VP/Head of Clinical Operations

Job Title: VP/Head of Clinical Operations

Job Number: 32840

Location: Remote, 

Job Description

In this highly visible role, the focus is to be a strong leader who will mentor and inspire a growing team of global clinical operations professionals based in the US and EU. The Clinical Operations team includes groups focused on trial management, study start-up, clinical systems, trial master files, clinical compliance, and patient recruitment and analytics. Reporting to the Chief Medical Officer, you will provide strong visionary leadership for global clinical trial activities and be accountable for the resourcing, development, training, and management of the companies clinical operations team. You will play a key role in successful study execution including rapid enrollment and ensuring trials meet company standards for quality, integrity, and performance standards. In this role you will be part of the Clinical leadership team; your peers will be heads of global teams in medical affairs, clinical development, biometrics, regulatory affairs and PV and safety. This role is responsible for leading clinical operations across all programs in all phases of development  

Responsibilities

• Provide vision and leadership across all facets of Global Clinical Operations
• Continue to build and develop a high performing Clinical Operations team through hiring,
managing, and mentoring of staff
• As a member of the Clinical Leadership Team, represent all aspects of Clinical Operations and
provide updates as required to internal stakeholders
• Work cross functionally on review, planning, and implementation of clinical trials, including
study design, feasibility, regulatory requirements, and logistics
• Write and/or approve operational sections of integrated development plans, study protocols,
investigator brochures, and other regulatory documents
• Provide leadership and direction on clinical projects to ensure the highest standards for
quality and compliance with Company SOPs, ICH-GCP guidelines, GDPR, and other
regulations and patient safety standards
• Establish key performance indicators (KPI) for clinical trial timelines, budgets, etc.
• Oversee the identification of and interaction with KOLs and investigator sites
• Develop standards for selection of CROs and maintain oversight procedures to ensure
effective execution of clinical projects
• Coordinate with other functional areas including biometrics and data management to deliver
high quality trial data deliverables on time and on budget
• Ensure clinical compliance and inspection readiness, in support of potential inspections by
regulatory authorities including FDA, EMA, Health Canada, and others
• As part of the regulatory submissions process, participate in interactions with FDA, EMA,
Health Canada, and other regulatory agencies
• Planning for study start-up activities for new clinical trials

Required Skills

• A minimum of 15-20+ years of clinical trial, pharmaceutical, or biotech-related experience
• B.S. degree is required. Masters, PhD, or PharmD is preferred
• Proven track record building and leading teams (US and global) across multiple clinical
operation functions
• Ability to motivate and lead across all levels in the organization
• Commitment to continuous improvement; seek out new approaches to running a high
performing clinical operations function
• Demonstrated biotech/pharmaceutical industry acumen with the ability to influence senior
leaders and stakeholders on all aspects of clinical operations including clinical study design
and development strategy
Operations/Analytical Skills
• Strong analytical skills with a problem-solving mindset
• Expertise in complex international clinical trial design issues in all phases of clinical
development
• Understanding of Good Clinical Practices and ICH Guidelines and other applicable
international regulations
• Therapeutic experience in rare diseases or CNS conditions and/or experience with global
drug development and NDA filings, experience in developing protocols, SOPs, Clinical Study
Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents