Dominic Chiarelli
Associate General Counsel at Athira Pharma- Claim this Profile
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English Native or bilingual proficiency
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Spanish Limited working proficiency
Topline Score
Bio
Credentials
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Certified IRB Professional (CIP)
Council for Certification of IRB ProfessionalsAug, 2013- Oct, 2024
Experience
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Athira Pharma
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United States
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Biotechnology
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1 - 100 Employee
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Associate General Counsel
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Aug 2022 - Present
Provide legal advice and support on a wide range of matters with emphasis on clinical operations, regulatory and other compliance matters, risk management and contract and policy matters. Responsibilities include: - Review, draft and negotiate a range of contracts including research, clinical development and manufacturing contracts and other contracts as needed to support business objectives; - Provide legal advice and effective solutions for risk management to support… Show more Provide legal advice and support on a wide range of matters with emphasis on clinical operations, regulatory and other compliance matters, risk management and contract and policy matters. Responsibilities include: - Review, draft and negotiate a range of contracts including research, clinical development and manufacturing contracts and other contracts as needed to support business objectives; - Provide legal advice and effective solutions for risk management to support various functional areas, including, business development, research and development, clinical, regulatory, quality, compliance, project management, marking, IT, finance, and operations; - Work closely with other functions and advise on a wide range of contractual and legal matters; - Offer advice and support on business transactions, including preparation, review and negotiation of agreements in a variety of areas, including supply, distribution, consulting, non-disclosure, and research; - Manage corporate filings with regulatory authorities; - Coordinate prosecution and management of IP portfolio with outside counsel; - Assist with additional corporate and compliance matters in a fast-paced environment; - Develop and provide training to employees on relevant topics; and - Keep current on relevant legislative issues, laws, decisions, and regulations affecting the industry. Show less Provide legal advice and support on a wide range of matters with emphasis on clinical operations, regulatory and other compliance matters, risk management and contract and policy matters. Responsibilities include: - Review, draft and negotiate a range of contracts including research, clinical development and manufacturing contracts and other contracts as needed to support business objectives; - Provide legal advice and effective solutions for risk management to support… Show more Provide legal advice and support on a wide range of matters with emphasis on clinical operations, regulatory and other compliance matters, risk management and contract and policy matters. Responsibilities include: - Review, draft and negotiate a range of contracts including research, clinical development and manufacturing contracts and other contracts as needed to support business objectives; - Provide legal advice and effective solutions for risk management to support various functional areas, including, business development, research and development, clinical, regulatory, quality, compliance, project management, marking, IT, finance, and operations; - Work closely with other functions and advise on a wide range of contractual and legal matters; - Offer advice and support on business transactions, including preparation, review and negotiation of agreements in a variety of areas, including supply, distribution, consulting, non-disclosure, and research; - Manage corporate filings with regulatory authorities; - Coordinate prosecution and management of IP portfolio with outside counsel; - Assist with additional corporate and compliance matters in a fast-paced environment; - Develop and provide training to employees on relevant topics; and - Keep current on relevant legislative issues, laws, decisions, and regulations affecting the industry. Show less
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Zymeworks Inc.
