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Head Of Oncology Regulatory Affairs
Cambridge , MA 02138
Posted 2 months ago
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KSQ Therapeutics is pioneering High-Confidence Drug Development: a fundamentally new approach to R&D where the majority of the de-risking work is done prior to the generation of therapeutic drug candidates. Powered by our proprietary CRISPRomics drug discovery engine, our team has elucidated the function that each human gene plays in multiple diseases, providing a unique and more comprehensive understanding of disease biology. The quality of these insights enables our scientists to rapidly identify and validate high-confidence, patient-tailored, novel drug targets and then focus our collective efforts on the development of medicines with the greatest potential to impact the lives of patients. KSQ has initiated a pipeline of preclinical discovery programs and was founded in 2015.
Head of Oncology Regulatory Affairs
KSQ is seeking a Head of Regulatory Affairs to oversee all regulatory aspects pre-clinical, CMC, and clinical oncology drug development. This includes the development and implementation of regulatory strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements. The ideal candidate for this role is an individual who has significant regulatory experience particularly in the area of oncology, who is excited to take on new challenges in a fast-paced and dynamic start-up environment. This position will support activities such as:
- Development and implementation of regulatory strategy.
- Working actively with the basic scientists and the drug discovery teams to position our programs for accelerated drug development anticipating challenges and implementing risk mitigation strategies.
- Ensuring the organization is CMC ready for IND filing and ultimately commercial launch
- Representing the regulatory function on cross-functional development teams.
- Providing regulatory guidance and strategy including identifying and assessing regulatory risks.
- Planning, preparing, and reviewing submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA).
- Leading regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance.
- Ensuring effective collaborations with CROs and other external partners
- Managing the regulatory aspects of products and projects including achievement of timelines and deliverables.
- Monitoring, analyzing, and disseminating intelligence on regulatory matters that may affect ongoing development programs.
- Preparing meeting requests, briefing documents, coordinating and preparing teams for meetings, and interface with regulatory authorities; be primary liaison with regulatory authorities for day-to-day interactions.
- Authoring and otherwise preparing responses to requests for information from regulatory authorities.
The Right Candidate
- The ideal person for this role will possess PhD or PharmD in a scientific discipline preferred along with at least 7 years of experience in industry related Regulatory Affairs (or BS/MS with at least 10 years of relevant experience).
- Experience in the Oncology therapeutic area is critical
- Knowledge and understanding of global regulations and guidelines.
- Previous experience in the preparation and submission of regulatory documents.
- Previous experience leading a company to prepare for major health authority interactions (e.g., IND, FDA preNDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.).
- Must be able to collaborate and work with external consultants and partners (CROs) and cross-functional, internal departments such as Clinical, Commercial, Finance, Research & Development, Manufacturing, etc.
- Ability to work in a fast-paced, start-up environment.
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- Candidates must be authorized to work in the U.S.