Scorpion Therapeutics is a precision oncology company founded in February 2020 by a preeminent group of scientists from Harvard University/Massachusetts General Hospital – Keith Flaherty, MD, Gaddy Getz, Ph.D. and Liron Bar-Peled, Ph.D. The company has raised $270M in Series A and Series B financings led by blue-chip investors, including Atlas Venture, Boxer Capital of Tavistock Group, EcoR1 Capital, LLC, Omega Funds, and Vida Venture.

Scorpion’s mission is to serve oncology patients by discovering and developing best-in-class and first-in-class, small molecule cancer medicines that address large patient segments with significant unmet medical needs. To accomplish this mission, we are building a highly collaborative team focused on the pursuit of novel approaches to small molecule drug discovery. This approach relies upon dynamic collaboration between cancer biology, proteomics, informatics, structural biology and medicinal chemistry – with the ultimate goal of realizing the full potential of targeted/precision oncology.

We are seeking a highly motivated accomplished leader to join our company in our Boston, MA office. This candidate will serve a critical role, responsible for setting and leading the global regulatory strategy and designing and managing all GxP programs and staff to ensure compliance with global laws, regulations and applicable guidance. He/she will be responsible for supporting the Company growth and infrastructure as the portfolio expands.

KEY RESPONSIBILITIES

• Oversee global regulatory strategy and global regulatory submissions (eg, INDs, CTAs, NDAs, MAAs, meeting requests, and briefing documents) in compliance with all applicable global regulatory requirements and alignment with corporate goals
• Collaborate with research, non-clinical development, CMC and clinical development to develop regulatory strategies which will maximize the value of our assets
• Serve as the primary company contact to the FDA and other competent authorities; Foster a strong relationship, partnership, and advocacy with global regulatory authorities
• Proactively identify regulatory risks to company’s programs and develop risk mitigation plans
• Serve as the company subject matter expert on regulatory trends and guidance’s and keeps company apprised of expected changes to the regulatory landscape affecting existing and future regulatory policies, regulations, and standards
• Provide training, and interpretation of regulatory guidelines or issues to personnel
• Develop and manage Global Regulatory Affairs and QA budgets
• Develop, implement, maintain, and communicate the Company’s quality strategy and programs
• Provide leadership and strategic guidance in ensuring continuous compliance with all applicable internal and external regulations, standards, policies, and procedures related to the quality, regulatory status, and performance of Company operations, processes, and products
• Design and maintain a fit-for-purpose quality management system (QMS) across the GxPs
• Ensure the qualification, selection and management of vendors and contractors through a defined qualified process
• Create and execute a plan for ensuring a state of inspection readiness and continuous improvement
• Create a process for identifying, adjudicating and remediating risks and/or compliance concerns/issues. Ensure rapid escalation of significant quality issues or concerns
• Develop fit-for-purpose company SOPs, work instructions, and other processes and ensure appropriate training and adherence.
• Ensure that company and departmental SOPs, job descriptions, and training documentation are current, relevant, and appropriately maintained

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

• Minimum of 15 years of biotech/biopharmaceutical leadership, with a demonstrated record of drug development within the life sciences industry
• M.S./PhD/PharmD preferred
• Demonstrated leadership to design and build a Regulatory and Quality organization needed to achieve company objectives
• Broad and deep regulatory agency knowledge and experience interpreting and guiding application of global regulatory requirements across multiple GxPs; Extensive exposure with multiple regulatory agencies
• Extensive experience leading, designing, writing and submission of regulatory filings and correspondence
• Ability to build and maintain effective internal and external relationships, including with cross-functional teams, individual contractors, contract research organizations, and other vendors to effectively manage all regulatory and quality related activities
• Proven ability to dissect complex issues to quickly distill key issues for discussion with regulatory authorities and guide teams (internally/externally) in the preparation of responses to regulatory questions
• Demonstrated and extensive hands-on experience in the preparation, review, and finalization of GxP policies, procedures, SOPs, trainings, and corrective actions for both early and late development programs
• Demonstrated success leading within a high growth, innovative, and rapidly changing environment
• Team builder who leads by example, employs expertise and influence to encourage collaboration across departments, levels, and groups to achieve key corporate objectives
• Excellent written and oral communication skills and the ability to effectively communicate with internal and external team members on project activities
• Strong problem solving, critical thinking and analytical skills, required to make sound decisions
• Great attention to detail; ability to organize, prioritize, delegate and adapt quickly to changing environments and priorities

Scorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Beginning October 13, 2021, Scorpion requires all new hires to be fully vaccinated against COVID-19. If you are unable to receive the vaccine due to a disability or serious medical condition, or because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation. Apply at: CAREERS@SCORPIONTX.COM

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