Darryl Clarke - Senior Director, Darryl Clarke Enterprises

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Work Background

Bristol Myers Squibb (formerly Turning Point Therapeutics)Senior Director, Global Head of Regulatory Operations

Aug. 2022 - Aug. 2023San Diego, California, United States · RemoteManage and oversee development of all Regulatory Operational responsibilities, strategic leadership, managerial, and technical operational aspects of all health authority submissions and ensuring that the submissions are of high Quality and submitted on time. Also responsible for oversight of the compilation, archiving, and tracking of regulatory submissions and health authority correspondence using Regulatory Information Management system (RIM) in partnership with Regulatory Affairs, cross-functional teams, and strategic oversight of Veeva Vault RIM and First-line management of staff. • Established performance history of successfully leading multiple NDA/BLA, and MAA submissions. • Lead all aspects of submission publishing and archiving activities globally (INDs, CTAs, NDAs and MAAs) • Provide cross-functional leadership for complex global filings and work collaboratively with cross-functional teams. • Oversee submission planning resources, timelines and prioritization in collaboration with regulatory strategy lead and project management. • Deliver first-line management of staff. • Ensure the company follows all regulatory technical guidance requirements for all submissions globally. • Liaise with external regulatory operations vendor. • Provide strategic oversight VEEVA RIM suite. • Manage workflows (authoring, review, approval) in Veeva Vault RIM for multiple active applications. • Coordinate document lifecycle in eCTD. • Maintain proper archival of all regulatory submission documents (US and ROW) and related correspondence. • Strategic planning and implementation of future in-house ESG capabilities. • Create content plans for upcoming and in-progress regulatory submissions. • Track workflows and document/department metrics. • Format and make eCTD submission-ready documents.

Turning Point Therapeutics Senior Director, Global Head of Regulatory Operations

Jun. 2022 - Aug. 2022San Diego, California, United States · RemoteManage and oversee development of all Regulatory Operational responsibilities, strategic leadership, managerial, and technical operational aspects of all health authority submissions and ensuring that the submissions are of high Quality and submitted on time. Also responsible for oversight of the compilation, archiving, and tracking of regulatory submissions and health authority correspondence using Regulatory Information Management system (RIM) in partnership with Regulatory Affairs, cross-functional teams, and strategic oversight of Veeva Vault RIM and First-line management of staff. • Established performance history of successfully leading multiple NDA/BLA, and MAA submissions. • Lead all aspects of submission publishing and archiving activities globally (INDs, CTAs, NDAs and MAAs) • Provide cross-functional leadership for complex global filings and work collaboratively with cross-functional teams. • Oversee submission planning resources, timelines and prioritization in collaboration with regulatory strategy lead and project management. • Deliver first-line management of staff. • Ensure the company follows all regulatory technical guidance requirements for all submissions globally. • Liaise with external regulatory operations vendor. • Provide strategic oversight VEEVA RIM suite. • Manage workflows (authoring, review, approval) in Veeva Vault RIM for multiple active applications. • Coordinate document lifecycle in eCTD. • Maintain proper archival of all regulatory submission documents (US and ROW) and related correspondence. • Strategic planning and implementation of future in-house ESG capabilities. • Create content plans for upcoming and in-progress regulatory submissions. • Track workflows and document/department metrics. • Format and make eCTD submission-ready documents.

Sumitomo Dainippon Pharma Oncology Director, Head of Global Regulatory Operations

Mar. 2020 - Jun. 2022Cambridge, Massachusetts, United States · RemoteManaged and oversaw development of all Regulatory Operational strategies. Mentored Regulatory Operations staff and managed external vendors/consultants and grow department according to corporate needs. Collaborated with Regulatory Affairs staff in the execution of global regulatory submissions. Worked and liaised with cross-functional leadership and functional area vendors to ensure process alignment and quality, on-time submission deliverables. Served as Department Liaison/Contact for global network and system changes. Supported the EDMS Program by participating in system deployment activities, training, and day-to-day Administration of Veeva Submissions Vault. • Accountable for Global Regulatory Operations Publishing. • Managed Regulatory Submissions e-tracking and e-archiving and paper archiving. • Led dossier management (DM) of global marketing application activities including NDAs and MAAs, ensuring on-time delivery of quality dossiers from vendors. • Managed all publishing vendors and consultants.

Sumitomo Dainippon Pharma Oncology Director, Head of Global Regulatory Operations

Mar. 2020 - Jun. 2022Cambridge, Massachusetts, United States · RemoteSkills: System Deployment · Biotechnology · Information Systems

ALKUConsultant, Regulatory Operations & Technology

Aug. 2019 - Feb. 2020Morgantown, WV · RemoteApplied an excellent understanding of Global Regulations & Regional Submission Processes to optimize the Regulatory Operations Platforms streamlining eCTD, RDMS, SOP, RIM, Report, IDMP. Aggressively managed the technology systems and processes for all aspects of the Publishing, Document Processing, Archiving, and Automation functions. Established long-term strategy for the Regulatory teams following the internal digital strategy roadmaps. Directed the design, development and implementation of strategies for global/regional dossier management and planning. • Accountable for Regulatory Submissions Operations, Submission Management of INDs and NDAs. • Established performance history of successfully leading multiple NDA/BLA and MAA submissions.

