We are looking for experienced Clinical Trial Leader and Clinical Opera5ons Manager who will be responsible for all aspects of assigned Hengenix’s clinical trial por>olios compliance with GCP’s, SOPs and ICH standards within established 5melines, standards, and budgets.
• Lead study opera5onal strategy and planning and oversee execu5on of clinical studies for assigned clinical program(s), suppor5ng clinical strategy defined in Clinical Development Plan.
• Manage clinical studies in mul5ple Phases including, but not limited to, the development of study start-up materials, clinical supplies, case report forms, contracts and budgets, inves5gator mee5ngs, and regulatory document filing in conjunc5on with the appropriate func5ons.
• Work with other team members to coordinate prepara5on of study protocols and final study reports when appropriate.

In close collabora5on with Clinical Lead(s)
• Oversee the execu5on of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regula5ons, and company SOPs), on schedule and on budget.
• Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet company's obliga5ons described in ICH-GCP and company's business objec5ves.
More than one study and/or more than one program may be assigned at a 5me
This is an exci5ng opportunity for an individual with demonstrated learning agility to work on mul5ple programs across
mul5ple phases of development in Oncology
A detailed understanding of overall strategic direc5on, interrela5onships and business needs is required.
ACCOUNTABILITIES:
• Accountable for planning and opera5onal strategy and execu5on for assigned clinical trials
○ Provides subject ma[er exper5se and opera5onal input into protocol synopsis, final protocol, and other study related documents
○ Challenges study team to ensure opera5onal feasibility, inclusive of pa5ent and site burden
○ Validates budget and ensures impacts are adequately addressed
○ Par5cipates in country and site feasibility/selec5on process, with a focus on providing country insights, corporate alignment, and therapeu5c exper5se to ensure alignment between study execu5on plan and program strategy
○ Challenges study team to ensure 5melines meet the needs of the clinical development plan
○ Ensure new team members and vendors are appropriately onboarded
• During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Opera5onal Strategy in prepara5on for Opera5onal Strategy Review; focus on ensuring accurate assump5ons are applied and robust risk management plans are in place
• Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly
• Responsible for study budget planning and management and accountable for external spend related to study execu5on. Works closely with Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gai5ng are accurate; Communicates study status, cost and issues; serve as escala5on point for third party vendors and/or other CROs
• Oversee Strategic Partners/CRO/vendor selec5on, budget and contract nego5a5on, and proper supervision of performance for all ac5vi5es assigned to a Strategic Partner/CRO/vendor for assigned studies, including escala5on of issues to governance commi[ees when warranted, if needed;
• Specific areas of sponsor oversight include, but are not limited to:
○ Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and ac5ons related to monitoring
○ Review and endorsement of relevant study plans, as applicable
○ Study team mee5ng management and a[endance when necessary; regular review of mee5ng agendas and minutes
○ Review of outcomes/ac5ons related to protocol devia5ons review; primary purpose of review is to support the iden5fica5on of trends across sites and/or the study
○ Documented review and monitoring of issues, risks and decisions at the study level and implementa5on of appropriate mi5ga5on strategies
○ In partnership with data management, review and pressure test all database 5melines and plans; ensure strong linkage between the strategy (i.e., filing/registra5on, data genera5on, etc.) with the tac5cal plan for database lock and CSR.
○ Ensure studies are “inspec5on ready” at all 5mes; may be involved in regulatory inspec5ons by preparing for and/or a[ending the inspec5ons.
• Confirm adherence to GCP compliance execu5on through all stages of clinical trial conduct including but not limited to: core study execu5on documents, clinical trial sponsor oversight, devia5on management and internal audit support
○ Co-Lead the internal audit/devia5on response process within Clinical Opera5ons and follow response/CAPA commitments to comple5on
○ Co-lead Global Inspec5on Readiness ac5vi5es
○ Partner with clinical teams on risk management/mi5ga5on ac5vi5es
○ Provide Clinical Opera5ons support with noncompliance repor5ng
○ Contribute to Clinical Opera5ons Lessons Learned
○ Develop and report compliance metrics
○ Support and par5cipate in internal audits and regulatory authority inspec5ons as needed
○ Maintain awareness of changes within the industry and regulatory environment (i.e. ICH guidelines) to ensure the organiza5on is aligned
○ Lead and support efforts to increase compliance awareness and a culture of compliance
○ Project Manage process improvement ini5a5ves
• Managing all aspects of study progress from start-up to close-out ac5vi5es and assuring adherence to intended 5melines to achieve study goals while ensuring compliance with interna5onal GCP guidelines/regula5ons and SOPs/SWPs.
○ Coordina5ng interdisciplinary ac5vi5es involving study start-up: inves5gator mee5ng planning, case report form development, study drug supply design and ordering, development of contracts and budgets, data base set-up, regulatory document filing.
○ Preparing and/or reviewing study-related documents (e.g., Study Opera5ons Plan, Monitoring Plan, Laboratory Manual, CRF Comple5on Guidelines, and other study-specific documents or manuals). Preparing/reviewing site study documents (i.e., site-specific informed consent, study tools/worksheets, inves5gator contracts, and site payments).
○ Collabora5ng with the therapeu5c area team and project management to develop strategies and meet goals/5melines set forth by the team.
○ Oversight and management of CRO (when needed) to ensure successful conduct of the clinical trial by managing daily study ac5vi5es to ensure data integrity and quality.
○ Communica5ng with study sites, proac5vely recognizing problem situa5ons, and informing team members to enable issue resolu5on.
○ Contribu5ng to individual and team development through training ini5a5ves and team building ac5vi5es.
Required Knowledge & Experience
• Bachelor’s degree in biological science, nursing, or pharmacy (or equivalent) as a minimum. Advanced degree preferred. 10+ years of relevant experience with a bachelor’s degree; 6+ years of relevant experience with a Master’s degree.
• Minimum 5 years of experience in the pharmaceu5cal industry in a posi5on performing clinical opera5ons func5ons.
• At least 4 years of clinical opera5ons line management experience including managing CRAs
• Experience working on Entry in Human to global studies with vendors involving management of submission 5melines and associated processes.
• Demonstrated experience in the iden5fica5on of emerging risks and the ability to collabora5vely champion solu5ons within a mul5-disciplinary drug development team to help resolve challenges is required.
• Solid project management, analy5cal and problem-solving skills.
• Prior experience with development and tracking of study budgets.
• Project Management experience
• In depth knowledge of interna5onal GCP and ICH regulatory requirements
• Experience with internal audits and CAPA
• Independently lead and manage cross-func5onal ini5a5ves
• Must be a demonstrated self-starter and team player with strong interpersonal skills
• Must have the ability to build and maintain posi5ve rela5onships with management, peers, and subordinates
• Excellent communica5on skills, provide clear and concise instruc5ons
• Nego5ate sensi5ve issues in an objec5ve manner
• Cri5cal and crea5ve thinking to be able to resolve complex problems
• Ability to priori5ze and adjust workload to meet evolving department and regulatory needs
• Lead by example to champion quality and compliance
• 30% travel required
• All other du5es as assigned.
• This posi5on can be remotely based or office based. If Remote, regular visit to main site will be expected