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Canada
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Biotechnology Research
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100 - 200 Employee
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Senior Director, Legal
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Sep 2019 - Sep 2022
Key legal advisor concerning a broad range of legal, regulatory, and compliance issues attendant to clinical research and the life sciences. Includes leading contract drafting and negotiation in support of clinical, regulatory, and quality teams; analyzing and implementing strategies to address privacy legislation, FDA regulatory requirements, False Claims Act, Anti-Kick Back Statute, OIG guidance, and other possible risks or legal trends; and advising on product labeling, launch activities… Show more Key legal advisor concerning a broad range of legal, regulatory, and compliance issues attendant to clinical research and the life sciences. Includes leading contract drafting and negotiation in support of clinical, regulatory, and quality teams; analyzing and implementing strategies to address privacy legislation, FDA regulatory requirements, False Claims Act, Anti-Kick Back Statute, OIG guidance, and other possible risks or legal trends; and advising on product labeling, launch activities, promotional and educational activities, reimbursement, and interactions with healthcare professionals. Show less Key legal advisor concerning a broad range of legal, regulatory, and compliance issues attendant to clinical research and the life sciences. Includes leading contract drafting and negotiation in support of clinical, regulatory, and quality teams; analyzing and implementing strategies to address privacy legislation, FDA regulatory requirements, False Claims Act, Anti-Kick Back Statute, OIG guidance, and other possible risks or legal trends; and advising on product labeling, launch activities… Show more Key legal advisor concerning a broad range of legal, regulatory, and compliance issues attendant to clinical research and the life sciences. Includes leading contract drafting and negotiation in support of clinical, regulatory, and quality teams; analyzing and implementing strategies to address privacy legislation, FDA regulatory requirements, False Claims Act, Anti-Kick Back Statute, OIG guidance, and other possible risks or legal trends; and advising on product labeling, launch activities, promotional and educational activities, reimbursement, and interactions with healthcare professionals. Show less
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Quorum Review - Independent Review Board
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United States
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Pharmaceutical Manufacturing
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Associate General Counsel
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Mar 2014 - Sep 2019
Provide legal support to organization regarding the laws and regulations concerning medical research, clinical trials, and healthcare within the United States and Canada. Draft, review, and negotiate organizational contracts, including service, vendor, SaaS, licensing, and partnership agreements. Serve as product counsel in development and launch of cloud based electronic consent product and support operation of customer management portal. Launch regulatory consulting service from inception… Show more Provide legal support to organization regarding the laws and regulations concerning medical research, clinical trials, and healthcare within the United States and Canada. Draft, review, and negotiate organizational contracts, including service, vendor, SaaS, licensing, and partnership agreements. Serve as product counsel in development and launch of cloud based electronic consent product and support operation of customer management portal. Launch regulatory consulting service from inception and serve as senior consultant to life sciences clients on issues ranging from protocol development, trial planning, and contract negotiation to international regulatory frameworks, privacy requirements, and data governance. Track emerging issues within the field and provide thought leadership in the form of presentations, white papers, and webinars. Show less Provide legal support to organization regarding the laws and regulations concerning medical research, clinical trials, and healthcare within the United States and Canada. Draft, review, and negotiate organizational contracts, including service, vendor, SaaS, licensing, and partnership agreements. Serve as product counsel in development and launch of cloud based electronic consent product and support operation of customer management portal. Launch regulatory consulting service from inception… Show more Provide legal support to organization regarding the laws and regulations concerning medical research, clinical trials, and healthcare within the United States and Canada. Draft, review, and negotiate organizational contracts, including service, vendor, SaaS, licensing, and partnership agreements. Serve as product counsel in development and launch of cloud based electronic consent product and support operation of customer management portal. Launch regulatory consulting service from inception and serve as senior consultant to life sciences clients on issues ranging from protocol development, trial planning, and contract negotiation to international regulatory frameworks, privacy requirements, and data governance. Track emerging issues within the field and provide thought leadership in the form of presentations, white papers, and webinars. Show less
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Seattle Children's Hospital
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Design
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Regulatory Analyst
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Oct 2009 - Apr 2014
