Job Description
BioCrest Therapeutics is seeking a visionary Senior Clinical Research Scientist to join our dynamic team in the heart of Cambridge’s biotech hub. This is a high-impact opportunity to lead late-stage clinical trials that bring life-saving therapies to patients globally.
As a key member of our Clinical Development department, you will bridge the gap between scientific discovery and clinical application. You will be responsible for ensuring that our trials are designed with scientific rigor, executed with precision, and comply with the highest global regulatory standards. If you are a strategic thinker with a passion for oncology and patient-centric innovation, we want to hear from you.
Responsibilities
- Lead the strategic design, development, and refinement of Phase II and III clinical trial protocols.
- Serve as the primary scientific lead for cross-functional study teams, ensuring total alignment with global clinical development plans.
- Direct the selection and performance management of Clinical Research Organizations (CROs) and specialized vendors.
- Author and provide expert review for critical regulatory submissions, including INDs, NDAs, and Clinical Study Reports (CSRs).
- Analyze complex clinical datasets to identify and interpret safety trends and efficacy signals.
- Provide ongoing scientific and clinical guidance to trial sites, investigators, and medical monitors.
- Present clinical data findings and strategic updates to executive leadership and external scientific advisory boards.
Qualifications
- Ph.D., PharmD, or MD in Life Sciences, Pharmacology, or a related clinical discipline.
- Minimum of 7 years of progressive clinical development experience within the pharmaceutical or biotechnology industry.
- Deep expertise in ICH-GCP guidelines, FDA regulations, and EMA requirements.
- Proven track record of success in Oncology, Immunology, or Rare Disease therapeutic areas.
- Exceptional analytical skills with proficiency in clinical data visualization and EDC systems.
- Demonstrated leadership capability with the ability to influence stakeholders in a matrixed environment.
- Outstanding written and verbal communication skills for high-level scientific reporting.