Executive Vice President Regulatory

Point Biopharma Tarrytown , NY 10591

Posted 2 weeks ago

Westchester County, NY or Indianapolis, Indiana or Toronto, Canada

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

Reporting into the Chief Executive Officer, the Executive Vice President of Regulatory will be responsible for overseeing the global strategy development and execution of the regulatory affairs objectives for POINT Biopharma.

Your responsibilities will include:

  • Accountable for POINTs global regulatory strategy and tactics
  • Designs, coordinates, directs, and conducts all global regulatory interactions
  • Develops and maintains productive relationships with global regulators, acting as primary regulatory contact with the FDA, Health Canada, European Union agencies and other international regulatory bodies
  • Optimizes the development of a precision medicine approach, with integrated drug/diagnostic regulatory and submission plans, including engagement plans and mitigation strategies for regulatory agencies
  • Manages the preparation of all global regulatory submissions (from INDs to marketing applications) to the FDA and other global regulatory agencies for precision cancer medicines and companion diagnostic tests
  • Manages on-going regulatory submission and reporting requirements
  • Provides innovative approaches to resolve complex regulatory issues and increase speed to patients
  • Builds and manages a team to support regulatory activities across programs and electronic submissions
  • Provides guidance and recommendations to key stakeholders within the organization
  • Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, NDAs, and labeling for drug and diagnostic products
  • Coordinate, author, and review document submissions to Health Authorities (e.g. Briefing Documents, Information Requests)
  • Remains current with regulatory intelligence and ensures submissions are aligned with current standards/guidance
  • Provides regulatory oversight for product development, manufacturing and distribution
  • Provides overall review, day-to-day management and operational success for all regulatory functions including the successful integration of activities cross-functionally
  • Remains on the forefront of the relevant science, competitive landscape and policy including detailed competitive intelligence and provides Executive Leadership Team with assessments of the impact of new and changing regulations on the Company's programs
  • Leads regulatory due diligence in support of business development transactions
  • Ensures adequate resourcing of the regulatory organization by anticipating needs in advance and filling gaps, as needed with consultants, contractors and/or full-time employees, responsibly helping to shepherd the company's financial resources
  • Monitors compliance with regulatory requirements and commitments
  • Holds themselves and their teams to the highest levels of integrity, in line with company values
  • Collaborates well with peers and mentors the junior staff

Requirements

  • PharmD or PhD preferred, Bachelors degree required
  • 15+ years experience in Regulatory Affairs, at least 5 years managing a regulatory team
  • Oncology experience required, including small molecules/precision medicine clinical programs; experience with and the development of companion diagnostics is highly desired
  • Proven ability in leading and directing regulatory affairs activities from pre-IND through global marketing application (e.g. NDA/BLA/MAA)
  • Direct experience in developing strategy and leading teams through interactions with health authorities
  • Track record of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components
  • Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives
  • Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
  • Excellent communication, analytical and organizational skills
  • Inherent drive to cultivate collaboration, teamwork and professionalism
  • Patient Focus: adopting patient perspective in all interactions
  • Ability to work independently, be an effective leader, and an engaged team member in a dynamic, fast-paced and lean environment
  • Nimble, creative, entrepreneurial with the ability to independently execute
  • Motivated to learn or advance own expertise and value
  • Systemically organizing and completing detailed tasks, checking accuracy and completeness of information
  • Highly attentive to detail and focused on quality
  • Results oriented and able to multi-task

Why joining POINT today will be the right career move for you:

There is no shortage of demand for smart, qualified and hardworking people like yourself and we strongly believe POINT is the right career move for you. Here is why:

  • You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
  • You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
  • You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
  • Most importantly, you will spend everyday working on something important

If what we are saying resonates with you, please submit a cover letter and resume.

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Executive Vice President Regulatory

Point Biopharma