We are Hiring

Senior Medical Director

Clinical Development

for

Senior Medical Director, Clinical Development

We are looking for a Medical Director/Senior Medical Director in Clinical Development will serve as the Clinical Lead for one or more oncology clinical trials. The Medical Director will work with cross-functional with our US based team and EU sites on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support in-scope aspects of global regulatory interactions. 

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Dyne

Position Responsibilities

  • Serve as the medical monitor for assigned studies including design, execution and interpretation study data.
  • Ensure patient safety on clinical trials and adherence to Good Clinical Practices (GCP).
  • Act as liaison between Clinical Development and other internal groups for assigned studies, including working closely with clinical operations, pharmacovigilance, manufacturing, quality and biomarker groups to facilitate and coordinate cross-functional study activities.
  • Provide scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology and biomarker analysis plans.
  • Support development of Target Product Profile (TPP) and Clinical Development Plan (CDP).
  • Contribute to the development of regulatory documents in support of regulatory submissions, including clinical section of IND's and CTA's, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
  • Serve on cross-functional teams for assigned programs, working with other team members to drive programs and clinical strategy to registration in applicable populations and indications.
  • Establish strong collaborations with study investigators, outside medical experts and represent Bicara during investigator meetings and advisory boards.
  • Contribute to the development and planning of Advisory Board meetings in the relevant therapeutic areas.
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Preferred Qualifications

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Know About

About
Bicara Therapeutics

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.

Product
Pipeline

Bicara Therapeutics is advancing a focused pipeline built around its proprietary bifunctional antibody platform, designed to target tumor-driving pathways while modulating the immune microenvironment. The lead candidate, BCA101 (ficerafusp alfa), is a first-in-class EGFR-targeting and TGF-β–trapping antibody currently in a pivotal Phase 2/3 trial (FORTIFI-HN01) for first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), following promising Phase 1/1b results.

Beyond BCA101, Bicara’s pipeline includes BCA-356, a preclinical bifunctional molecule targeting CAIX and IL-12 to activate localized immune responses. The company is also advancing early-stage discovery programs, including BCA-202, BCA-300, and BCA-400, which reflect its commitment to next-generation, dual-function biologics for solid tumors.

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The Elle Group

The Elle Group

Christina Cagle
Christina Cagle

I am a dedicated advocate for scientific innovation, serving as a strategic partner and collaborator. My mission is to bridge vision with execution, driving breakthroughs that transform lives. Let’s work together to shape a future where science fuels progress and creates a lasting impact.

Christina Cagle, Founder The Elle Group

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