Vice President, Clinical Operations Job Description Template
Our company is looking for a Vice President, Clinical Operations to join our team.
Responsibilities:
- Liaise with other functional heads to assure timely and effective implementation of clinical studies;
- Ensure regulatory compliance and adherence to GCP standards;
- Collaborate with functional heads to assure integration of company, project and functional goals towards achieving project milestones and timelines;
- Set strategy for the effective management and resourcing of future clinical trials;
- Identifies and selects high-quality clinical vendors in conjunction with appropriate team members by interviewing and assessing a vendor’s skill set;
- Champions a mindset and approach that fosters collaboration and consistency across Curis;
- Ensures alignment with broader Curis strategic initiatives and business needs;
- Creates a resourcing strategy to support needs for all clinical programs and activities;
- Directly participates in and has accountability for overall clinical operations strategy and performance against key trial metrics;
- Other duties as assigned;
- Prepares and presents trial parameters and clinical information to senior management, vendors, and other key stakeholders;
- Ensures advocacy / voice of the patient represented in the planning, design and conduct of clinical trials;
- Sets overall direction, strategy and performance standards for clinical operations staff to assure that project objectives are achieved;
- Shapes Clinical Development Strategy with Clinical Operations perspectives;
- Creates and oversees execution Clinical Operations Strategy for all programs.
Requirements:
- Must have demonstrated track record of effective management /leadership and building a clinical team;
- 10 – 15 years of operations and research management experience in the pharmaceutical or biotechnology industry;
- Ability to handle multiple tasks to meet deadlines in a dynamic environment;
- Build consensus when possible yet able to make difficult decisions when a consensus cannot be developed or know when to escalate issues;
- “Out of the box” thinker, to take on calculated risks, and champion new ideas and approaches for the advancement of a product portfolio;
- Computer skill should include proficiency with Microsoft Office suite of software;
- Strategic thinker and problem-solver capable of identifying risks and risk mitigation strategies;
- Ability to anticipate and identify core problems, apply insightful analyses and solve problems effectively;
- Excellent written and verbal communication skills;
- Understanding of comprehensive global pharmaceutical regulatory requirements and strategic implications for clinical development operations;
- Extensive experience with vendor oversight and managing external partnerships and relations;
- Global clinical trials/program management experience in oncology;
- Commitment to the highest standards of patient management and clinical research;
- Ability to remain calm and navigate in a fast-paced and ever-changing small company environment;
- Proven ability to lead multifunctional teams and mentor junior staff.