Senior Director – Vice President, Pharmacology

Position Overview:

The Vice President of Clinical Pharmacology at Bicara Therapeutics will play a critical role in leading and shaping the company’s clinical pharmacology strategy, with a focus on advancing our oncology pipeline. You will be responsible for overseeing the design, development, and execution of clinical pharmacology studies, ensuring they align with regulatory requirements and support the progression of our investigational therapies through clinical trials. This is a leadership position that requires close collaboration with cross-functional teams, including clinical development, regulatory affairs, and project management.

Key Responsibilities:

• Leadership & Strategy: Lead and manage the clinical pharmacology team to drive the clinical development strategy and ensure pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction assessments are integrated into all stages of clinical trials.
• Clinical Study Design: Develop and oversee the design and implementation of clinical pharmacology studies (e.g., dose escalation, PK/PD modeling) for oncology drug candidates, ensuring optimal dosing strategies and evidence generation.
• Regulatory Compliance: Provide pharmacology expertise and strategic guidance to ensure clinical studies meet regulatory requirements and align with global health authority expectations (FDA, EMA, etc.).
• Collaboration: Work cross-functionally with clinical development, medical affairs, regulatory affairs, and translational medicine teams to support the design, execution, and interpretation of clinical studies.
• Data Analysis & Interpretation: Oversee the analysis and interpretation of clinical pharmacology data to provide insights into dose optimization, safety profiles, and clinical pharmacology models.
• External Relationships: Foster relationships with external scientific and clinical experts, KOLs (Key Opinion Leaders), and regulatory agencies to ensure best practices and keep up to date with industry trends.
• Team Development: Build, mentor, and grow a high-performing clinical pharmacology team while fostering a culture of collaboration, innovation, and excellence.
• Clinical Trial Management: Work closely with project management teams to ensure the timely execution of clinical trials, manage budgets, and ensure resources are appropriately allocated.
• Publications & Presentations: Contribute to scientific publications and presentations at industry conferences to enhance the company’s scientific reputation and communicate clinical pharmacology findings.

Qualifications:

• PhD or PharmD in Pharmacology, Pharmaceutical Sciences, or a related field.
• Minimum of 10-15 years of experience in the pharmaceutical or biotechnology industry, with at least 5 years in a senior leadership role in clinical pharmacology.
• Expertise in oncology pharmacology, including PK/PD modeling, dose escalation studies, and drug development strategies.
• Strong knowledge of regulatory requirements and guidelines for clinical trials in oncology.
• Proven ability to lead and mentor a team of clinical pharmacologists and collaborate effectively with cross-functional teams.
• Excellent communication skills, both written and verbal, with experience presenting to senior leadership, regulatory agencies, and external stakeholders.
• Experience in managing clinical trial budgets, timelines, and resources effectively.
• A strong track record of contributions to clinical pharmacology publications and presentations at major industry conferences is highly 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.