Senior Vice President, Global Regulatory Affairs
AskBio’s rapid and continued advancement of its therapeutic programs has led us to seek a Senior Vice President, Global Regulatory Affairs to lead and guide our critical regulatory strategy. As a partner to the company’s executive team, reporting to the Chief Executive Officer, this new role will develop and provide strategic leadership for our growing business and ensure operational excellence across all aspects of the regulatory affairs function.
Reports to: Chief Executive Officer (CEO)
Direct reports: VP, Regulatory Affairs and Director, Regulatory Affairs
Other key relationships: Executive Leadership Team, Board of Directors
- Design, execute and lead an effective global regulatory strategy in alignment with AskBio’s overall development plan and corporate objectives
- Develop and implement near- and long-term global regulatory strategies that consistently focus on achieving a solid basis and earliest opportunity for regulatory approval
- Lead day-to-day management of key clinical regulatory functions and supporting processes leading to product related regulatory filings
- Oversight and integral involvement in the technical assessment of regulatory activities
- Address and negotiate favorable aspects of a program, allowing for the most effective and efficient pathways to benefit patients
- Lead and supervise submissions throughout a product’s life cycle, including INDs and BLAs, in addition to expedited designation requests including breakthrough, orphan drug, fast track, and rare pediatric disease designations, where appropriate
- Lead and drive the planning, strategy, content and execution of BLA filing, approval and post-approval commitments including label extension and life cycle management
- Guide and lead teams in a cross-functional organization to partner and work effectively with all aspects of R&D including research, clinical, process development, quality, regulatory, program management and CMC areas
- Work closely with other disciplines to prepare and execute global development programs
- Interface and establish productive relationships with the FDA and all other appropriate agencies
- Attract, mentor and develop talent and direct reports in the executive’s regulatory purview and broadly across the organization
- Maintain a current knowledge of the regulatory environment by reviewing and implementing current policies/practices issued by federal and international regulatory agencies
CANDIDATE SPECIFICATION: Key Selection Criteria
The ideal candidate for this senior-most regulatory role at AskBio will possess 15+ years’ experience with a tenured progression representing increasing levels of responsibility in regulatory affairs leadership roles, in addition to a record of successful drug submissions and approvals. Strong leadership competencies and the ability to drive both a strategic and tactical perspective are required to ensure sound regulatory and compliance practices are fully integrated across non-clinical, clinical and post-marketing activities. A successful record of developing relationships with the FDA, as well as other leading international agencies on a worldwide basis, is imperative.
The Senior Vice President, Global Regulatory Affairs will bring a fully formed understanding of the gene therapy landscape and easily reference past regulatory involvement with novel biological program development at the FDA and EMA. Candidates should possess a depth of experience leading submission processes for novel entities in the biological and gene modification fields. Specific regulatory experience with AAV-supported therapies is ideal, and/or experience supporting alternate gene/cell modalities including gene editing (CRISPR/Cas9, Talen, ZFN), CAR-T and adoptive cell therapies, oligo/RNA approaches, nanoparticle, and other gene modification technologies, is considered highly beneficial. Global experience with gene therapy programs is an important consideration.
While an advanced scientific or medical degree is ideal, an understanding of the drug development and life cycle management process combined with expertise in compliance is an essential priority. Past reference to design, writing and submission of regulatory filings and correspondence within a similarly complex biological or gene therapy organization is required.
This senior regulatory executive will possess excellent oral and written communication skills, as well as an ability to build relationships cross-functionally and work collaboratively with other groups. He/She will demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards.
- M.D., Ph.D. or M.D./Ph.D.
- Deep knowledge of the competitive landscape of, and connectivity within, the field of gene therapy is highly preferred
- 15+ years’ experience in cross-functional scientific and regulatory leadership within the biopharmaceutical industry; experience in translational research through product registration is ideal
- Thorough knowledge of relevant FDA regulations and guidelines, including direct experience interacting with FDA and other international health authorities; thorough knowledge of GCP and ICH guidelines; proven responsibility for the development of biological drug candidates through regulatory milestones is required
Other Personal Characteristics
- Proven leadership capabilities with excellent interpersonal skills; proven ability to engender collaboration and confidence internally and externally
- Proven ability to communicate effectively to a range of audiences, including the CEO, Executive Committee, Board of Directors, investors, external collaborators and stakeholders and at all levels within the company
- A science-driven, data-driven sensibility; a passion for cutting-edge science and medicine and a desire to move the needle with groundbreaking technologies and compelling supportive data
- Demonstrated ability to operate in an entrepreneurial, collaborative setting; values efficient decision-making and regularly gathers and incorporates input from team members at all levels and across functional areas
- Demonstrated track record of effectively influencing decisions inside an organization, overcoming obstacles and driving efforts to completion
- Reputation in previous organizations as a team player and a collaborative colleague
- Excellent strategic planning, organizational and creative problem-solving skills
We are prepared to offer the successful candidate a competitive compensation and benefits package commensurate with seniority and depth of experience.