Full-Time Senior Director Clinical Operations
The Senior Director, Clinical Operations must be able to provide both strategic vision and operational guidance to Development Operations and cross-functional teams to develop and execute integrated plans leading to the successful development of new products. This Individual will lead a group of clinical operations staff, with ultimate accountability for oversight and execution of multiple clinical programs and trials. This Role is responsible for translating the overall global product strategy into actionable plans for the Clinical Operations team. The Senior Director will be responsible for all aspects of clinical operations for assigned programs/trials to assure the highest standards of clinical trial execution and GCPs. The Senior Director will support partnerships with contract research organizations (CROs), other Service Providers and clinical Sites involved in the clinical trials and will serve as a functional leader, mentor, and line manager. The Senior Director will serve as a member of the Global Development Operations (GDO) Leadership Team, responsible for contributing to the strategy, vision and direction of the Department. The Senior Director will leverage his/her industry knowledge and significant breadth and depth of experience to proactively generate ideas and independently manage implementation of new tools, technologies and process improvement initiatives to increase the efficiency and effectiveness of Mallinckrodt’s clinical trial execution. The Senior Director may also be responsible for independently leading a functional area within Global Development Operations (e.g., Clinical Supply Management, Supplier Relationship Management or Business Operations) and setting a vision and strategy for that Group. This Leader must possess sufficient Industry knowledge and Development experience to be able to represent GDO on Due Diligence evaluations.
Ensure operational activities and tactical execution are linked to Program strategy.
Independently coordinate the forecasting, planning, execution and reporting of clinical development programs.
Implement strategies and tactics to proactively identify, monitor and resolve project and program risks. Collaborate with cross-functional teams and senior management to resolve complex issues promptly and effectively.
Provide a continuously updated and balanced appraisal of the project and program status, including risk, cost, and value to stakeholders and senior management. Evaluate, highlight, and escalate unresolved issues, potential barriers to program progression and resource constraints.
Establish key performance indicators and metrics for the Global Development Operations department and use Change Management skills to ensure they are translated into Department standards.
Ensure robust Sponsor oversight of Service Providers and compliance with FDA regulations, GCP, ICH, and Company SOPs for all clinical operations activities.
Serve as a member of the Global Development Operations Leadership Team, working in partnership with peers and the VP, Global Development Operations to set the strategy and direction for the department.
When needed, serve as the delegate for the VP, Global Development Operations at strategic meetings. Serve as Signatory coverage, assuming the VP’s Grant of Authority for signing contracts and Agreements.
Support business planning as needed, including demand and resource management. Set appropriate and rational headcount/manpower forecasts to support the portfolio of clinical trials.
Support annual Strategic Planning exercise as needed, including setting internal (OPEX) and external (clinical trial) budget forecasts.
Participate in prioritization exercises to rationalize the clinical projects and non-project initiatives managed on an annual basis.
Serve as the Global Development Operations representative at Project Team/Brand Team meetings to interrogate the operational feasibility of clinical development program designs and decisions.
Collaboratively work with other Functional Areas, as well as cross-functional teams to ensure timely delivery of project deliverables with consistent high performance and quality of work.
Approve and provide oversight of study-specific Clinical Study Plans and contribute to the initial and ongoing risk mitigation/management for clinical trials.
Lead the development and optimization of processes for Clinical Operations. Proactively assess and evaluate the need for new/updated processes and manage implementation of process improvement initiatives.
Provide input into strategies for outsourcing partnerships. Participate in the vendor selection and review process. Lead vendor and Site contracting and manage change order processes as needed.
Strong vendor management to hold Service Providers accountable for performance. Serve as the primary Sponsor representative on Sponsor/Service Provider Operational Governance Committees.
Ensure management of clinical study budgets and specifications so that project/study goals are achieved within scope. Assure study priorities are satisfied and budgets are adhered to. Ensure tracking, financial and resourcing tools are effectively utilized. Support identification and resolution of budget and resourcing issues.
Provide support and oversight to maintain and ensure the quality and completeness of study TMFs in compliance with GCP.
Participate in the development of training programs and manage training initiatives for direct reports. Collaborate with training resources. Document requirements and report completion.
Responsible for objective setting and performance review for direct reports. Identify and address performance issues and training needs at a functional and departmental level. Serve as a resource and mentor to direct reports and other less experienced staff. In partnership with Talent Acquisition, manage recruitment of top talent and make hiring recommendations.
Independently lead non-project initiatives and/or the onboarding of new tools/technologies meant to improve operational efficiency.
Serve as Development Operations’ representative for audits and inspections and lead the effort to respond to findings and close out relevant CAPAs.
Serve as Development Operations’ representative on Due Diligences.
Deliver clinical trial updates/presentations to senior management.
Perform administrative functions and additional tasks as requested.
Department specific/Non-essential responsibilities:
Other duties as assigned with or without accommodation.
Experience / Skills:
Minimum of a BSN/RN/BA or BS in a related field. MBA or advanced degree in a scientific discipline is desirable.
12+ years of progressive R&D Clinical Operations experience at a biotech, pharmaceutical company or clinical CRO; 8+ years leading teams; 5+ years in a Leadership/Strategic role.
Phase 1-4 clinical trial experience required. Experience running pivotal, multi-regional/global clinical trials. Experience leading project operational teams through all stages of the trial (forecasting/planning, start-up, conduct, close-out). Previous monitoring, study coordination, data management and/or clinical project management experience, including vendor/CRO management is required.
Experience managing rare disease, critical care studies is desirable.
A good understanding of Data Management and Clinical Study Report writing.
Previous supervisory/line management experience.
Strong knowledge of the end-to-end pharmaceutical drug development and commercialization process, including hands-on experience in the successful planning and execution or contribution to complex Health Authority interactions such as End-Of-Phase 2, Advisory Committee meetings, IND, sNDA/NDA/BLA submissions and approvals.
Project management and organizational skills. Experience in the use and understanding of the critical value of technology in managing milestones, resource planning and integrating interdependencies within an organization. MS project experience and/or PMP certification a plus.
Scientifically and clinically astute with learning agility, translating to a demonstrated ability to develop a deep understanding of therapeutic areas and optimal development strategies.
Advanced knowledge of cGCP, ICH, FDA and EMEA regulatory requirements.
Ability to motivate and develop staff.
Must have strong prioritization skills and the ability to manage multiple competing priorities simultaneously.
Ability to manage deadlines.
Strong project management, analytical and problem-solving skills.
Proven leadership skills including the capability to rally stakeholders and their resources around the unit’s and company’s goals.
Ability to motivate and drive decision-making within a cross-functional and cross-cultural, global team structure.
Must possess a combination of strategic perspective / critical thinking, managerial courage and proven effectiveness within complex business structures. Track-record of driving difficult decisions to conclusion. Ability to lead and influence various teams without authority.
Ability to work in a virtual setting/across time-zones and make effective use of communication tools (WebEx and video conferencing).
Ability to listen effectively and the capability to effectively communicate ideas and data both verbally and in writing in a persuasive and appropriate manner to a broad array of stakeholders.
Self-driven individual able to function with minimal supervision.
Proficient with MS Office products and other technology tools.
Travel approximately: ~10-20% to resolve field issues and meet with Service Providers.
How to ApplyIf interested and qualified, please visit the link below to apply: https://mallinckrodt.wd5.myworkdayjobs.com/MallinckrodtCareers/job/US-Specialty-Brand-Headquarters---USA501/Senior-Director-Clinical-Operations_JR000010090
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