Job Description
Are you ready to pioneer the next generation of life-saving therapies? BioCure Therapeutics is seeking a high-caliber Senior Clinical Research Scientist to join our high-growth Oncology R&D division in Cambridge, MA. This is a high-impact role where you will bridge the gap between scientific discovery and clinical application, driving the strategy for Phase II and III global trials.
In this position, you will work alongside world-class investigators to design innovative study protocols and interpret complex data sets that shape the future of cancer treatment. We offer a culture of scientific excellence, premium benefits, and the opportunity to see your work directly improve patient outcomes.
Responsibilities
- Lead the design and development of clinical study protocols, case report forms, and informed consent documents.
- Provide expert scientific oversight for global Phase II-III clinical trials, ensuring data integrity and adherence to study objectives.
- Analyze and interpret complex clinical data, identifying trends and generating high-level summaries for regulatory submissions.
- Collaborate cross-functionally with Medical Affairs, Biostatistics, and Regulatory teams to drive clinical development plans.
- Act as the primary scientific point of contact for Clinical Trial Managers and external Contract Research Organizations (CROs).
- Author clinical study reports and present findings at international scientific congresses and advisory boards.
- Ensure strict compliance with ICH-GCP guidelines and global regulatory requirements (FDA, EMA).
Qualifications
- Advanced degree (PhD, PharmD, or MD) in Life Sciences, Pharmacology, or a related field is required.
- Minimum of 7 years of clinical research experience within the pharmaceutical or biotechnology industry.
- Proven track record of success in oncology or immunology clinical development.
- Exceptional analytical skills with the ability to synthesize complex scientific and medical data.
- Deep expertise in GCP, ICH guidelines, and the regulatory filing process (NDA/BLA).
- Strong leadership and communication skills, with the ability to influence stakeholders at all levels.
- Experience managing relationships with global CROs and external investigators.