Scismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs.

Their vision is to build a specialty, hospital-focused radiotherapeutics company that develops and markets medicines for relapsed or refractory cancer patients who are treated primarily in large quaternary care hospitals and their catchment areas. On the basis of results that demonstrate meaningful survival benefit and provide the opportunity to move the goal post in AML, the company intends to launch two drugs in five years.

The company is well-funded. Their differentiated product pipeline is further exemplified by their next-generation program for rapidly growing cell and gene therapies, as well as their solid tumor and immunotherapy collaborations with several large companies. In addition, they have several other programs in solid tumors at the pre-clinical stage with IND-enabling studies ongoing and their extensive intellectual property portfolio includes over 200 issued patents and pending patent applications worldwide.

Job Overview:

The incoming Director of RA will be a leader and key member of a dynamic team who is responsible for developing, directing and implementing the regulatory strategy for several programs with a focus on unmet medical needs in oncology. The Director will identify the key strategic regulatory drivers for early and late stage programs for submissions (from IND to BLA) to US and international regulatory agencies. This position also will be responsible for developing, establishing and maintaining effective relationships with regulatory agencies, especially the FDA, EMA and overseeing all Regulatory Affairs activities. The incoming candidate must have significant regulatory expertise in Oncology drug development with a demonstrated track record of success in terms of biologics drug approvals.

This role reports to CMO.

Key Responsibilities:

• Develop and implement Regulatory Affairs strategies and tactical work plans during clinical development and in preparation for the anticipated US filings
• Identifying and assessing regulatory risks, understanding global imperatives including market-related drivers
• Accountability for overseeing regulatory submissions for the oncology portfolio, including the associated communication strategy to all regulatory authorities.
• Ensure that sound regulatory practices are fully integrated into pre-clinical, clinical and technical submissions, and will ensure that all documents submitted to regulatory agencies are appropriately reviewed to ensure they are complete, scientifically accurate, and of high quality
• Contribute to the creation and implementation of development plans that incorporate regulatory strategies designed to maximize the likelihood of successful regulatory applications, delivering regulatory approval and reimbursement for all key indications
• Act as a credible, influential, respected spokesperson during interactions with US and international regulatory agencies, and ensure appropriate, proactive communication with agencies to assure expedient and efficient review and approval of submissions
• Monitor and anticipate regulatory & Scientific Advances, novel end-points, innovative clinical trial designs and regularly brief company management
• Present and defend regulatory plans to Senior Management.
• Lead the preparation and management of timely regulatory submissions, including INDs, briefing documents, clinical protocols, BLAs, fast-track/breakthrough/accelerated approval/orphan drug applications.
• Fulfill all requirements for ensuring all reporting obligations are met, including amendments, annual reports to FDA, safety and quality reports
• Collaborate with Medical to manage the regulatory aspects of the company Pharmacovigilance system including the establishment and review of SOPs and providing the regulatory oversight of the system managements and reporting requirements.
• Collaborate with Product Development, Manufacturing and Quality to manage regulatory aspects of all CMC activities. Perform regulatory evaluation of CMC change controls.
• Participate or lead regulatory interactions with and presentations to US FDA and other regulatory agencies
• Review and approval of Clinical Study Protocols, Clinical Study Reports, Statistical Analysis Plans, and ISS.
• Represent Regulatory Affairs on cross-functional teams. Interact collaboratively with CMC, clinical, pre-clinical, supply chain, operations and other functional management as they impact the quality of products and operations
• Evaluate and approve documentation for regulatory filings.
• Use considerable analytical and judgment skills to drive continuous improvements.
• Hybrid work schedule: 2-3 days in office are required

Qualifications:

• MS/PhD or MD in Life/Health Sciences.
• A proven leader with a minimum of 10 years pharmaceutical/biotechnology industry experience in multiple phases of development (must have both large and small company experience), 10 years regulatory experience in biotech programs.
• MUST HAVE BIOLOGICS EXPERIENCE
• Recent experience of IND, NDA and BLA submissions a must.
• Deep knowledge and understanding of drug development process, regulatory requirements and environment, especially in the US.
• Demonstrate strategic thinking and implementation in overall drug development, with experience in orphan diseases.
• Demonstrated strategic capability and ability to see the overall, 'big' picture, along with examples of showing courage and confidence to lead and implement change
• Ability to read, analyse and interpret complex regulatory documents and to respond effectively to sensitive inquiries or complaints
• Able to drive strategic thinking and plans for successful regulatory outcomes.
• Dynamic individual with excellent written and communication skills.
• Ability to set priorities, work independently and deliver results in a timely manner.
• Experience in interfacing with regulatory authorities.
• Strong planning, organizational and leadership skills.
• Strong interpersonal skills and the ability to skillfully and appropriately manage, develop and mentor personnel in a matrix environment.
• Attention to detail.
• Thorough understanding of the FDA (biologics division), including experience in PAI readiness
• Results oriented. Strong initiative, accountability and willingness to take ownership and drive projects to completion
• Experience in radiopharmaceuticals is a major plus

Compensation will be commensurate with experience. The company offers competitive base salaries, performance bonuses, equity incentive plans, 401(K) with company matching and comprehensive health benefits.