Exec Dir Clin Ops Leader (DG)

NY/NJ area, NJ - Pharmaceutical & Biotech - Hybrid

Date Posted: 1/23/2023 2:08:55 PM

Executive Director Clinical Operations Leader

Position will be onsite 2-3 days/NY/NJ area
Onsite, BR or TT, This is a replacement role and reports to a VP.
Salary: $300k base, bonus is 30% stock at 100k value

Responsible for leadership and overall strategic management of General Medicines in Clinical Trial Management (CTM). The Executive Director TA Operations Leader will direct clinical operations activities and decisions including quality, timelines and costs related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOP’s) within General Medicines/Late Development (s). The Executive Director TA Operations Leader will take a leadership role in strategy and direction for Clinical Trial Management (CTM) and Development Operations & Project Management (DOPM). This role will report to the Head of CTM and will interface and partner with senior level management across the TA and functions to enable efficient delivery of the assigned TA. Provides sponsorship, leadership, and direction for departmental initiatives. This role holds line management of staff including recruitment, retention, professional development, and performance management.

Partners with the Therapeutic Area Head & Global Program Head, meets regularly to review TA progress and project status. Responsible and accountable for the successful operational delivery of all studies in the TA within the Clinical Development Plan (CDP). Contributes functional area expertise to the development of the program and clinical trial operational strategy (e.g., feasibility, timelines, cost estimates) and participates actively at strategy committees (e.g. Development Program Review and Protocol Review). Ensures delivery of quality operational results while ensuring consistency of process and approaches across clinical programs within and across TAs and facilitates streamlined processes across CTM TA Operations leadership. Identifies and implements opportunities for innovation within clinical trial operations and identifies trends or competitors in disease area landscape to guide operational strategy. Works closely with the Therapeutic Area Head (TAH), Development Portfolio Management (DPM) and Strategic Program Direction to ensure clinical study results support clinical program goals and project execution. Responsible for a consolidated analysis of Key Performance Indicators (KPI) and operational metrics within the assigned TA and developing/leading appropriate action plans. Responsible for providing input into risk management strategy for clinical study teams and ensuring execution against the risk management plan. Responsible to coordinate CRO partnership related to delivery of outsourced services, including ensuring that CTM staff provide an appropriate and documented level of oversight for site/CRO/vendor services. Actively participates in appropriate governance meetings and acts as representative for CTM in CRO Joint Oversight Committees. Works with senior management to report on landmarks including Clinical Operations Review Meetings. Collaborate closely with GCP Quality to ensure Quality Leads and study teams/QC are collaborating on inspection readiness. Responsible for CTM resource forecasting and resource allocation for the clinical studies across assigned TA (s) and overall for CTM. Provides leadership and mentoring to build a successful team, ensuring recruitment, performance management & development of team/staff line management. Contributes to defining and implementing TA goals and objectives aligned to broader departmental & organizational strategies. Leads & coordinates development & maintenance of global standards for clinical trial management, including Standard Operating Procedures (SOP), templates & tools necessary to ensure timely, efficient & high-quality, inspection-ready deliverables. Participates & guides CTM staff through Agency inspections & audits. Initiates & provides leadership in organizational or enterprise/company-wide initiatives. May require up to 25% travel.

Bachelor's degree required, Advanced degree desirable. 15+ years of experience of clinical operations experiences in a pharmaceutical or biotech setting. 10+ years of functional leadership. 10+ years people management, leadership and mentoring experience. 5+ years of leading sophisticated, global clinical trials with outsourced CRO/FSP model(s). In depth knowledge of GCP and ICH, drug development process, and other relevant guidelines for clinical research activities. Experience leading global clinical research activities, General Medicine/Late Development preferred. Exceptional project management, cross-functional team leadership and organizational skills. Ability to make decisions, set priorities, and share resources based upon an enterprise approach, ensuring the benefit to the whole organization. Ability to use network to understand the big picture, perspectives, and expertise to increase performance. Ability to provide strategic direction, guidance, & timely decision-making for program teams; ability to capitalize on opportunities & handle risk. Ability to anticipate & react to new trends in a competitive landscape & therapeutic areas to guide the organizational strategy. Strong analytical skills with a data driven approach to planning, implementing, and problem solving. Proactive/self-disciplined, ability to meet deadlines, effective use of time, & prioritization. Accomplished influencing/negotiation skills. Strong financial foresight in regards to program & study budget management. Ability to generate and inspire trust of others, lead with integrity.

Please contact Darren Gutowski at dgutowski@clarkdavis.com


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