Vice President, Regulatory Affairs

Position Summary

The Vice President of Regulatory Affairs leads, directs, and implements the regulatory strategy for the Company.  The VP is responsible for regulatory strategy and recommendations to the CMO and Research and Development Leadership Team (RDLT) and for identifying the key strategic regulatory drivers for early and late-stage programs from IND/CTA to NDA/BLA/MAA.  The VP is also responsible for developing, establishing, and maintaining effective relationships with worldwide health authorities, including FDA and EMA, and oversees all Regulatory Affairs (RA) activities through both early and late-stage development, licensure, and commercialization in the US, Europe, and other regions. 

The VP is a critical member of the early- and late-stage Product Development Team (PDT) and Research and Development Leadership Team (RDLT) and works to drive proactive identification and resolution of drug development project issues.

This position is remote with a corporate headquarters in Foster City, CA and Parsippany, NJ. The Vice President will report to the Executive Vice President, R&D and Chief Medical Officer.

Primary Responsibilities

• Build and retain highly effective team of regulatory professionals, and through leadership and direct line management, facilitates personal development and training of team members to ensure successful execution of global regulatory activities and strategies for the Company’s product development programs
• Leadership of cross-function teams where appropriate to achieve corporate goals, especially where regulatory activities form a significant contribution
• Develop and implement RA strategies and plans during clinical development and in preparation for the anticipated registration filings, including ODD and PIP strategies
• Identify and assess regulatory risks, including regional and global market-related drivers
• Lead and oversee regulatory submissions for hematology/oncology products, including health authority communication strategies
• Implement and integrate best regulatory practices into pre-clinical, clinical, and CMC submissions and ensure that all regulatory submissions are appropriately reviewed, complete, scientifically accurate, and of high quality
• Lead responses to and/or resolution of regulatory inquiries from agencies and health authorities and represents RA at meetings and interactions with regulatory agencies
• Contribute to the creation of development plans that incorporate regulatory strategies designed to maximize the likelihood of successful regulatory applications, delivering regulatory approval, advantageous labeling, and reimbursement for all key indications
• Serve as a credible, influential, respected Company spokesperson during interactions with US and ex-US regulatory agencies and drive appropriate, proactive communications to assure expedient and efficient review and approval of submissions
• Monitor and anticipate regulatory and scientific advances, novel endpoints, innovative clinical trial designs, and regularly brief Company management
• Lead the preparation and management of timely regulatory submissions, including INDs, briefing documents, clinical protocols, NDAs/MAAs, fast-track, breakthrough designation, accelerated approval, and orphan drug applications
• Fulfill all requirements for ensuring reporting obligations are met, including amendments, annual reports to FDA, safety, and quality reports
• Lead and contribute to process improvement initiatives, and development of department SOPs
• Collaborate with clinical and drug safety to manage the regulatory aspects of the Company systems, and providing the regulatory oversight and reporting requirements
• Review and approval of clinical study protocols, CSRs, SAPs, DSUR, IBs, and ISS
• Collaborate on the preparation of regulatory submissions, including post-marketing commitments, safety updates, and payer evidence packages as part of RDLT Collaborate with Manufacturing and Quality to manage regulatory aspects of all CMC activities, including regulatory evaluation of CMC change controls
• Assess and align the organization to meet the goals of the long-range business plan
• Represent the Regulatory department in internal leadership forums, external presentations, and cross-functional governance bodies

Competencies

• Significant regulatory expertise in hematology/oncology drug development with deep understanding of US & EU and other regulatory requirements and environment 
• Detailed knowledge and in-depth application of GCP, GMP, FDA, and EU GVP regulations and international guidelines
• Ability to read, evaluate, and interpret complex regulatory documents and to respond effectively to sensitive inquiries or issues
• Ability to lead and collaborate across cross-functional teams, including CROs and external vendors
• Ability to successfully manage activities to timelines, lead and develop people, and work in a multi-disciplinary team environment
• People management strengths, including the ability to motivate and mentor
• Willingness to roll-up sleeves and be hands-on 
• Excellent written and verbal communication skills
• Excellent scientific analysis and interpretation skills and the ability to creatively problem solve
• Strategic mindset with the ability to drive plans for successful regulatory outcomes

Experience

• Advanced degree (MS or PhD) or equivalent preferred
• Minimum of 15 years of experience in pharmaceutical or biopharmaceutical industry, the majority in a hematology/oncology setting
• Extensive Regulatory Affairs management experience in early and late-stage clinical settings, including oversight of third-party regulatory activities, internal pharmacovigilance review processes and clinical safety assessments, reporting procedures, and risk management
• IND/NDA/MAA preparation and product registration experience, with demonstrated track record of success with drug approvals
• Drug development experience in orphan diseases

 EEO Statement: 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. 

Benefit Statement:

All regular-status, full-time employees of Geron are eligible to participate in the Company’s comprehensive benefit program, pursuant to plan terms and conditions.  Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, supplemental health insurance, a 401(k) retirement savings plan, and an employee stock purchase plan.  Geron also provides regular-status, full-time employees with a generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment, 64 hours of sick leave, 9 standard paid holiday days off, and paid leave for certain life events.  Geron recognizes that its employees work in many different states and therefore may be affected by different laws.  It is Geron’s intention to comply with all applicable federal, state, and local laws that apply to the Company’s employees.

Salary Statement:

Offered compensation is determined based on market data, internal equity, and an applicant’s relevant skills, experience, and educational background.  

General Salary Range: $320,000 to $350,000