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Senior Corporate Counsel
Refer job# KEVZ156654
Senior Corporate Counsel The candidate will be part of the Legal team that supports Pharma Oncology, Inc. (SDP Oncology), and will report to the VP, Head of Legal for SDP Oncology. Will be part of the Legal team supporting the development and commercialization of firm's robust and growing pipeline of novel cancer therapeutics. In this role will work directly with SDP Oncology's Clinical Development and Regulatory teams to support various clinical programs across all phases of clinical research by providing practical and strategic legal advice on a broad range of issues. Responsibilities will include, advising on regulatory strategy, negotiating and managing clinical contracts, and otherwise counseling internal stakeholders to ensure compliance with key healthcare laws and regulations. Support the Medical Affairs team by participating in Advisory Board planning and execution, and reviewing various scientific materials and publications to ensure compliance with legal and regulatory requirements. And will partner with the Compliance team to continuously assess and mitigate compliance risks and build strong compliance programs that are consistent with SDP Oncology's values and risk profile. Serve as a trusted legal advisor and strategic business partner to SDP Oncology's Clinical Development, Regulatory, and Medical Affairs teams. Negotiate, draft and manage all clinical operations contracts, including clinical trial agreements, investigator-initiated study agreements, and collaborative research agreements. Provide advice and guidance for SDP Oncology's regulatory strategy, including submissions and communications with FDA. Support Advisory Board planning and execution, Review protocols, informed consent forms, various scientific materials and publications, ensuring compliance with legal and regulatory requirements. Provide legal support for patient assistance and recruitment programs. Provide strategic guidance and work with Compliance colleagues to design, implement, maintain, and continually improve SDPA's and SDP Oncology's Compliance Program. Additional responsibilities as assigned.

The candidate should have J.D. Should be admitted to practice and be in good standing with a US state bar. 10 years of experience as an attorney in pharmaceutical/biotech transactions at a large law firm and/or in-house within the pharmaceutical/biotech/med device industry required. Strong negotiation and excellent legal drafting skills are required. must have strong presentation and communication skills, both written and verbal, including the ability to communicate complex legal issues in a simple, understandable manner with colleagues of varying legal knowledge. Should have Knowledge and experience in advising senior leaders regarding applicable healthcare laws and regulations, including the federal Food, Drug and Cosmetic Act (FDCA), Anti-Kickback Statute (AKS), pharmaceutical government price reporting obligations, HIPAA and HITECH patient privacy rules, False Claims Act (FCA), FDA regulations, HHS-OIG guidance, PhRMA Code, and industry best practices.

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