Associate Director, GRS Heme​/Onc

Associate Director, GRS Heme/Onc

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this work transforms the lives of patients and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams.

• In conjunction with the Team leader, develop global regulatory strategy in development and through life cycle management taking into account relevant guidance, commercial needs, and company objectives.
• Lead regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, and supplements) utilizing internal and external resources; ensure appropriate quality controls for compliant submissions.
• Work with cross‑functional groups to define and manage contributions to submissions.
• Participate in or lead the regional Regulatory Sub‑team for assigned product(s)/project(s).
• Write regulatory documents (e.g., new INDs, briefing book content, BTL designation request, Priority Review Requests, ODD); review core documents to support IND/BLA/NDA in conjunction with EUL or GRL as needed.
• Contribute to cross‑functional rapid‑response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
• Participate in and/or lead regulatory interactions with FDA as assigned.
• In collaboration with the global regulatory team (GRT), develop global submission plans and Health Authority interaction plans.
• Solid scientific background (PhD, MD, Pharm.D., BS or MS in regulatory science) and 4‑8 years pharmaceutical industry experience; 3‑5 years significant experience in regulatory affairs.
• Thorough knowledge of the drug development process, IND and NDA process.
• Demonstrated experience in preparing FDA submissions; strong experience with US Regulatory submissions and dossiers (e.g., INDs; NDAs).
• Interdependent partnering skills, team‑oriented and ability to influence outcomes.
• Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance.
• Must be able to innovate, analyze and solve problems with minimal supervision.
• Demonstrates ownership of results within and beyond area of responsibility.
• Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
• Looks for opportunities for continuous improvement.
• Strong team player, using internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals.
• Communicates opinions, facts and thoughts with clarity, transparency, and honesty.
• Experience applying project management techniques within teams and managing meetings.
• Experience developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
• Demonstrated ability to facilitate issue resolution and conflict management, negotiate and influence others, drive quality decision making, organize and prioritize tasks, and negotiate.
• Demonstrated ability to coordinate global activities.
• Some travel may be required.

• PhD, MD, Pharm.
  
  D., BS or MS in regulatory science or related field.
• 4‑8 years of pharmaceutical industry experience.
• 3‑5 years of significant experience in regulatory affairs with mandatory FDA submissions.
• Proven knowledge of mandatory regulatory submission processes (IND, BLA, NDA).
• Strong experience with US regulatory submissions and dossiers.
• Team‑building and influencing skills; ability to lead cross‑functional initiatives.
• Data‑driven analytical and problem‑solving abilities with independent decision making.
• Ownership mindset and results orientation.
• Excellent communication skills.
• Project‑management experience.
• Experience developing regulatory strategies aligned with clinical plans and marketing objectives.
• Travel flexibility.

Princeton…