile evaluation. This individual will ensure timely, consistent, and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP) and standard operating procedures (SOPs). This position will report to the Executive Medical Director who focus on late stage clinical development.

KEY RESPONSIBILITIES

  • Manage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks for our lead asset BCA 101 in Phase I-III development as well as future pipeline assets in early development.
  • Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, and medical review of individual case reports of serious adverse events.\Address safety-related topics as a member of the Clinical Leadership Team.
  • Work with Medical Directors, CRO Safety Physicians, and Clinical Scientists on safety monitoring and assessment activities, including:

o  Ensure that the all-development team members understand the fundamentals of pharmacovigilance, according to their roles in the organization, so they can understand and support, when needed, the PV-related activities.

o  Constant evaluation of the effectiveness of the Drug Safety system.

  • Oversight of the Drug Safety system(s) and when necessary, communicate recommended changes to assure:

o  Proactively recommend and plan for future development of Drug Safety and Pharmacovigilance to enable regulatory filings and commercialization, including acquiring QPPV support and the participation in creating Risk Management Plans and a Pharmacovigilance System Master File.

o  Oversee drug safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizations.

o  Lead the development of and review DSURs with Medical Directors/Clinical Scientists.

o  Review safety sections on cross-functional documents, including study protocols, study reports, and regulatory reports.

o  Ensure audit and inspection readiness of the function at all times.

SKILLS, QUALIFICATIONS & ATTRIBUTES

  • Clinical Expertise in Oncology: MD preferred with a strong background in oncology, including a deep understanding of the solid tumor disease landscape, treatment modalities, and specific safety considerations related to oncology drugs. Experience in clinical practice or research within oncology is highly valuable with preferred IO experience. Clinical trial experience in late stage Phase III preferred.
  • Pharmacovigilance and Drug Safety Experience: Extensive experience in pharmacovigilance and drug safety within the pharmaceutical or biotech industry, particularly in oncology. This includes knowledge of safety regulations, risk management, adverse event reporting, and signal detection specific to oncology products. Minimum of 5 years in Drug Safety related activities in pharma/biotech preferred.
  • Regulatory Knowledge: Comprehensive understanding of regulatory requirements related to drug safety, including FDA, EMA, and other global regulatory agencies. Ability to ensure compliance with safety reporting obligations and keep abreast of evolving regulatory guidelines. Experience authoring, reviewing, and providing input to drug-safety related regulatory reports. Successful involvement in regulatory agency interactions or inspections.
  • Leadership and Management Skills: Strong leadership abilities to oversee and advise clinical teams effectively on key safety aspects. Experience in managing safety operations, including case processing, risk management plans, and safety surveillance, is essential.
  • Risk Assessment and Mitigation: Proficiency in risk assessment methodologies specific to oncology drugs. Ability to identify, evaluate, and mitigate safety risks associated with oncology treatments throughout the drug development lifecycle.
  • Drug Development Lifecycle Knowledge: Comprehensive understanding of the drug development process from an end-to-end perspective, with an emphasis on late stage development through post-marketing surveillance. Experience in contributing to safety strategies and risk management plans at different stages of drug development.
  • Communication and Collaboration: Excellent communication skills to interact effectively with cross-functional teams, regulatory authorities, and external partners. The ability to communicate complex safety information clearly and concisely is crucial.
  • Analytical and Problem-Solving Skills: Strong analytical and critical thinking skills to assess safety data, identify potential safety signals, and make data-driven decisions. The capacity to address safety-related issues and propose solutions effectively. Ability to multi-task in a fast-paced environment.
  • Continuous Learning and Adaptability: Given the dynamic nature of oncology research and regulatory landscape, a commitment to continuous learning, staying updated with the latest advancements, and adapting to changes as it relates to safety assessment in oncology is essential.
  • Ethical and Compliance Mindset: A strong commitment to ethical conduct and compliance with safety regulations and industry standards. Upholding patient safety and welfare as a top priority is fundamental.

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.

Interested in joining the Bicara team but don’t see an exact fit?
Please submit your CV and a quick explanation of your field of interest to [email protected]