Create the clinical development strategy for one or more assets in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing.

This position works closely with key stake holders including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations (CMO’s), and Contract Research Operations (CRO’s) to ensure seamless supply of Clinical Trial Material.

Leads clinical program(s) and acts as a clinical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards), internal stakeholders (e.g., Research, Regeneron Genetics Center, Regulatory Affairs, Global Clinical Development, Precision Medicine, HEOR), and internal decision committees.

Works cross-functionally with other internal groups (eg, Clinical Operations, Biometrics, Data Management, Pharmacovigilance & Drug Safety, Translational Medicine, Preclinical Science, Regulatory Affairs, Medical Affairs, Business Development, and New Product Planning.

This role leads one or more clinical team working closely with key stakeholders , including pre-clinical research, Regeneron Genetics Center, regulatory affairs, clinical operations, and others.

Under the direction of the Senior Director, this position collaborates and regularly meets with key stakeholders, including Clinical Research Disease Center Managers, CTO Associate Directors of Regulatory Operations, Regulatory Affairs, Network and Satellite Program, Project Management / Monitoring and Education and Training to promote excellence and streamlined collaboration in clinical research across all disease groups.

Demonstrated track record in leading cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory affairs). Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.

You will collaborate with colleagues in other functions including Study Physician, Patient Safety, Regulatory Affairs, Clinical Operations, Translational, CMC, and early development groups.

Acts as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies. Global clinical research experience and experience interacting with regulatory authorities is a plus.

Lead cross-functional teams comprised of members from diverse subject areas – including, but not limited to - clinical operations, medical, regulatory affairs, biometrics, safety, quality, and supply – to facilitate transparent communication and knowledge sharing.

The Nuvalent pipeline is currently focused on development of precision medicines for oncology targets; therefore, the physician will work closely with scientists in discovery research and translational medicine, as well as non-clinical safety, DMPK/clinical pharmacology, biostatistics, clinical operations, data management, pharmacovigilance, and regulatory affairs.

You will report to the Sr. Director, Clinical Development and will collaborate with Clinical Pharmacology, Clinical Research, Translational Medicine, Regulatory Affairs, Biostatistics, Data Management and other functions as appropriate.

Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.

Manage effective internal and external relationships, such internally with members of the executive leadership team, regulatory affairs, clinical operations and medical affairs, and externally including regulatory agencies, partners, KOLs, and investigators.

The Senior Director of Clinical Development will be responsible for overseeing and steering the design and execution of clinical trials for his/ her assigned programs, helping to create the clinical development plan for new compounds, and paving a path toward regulatory approval.