Analyze medical research and clinical trials for consistency with FDA, OHRP, and HIPAA federal regulatory requirements. Serve as an Institutional Review Board member. Direct the institution and the investigators regarding regulatory compliance, ethical principles, and appropriateness of approval. Analyze reports of adverse events, protocol deviations, and non-compliance and generate recommendations regarding categorization, federal reporting requirements, and corrective actions. Counsel on… Show more Analyze medical research and clinical trials for consistency with FDA, OHRP, and HIPAA federal regulatory requirements. Serve as an Institutional Review Board member. Direct the institution and the investigators regarding regulatory compliance, ethical principles, and appropriateness of approval. Analyze reports of adverse events, protocol deviations, and non-compliance and generate recommendations regarding categorization, federal reporting requirements, and corrective actions. Counsel on applicability of FDA regulations to drugs, devices, and biologics, creation and maintenance of specimen and data banks, and appropriateness of data and safety monitoring. Show less Analyze medical research and clinical trials for consistency with FDA, OHRP, and HIPAA federal regulatory requirements. Serve as an Institutional Review Board member. Direct the institution and the investigators regarding regulatory compliance, ethical principles, and appropriateness of approval. Analyze reports of adverse events, protocol deviations, and non-compliance and generate recommendations regarding categorization, federal reporting requirements, and corrective actions. Counsel on… Show more Analyze medical research and clinical trials for consistency with FDA, OHRP, and HIPAA federal regulatory requirements. Serve as an Institutional Review Board member. Direct the institution and the investigators regarding regulatory compliance, ethical principles, and appropriateness of approval. Analyze reports of adverse events, protocol deviations, and non-compliance and generate recommendations regarding categorization, federal reporting requirements, and corrective actions. Counsel on applicability of FDA regulations to drugs, devices, and biologics, creation and maintenance of specimen and data banks, and appropriateness of data and safety monitoring. Show less
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Polsinelli
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Italy
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Farming
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1 - 100 Employee
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Contract Attorney
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Jan 2013 - Dec 2013
Draft terms and recommendations for clinical trial agreements and clinical services agreements to facilitate negotiation and execution. Review clinical trial materials for regulatory compliance and to identify potential institutional concerns. Draft opinions regarding appropriate contracting and regulatory approvals necessary for ancillary involvement in research or other atypical scenarios. Draft terms and recommendations for clinical trial agreements and clinical services agreements to facilitate negotiation and execution. Review clinical trial materials for regulatory compliance and to identify potential institutional concerns. Draft opinions regarding appropriate contracting and regulatory approvals necessary for ancillary involvement in research or other atypical scenarios.
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Research Assistant
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Sep 2004 - Sep 2006
Utilized genetic techniques, immunohistochemistry, molecular biology, and biochemistry to characterize a novel tumor suppressor. Presented work at international cell cycle meeting in Melbourne. Utilized genetic techniques, immunohistochemistry, molecular biology, and biochemistry to characterize a novel tumor suppressor. Presented work at international cell cycle meeting in Melbourne.
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University of Barcelona
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Spain
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Higher Education
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1 - 100 Employee
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Research Assistant
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Jun 2003 - Jun 2004
Developed a new technique to generate gene expression profiles for a Drosophila Melanogaster tissue that mimics wound healing in mammals. Author on “Extrinsic and intrinsic mechanisms directing epithelial cell sheet replacement during Drosophila metamorphosis” in Development 134, 367-379 (2007). Developed a new technique to generate gene expression profiles for a Drosophila Melanogaster tissue that mimics wound healing in mammals. Author on “Extrinsic and intrinsic mechanisms directing epithelial cell sheet replacement during Drosophila metamorphosis” in Development 134, 367-379 (2007).
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Research Associate
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Oct 2001 - Jun 2003
Generated and characterized a loss-of-function mutant for a novel tumor suppressor. Author on “Rheb promotes cell growth as a component of the insulin/TOR signaling network” in Nat Cell Bio. 2003 Jun; 5(6): 556-71. Generated and characterized a loss-of-function mutant for a novel tumor suppressor. Author on “Rheb promotes cell growth as a component of the insulin/TOR signaling network” in Nat Cell Bio. 2003 Jun; 5(6): 556-71.
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Education
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2006 - 2009
University of Washington School of Law
Doctor of Law (JD), Intellectual Property Law -
1996 - 2001
Western Washington University
Bachelor of Science (B.S.), Molecular Biology
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