Senior Clinical Scientist Director

Summary

Join Generate:Biomedicines, a leading biomedicines company, as a Senior Director Clinical Scientist in our Research & Development team. You will play a pivotal role in managing Phase 1-3 clinical trials for our biologic drug candidates. This involves close collaboration with cross-functional teams and external partners, ensuring scientific integrity and regulatory compliance. Responsibilities include designing and implementing clinical trials, preparing clinical documents, and engaging with key opinion leaders. The ideal candidate possesses a PhD or equivalent experience and extensive experience in clinical trials and medical writing. The position is based in Somerville, MA, with remote US options considered.

Requirements

• PhD in a scientific field of study and ten (10) years of related experience; or Master’s degree in a scientific field of study and twelve (12) years of related experience; or Bachelor’s degree in a scientific field of study and fifteen (15) years of related experience; or eighteen (18) years of related experience
• Hands-on experience with Phase 1-3 clinical trials and medical writing
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials
• Excellent communication skills, both written and verbal, with experience in medical writing
• Ability to work in a fast-paced, dynamic environment with a high degree of independence
• Experience with regulatory submissions (IND, BLA) and interactions with the FDA or other regulatory agencies
• A record of consistent professionalism, particularly when under pressure
• Strong organizational skills with an ability to work on multiple projects at various stages, concurrently
• High standards for themselves, colleagues and reports. Willingness to have difficult conversations for the sake of advancing company strategy and patient well-being
• Open-mindedness and creativity to new methods and bold strategies

Responsibilities

• Participate in the design and implementation of Phase 1, 2, and 3 clinical trials, ensuring scientific integrity and alignment with strategic objectives
• In some programs, may play the role of Study Manager
• Play a key role in the set-up and advancement of clinical trials with registrational intent
• Collaborate with diverse stakeholders as listed above and external partners (CROs, investigators) to monitor trial progress, ensure protocol adherence, and manage timelines
• Assist in preparing and reviewing clinical study protocols, amendments, informed consent forms, and investigator brochures
• Provide scientific input during site selection, investigator meetings, and site monitoring activities
• Lead and contribute to the preparation of clinical study reports, clinical sections of regulatory submissions (IND, BLA), and other relevant documents
• Author personally, and in other cases collaborate with medical writers and contribute to manuscripts, abstracts, and presentations for scientific conferences and publications
• Ensure all clinical documentation complies with Good Clinical Practice (GCP) guidelines and regulatory requirements
• Serve as a clinical/scientific resource for internal teams and external partners (CROs, regulatory agencies)
• Engage with key opinion leaders (KOLs) and investigators to incorporate feedback and insights into trial design and execution
• Support the preparation of clinical components for regulatory submissions (e.g., INDs, NDAs, BLAs)
• In collaboration with colleagues in biometrics and data management, lead activities related to data generation and validation, clinical data review and query resolution
• Participate in meetings with regulatory authorities to present clinical data and respond to inquiries

Preferred Qualifications

• Experience with clinical operations
• Experience in small and large companies

Benefits

Remote US based talent considered