Esperion - The Lipid Management CompanyDirector, Head of Global Regulatory Operations

Aug. 2018 - Jan. 2019Morgantown, WV · RemoteManaged and oversaw development of all Regulatory Operational strategies. Mentored Regulatory Operations staff and managed external vendors/consultants and grew department according to corporate needs. Collaborated with Regulatory Affairs staff in the execution of global regulatory submissions. Also collaborated and liaise with cross-functional leadership and functional area vendors to ensure process alignment and quality, on-time submission deliverables. Supported the EDMS Program by participating in system deployment activities, training, and day-to-day Administration of Veeva Submissions Vault • Accountable for Global Regulatory Operations Publishing • Responsible for Regulatory Submissions e-tracking and e-archiving and paper archiving • Dossier management (DM) of global marketing application activities including NDAs and MAAs, ensuring on-time delivery of quality dossiers from vendors.

SciformixDirector, Head of Regulatory Operations

Dec. 2013 - Jul. 2018Morgantown, WV · RemoteWorked in close collaboration with the Heads of each of Sciformix’s practices to implement and coordinate all aspects of regulatory operation activities as needed to support the continued development of Sciformix. Built team of 15 people (Submission Managers, Publishers & Document Specialists). • Managed and oversaw development of Regulatory Operational strategies. • Managed and mentored Regulatory Operations staff and external vendors/consultants and built department according to corporate needs. • Lead team in assessing and implementing electronic publishing/submission solutions. • Responsible for formatting, publishing, and submitting Regulatory documents (e.g., IND, BLA, MAA, CTA, CTX, IMPD) in CTD/eCTD format. • Collaborated with Regulatory Affairs staff in the execution of global regulatory submissions. • Developed style guides, templates, and Standard Operating Procedures related to Regulatory Operations activities. • Provided intra- and inter-departmental training on preparing submission-ready documents, electronic publishing and submissions. • Identified appropriate resources needed to support submission activities for all Clients. • Managed submission team in planning, scheduling and coordinating and executing regulatory submission development, based upon thorough knowledge of applicable global regulations. • Promoted standardization of submission processes with all Clients. • Lead Computer System Validation teams for numerous client’s system installations. • Counsel Clients on new technology opportunities to enhance their productivity and Business. • Responsible for Regulatory Information Management (Processes and systems)

Baxter HealthcareProject Manager, Global Regulatory Affairs Submission Project Management

Jun. 2012 - Nov. 2013Round Lake, IL · On-siteSubmissions: • Responsible for creating and maintaining the project information in IND, MAA, BLA, Annual Reports, major amendments, supplements or as requested • Understand the technology used to support all aspects of the submission and publishing process. • Lead and support new processes to move the organization to electronic submissions globally. • Lead project teams by following the business processes outlined by global initiatives • Work with project teams to coordinate all system training needed for the submissions • Implement the regulatory submission strategy and drive the submission plan. • Manage the assembly, review and technical approval for regulatory dossiers and documents for assigned products as needed. Project Management: • Identify appropriate resources needed to support submission activities. • Manage submission team in planning, scheduling and coordinating and executing regulatory submission development, based upon thorough knowledge of applicable regulations. • Promote standardization of submission processes within the organization. • Manage and report submission updates against milestones with areas of risk which could jeopardize submission timelines with resolution. Additional Responsibilities: • Manage and lead the people, processes and technology required to facilitate the production and management of regulatory submissions to include resource management, team composition and communication while maintaining positive relationships. • Ensure the use of appropriate document policies and standards to create “Regulatory Submission Ready” documents. • Contribute to the implementation, maintenance and continuous improvement of the submission process in the ICH regions. • Communicate with customers of technical requirements for source documents, through the provision of templates and company policies and standards, and by way of timely updates or changes. • Identify, manage and support RA and RO process improvements.

DCRO ConsultingSenior Consultant, Regulatory Operations & Technology

Mar. 2008 - Aug. 2019Morgantown West Virginia · RemoteEnergetically partnered with companies to build and promote their Regulatory Operations Department from the ground up or worked to direct and facilitate a leadership presence. Mentored staff and grew existing roles of responsibilities. Developed and streamlined processes from highly complex to routine, improving efficiency and productivity. • Provided skillful cross-functional leadership for complex global fillings and worked purposefully and collaboratively with internal and external functions (eg. systems, processes, portfolio, project management) and acquired companies. Traveled for business 60% of the time domestically and internationally. • Responsible for ensuring RIM data standards processes and management in regulatory systems in lieu of supporting submission archiving activities such as INDs, IND amendments, BLAs, BLA supplements, MAAs, MAA variations and/or CTAs following applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). • Ensured regulatory data is compliant with defined standards, policies, and quality requirements. • Directed and led staff meetings to prepare for Submissions, Daily Business, FDA Annual Reports and Audits.

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