Director, Clinical Operations (Oncology)

Planet Pharma
Rockville, MD
Dec 05, 2022
Dec 08, 2022
Full Time
A$ A' "A' ?The Director will be accountable to oversee a team of Clinical Program Managers (CPM) across an Asset or Assets ensuring their clinical programs are delivered to time, cost and quality. They will provide operational expertise and strategic input to the development of the clinical development plans supporting the overall clinical strategy Phase 1-111 and will be accountable for the operational delivery of CPMs and their programs, ensuring all program deliverables and milestones are met with quality and within budget.Responsibilities:Collaborate with cross-functional counterparts to oversee the performance for all activities to deliver programs on time and with quality.Accountable for the operational delivery of CPMs and their programs, ensuring all program deliverable and milestones are met with quality and within budget. Participate in program strategy meetings, contributing the operational strategy of program/studies.Provide direction and support to CPMs for the development of study strategy operational plans including enrolment models and risk management strategy. Ensure consistent approach and process across the portfolio.Review and provide expert clinical operations input into clinical documents related to the drug development process including study synopsis & protocols, clinical study reports, monitoring plans, Communication plans and project plans.Support efforts for the selection and oversight of external service providers, including Contract Research Organizations (CROs) and other vendors as necessary.Review of study protocols and related study documents, as required, for operational execution.Oversight of team's study execution and procedures as required to ensure regulatory compliance of protocol activities. Support Clinical Program budget negotiations and management of Clinical Operations spend related to clinical program execution. Works closely with Global Project Managers, Outsourcing Management, and Finance to ensure on a regular basis that budgets are accurate.Play an active part in CRO selection and review of RFP's when required, ensuring the appropriate CRO is identified and properly vetted. Work with internal and external teams as required, ensuring the programs are initiated and managed in line with company strategy and key clinical and regulatory milestones.Supports and participate in request and review of scope of works, budgets, vendor performance and issue resolution.Identifies and communicates study issues that will impact budget, resources and timelines & provides support/escalation point for study team leads as needed.Ensures documentation prepared internally or by CRO(s) is completed in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies/programs and consistently across the portfolio.Participates and or Leads governance committee with Vendors.Ensure program meets all GCP/ICH Guidelines and is Inspection Ready.Experience & Knowledge:Worked to fully understand and apply the principles of effective clinical project practices, achieving agreed outcomes. Supporting and influencing key stakeholders where required for the successful delivery of projects.Provided a strong clinical operational focus whilst being able to identify program needs and deliver practical, straight-forward, solutions which work first time.Vendor Oversight experience.Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP. Awareness of local country requirements is also required.Demonstrated excellence in project/program management and matrix leadership.Understands and applies the principles of GCP, ICH, GDP and relevant CFRs is required.Creating and maintaining healthy, creative, relationships with study sites and principle investigators; helping to support and influence where required.Experience presenting high level presentations, both orally and in writing using organizational skills to complement this.Ability to work independently.Ensure an enthusiastic and open attitude towards continuous professional development. Salary range 185,000 to 215,000 Compensation within this range will be commensurate with level of experience

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