Clinical Scientist (Consultant)
Boston, Massachusetts, or Remote
We are collaborating with a clinical-stage biotechnology company looking for a highly motivated and experienced Clinical Scientist to join their clinical development team, with a focus on the design, execution, and management of Phase 3 clinical trials.
The Clinical Scientist will be key in driving our clinical programs forward, ensuring the production of high-quality data, and supporting the successful regulatory submissions.
Key Responsibilities:
- Work closely with cross-functional teams, including Clinical Operations, Medical Affairs, Biostatistics, and Regulatory Affairs, to design scientifically robust late stage trials.
- Assist in developing study protocols, investigator brochures, informed consent forms, and other critical study documents.
- Serve as the scientific lead for assigned Phase 3 studies, ensuring compliance with clinical trial protocols and regulatory requirements.
- Offer continuous scientific and clinical input throughout trial execution, including participation in investigator meetings, site initiation visits, and study monitoring activities.
- Respond to protocol-related inquiries from investigators and site staff.
- Assist in preparing regulatory submissions, including clinical study reports (CSRs) and documentation for Investigational New Drug (IND) and New Drug Application (NDA) filings.
- Participate in the preparation of abstracts, presentations, and manuscripts for scientific meetings and publications.
- Partner with Medical Directors to develop and execute clinical development strategies.
Minimum Qualifications:
- Advanced degree in a scientific discipline (PhD, PharmD, MD, or equivalent) required.
- Minimum of 2-4 years of experience in clinical research, with a focus on Phase 3 trials preferred.
- Experience in a specific therapeutic area (highly prefer renal/kidney, if not then oncology, cardiology, or rare diseases) relevant to the company’s pipeline.
- Comprehensive understanding of drug development processes and GCP guidelines.
- Proven ability to interpret and synthesize clinical and scientific data.
- Strong written and verbal communication skills, with experience preparing regulatory documents and scientific publications.
