Director, Global Regulatory Affairs

Summary

NextPoint Therapeutics is an exciting development-stage Boston-area startup company working at the frontier of immuno-oncology on a novel checkpoint axis with multiple programs entering the clinic. We are currently looking for a Director of Regulatory Affairs to our fast moving, roll-up your sleeves team environment. Reporting to the Chief Medical Officer, the Director of Global Regulatory Affairs will oversee all aspects of regulatory matters, including filings and interactions with regulatory authorities. We are a nimble, innovative, and driven company and looking for an experienced individual to join our growing team.

Responsibilities

• Lead and manage preparation and submission of all regulatory documents across clinical and pre-clinical programs, including authoring where necessary.
• Provide strategic advice for maximizing regulatory success of pipeline programs.
• Contribute to cross-functional activities across programs and ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Lead and manage all interactions/meetings with FDA and other health authorities.
• Participate as an active team member across all pipeline projects and lead all regulatory activities for multiple clinical programs (including maintenance of documentation, amendments, updates as required) as well as participate in IND planning for preclinical programs.
• Ensure compliance with FDA and other regulatory guidelines across pipeline programs.

Experience and Qualifications

• Ability to collaborate across clinical, translational, and CMC teams
• At least 50% on-site presence would be expected in this integrated team environment.
• Ability to work independently, exhibit self-motivation, detailed-oriented with excellent critical thinking and problem-solving skills.
• Experience with oncology drug development required, experience in immuno-oncology drug development strongly preferred.
• Solid working knowledge of drug development process and regulatory requirements—knowledge of IHC, FDA, EMA guidelines and requirements required and knowledge/experience with Asian regulatory authorities including the Korean MFDS a plus.
• Ability to proactively identify regulatory issues and offer creative solutions and strategies, including risk mitigation strategies.
• Regulatory CMC experience for monoclonal antibodies a plus
• Experience with biomarker strategies preferred, experience with companion diagnostic development a plus.
• Experience managing annual reports, IND amendments, IB updates, DSURs for lifecycle management of our pipeline programs.
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Ability to understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy
• Strong organizational skills
• Experience with filing INDs required. Experience with direct interactions with FDA required.
• BS, MS, or PhD in Biology, Immunology, or related fields with > 7 years of industry experience inclusive of > 5 years regulatory experience

Interested in finding out more?

Please send your resume and cover letter to [email protected].