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Bicycle Therapeutics

Clinical-stage biopharma developing Bicycle Drug Conjugates

Director Clinical Scientist

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeLexington, MA, USA

About the Job

Requirements

  • An advanced scientific or clinical degree, such as a PhD, PharmD, advanced nursing degree, or equivalent, and extensive clinical research experience in the biotech or pharmaceutical industry.
  • Experience designing and executing clinical trials, including protocol development, data analysis, and study reporting.
  • Thorough knowledge of Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines and current regulatory requirements.
  • Ability to interpret complex scientific and clinical data and translate it into actionable strategies.
  • Strong written and oral communication and presentation skills.
  • Ability to critically analyze, interpret, and present complex clinical data to internal and external audiences.
  • Experience in oncology.

Responsibilities

  • Lead scientific design of clinical studies, including providing expert input on study endpoints, patient population, and biomarker strategies.
  • Author clinical trial protocols and amendments, ensuring alignment with overall program strategy and incorporating clinical development principles.
  • Maintain current knowledge of the competitive and scientific landscape to inform innovative and effective trial designs.
  • Lead ongoing review and interpretation of clinical trial data, including safety, efficacy, pharmacokinetics, and translational data.
  • Translate complex datasets into scientific narratives and actionable insights to guide program decisions such as dose escalation and cohort expansion.
  • Partner with Biometrics and Translational Science to develop and execute analysis plans that fully explore trial data.
  • Serve as the primary clinical science expert for assigned programs and partner with the Clinical Lead and broader development team.
  • Drive scientific content for Investigator's Brochures, Clinical Study Reports, and regulatory filing sections, including INDs, CTAs, and BLAs.
  • Present scientific rationale, clinical data, and program updates to internal governance bodies and external stakeholders.
  • Collaborate with and provide scientific training to Clinical Operations, CRO partners, and clinical site staff to support trial execution.
  • Build and maintain relationships with key opinion leaders and clinical investigators in the radiopharmaceutical field.
  • Represent the company scientifically at investigator meetings, advisory boards, and scientific conferences.
  • Oversee and be accountable for clinical science components of significant and complex clinical programs.
  • Solve complex challenges in trial design and execution using creative and scientifically rigorous approaches.
  • Shape clinical development strategy for key assets and influence organization-wide priorities through scientific and clinical insights.
  • Set scientific strategy and direction for assigned clinical programs, making high-impact decisions and recommending program go/no-go decisions based on emerging data.
  • Mentor clinical scientists and team members and promote scientific rigor and strategic thinking.
  • Align Clinical, Translational, CMC, and Regulatory functions around cohesive program strategies.
  • Champion innovative clinical trial design approaches, including novel imaging endpoints and biomarker strategies.
  • Deliver high-quality clinical science advancing novel therapies for patients with high unmet medical needs.

Desired Qualifications

  • Experience in radiopharmaceutical trial design, dosimetry, and molecular imaging endpoints.

About the Company

Bicycle Therapeutics

Clinical-stage biopharma developing Bicycle Drug Conjugates

Bicycle Therapeutics develops cancer medicines using its Bicycles platform, which uses synthetic two-loop peptides to bind targets with high precision. It creates Bicycle Drug Conjugates that attach a therapeutic payload to the constrained peptide so the drug concentrates in tumor cells, sparing healthy tissue. The company, focused on solid tumors, runs multiple oncology programs in clinical trials and collaborates with major pharma as part of its development strategy. Its goal is to discover, develop, and commercialize targeted cancer therapies through its Bicycle Drug Conjugate pipeline.

Company size
201-500
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
2009

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