Executive Director, Clinical Operations

Summary

Join Arvinas, a clinical-stage biotechnology company, as their experienced Executive Director of Clinical Operations. You will lead and build a team, overseeing the strategy and execution of all sponsored clinical trials. This role requires driving pre-clinical studies into Phase I and through clinical development, ensuring program objectives are met within timelines and budget. You will work with company leadership to establish necessary infrastructure and quality systems. The position demands adherence to GCP, ICH Guidelines, and Arvinas SOPs, reporting to the Chief Medical Officer. Remote work within the United States is possible. Arvinas offers a competitive compensation and benefits package.

Requirements

• 15 years of combined pharmaceutical and biotech hands-on experience leading clinical trials’ execution
• Minimum 5+ years in supervisory role managing clinical operations staff
• Strong leadership experience with the ability to motivate staff and drive high quality execution
• Experience with Investigational New Drug applications (INDs) and New Drug Applications (NDAs)
• Experience managing a study from pre-clinical to clinical phase through to registration
• Proven ability to build strong relationships with external partners, CROs, and vendors, including extensive experience managing contracts and clinical finance activities
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills, including the ability to support and prioritize multiple projects
• Medical writing experience
• Effective communication and interpersonal skills; effective interaction with senior management
• Proficiency with Microsoft Office
• Flexibility to travel as required
• Arvinas will not be providing VISA sponsorship for this position now or in the future. You must have the ability to work without a need for a current or future VISA sponsorship
• The duties of this role are generally conducted in a home office environment. Employees must be able, with or without an accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours
• Bachelor’s degree in Life Sciences or Pharmacy required

Responsibilities

• Develops, implements, and/or manages adequate systems and procedures to ensure efficient day-to-day operations that meet Arvinas’ clinical trial needs
• Leads and directs the clinical operations team responsible for management and execution of all clinical trials. This includes but is not limited to, ensuring cost, quality and timeliness of multiple programs is met
• Expands Arvinas’ in-house clinical operations capabilities, as needed
• Responsible for creating/maintaining clinical operation department goals, budget, training matrix, and study priorities
• Provides strategic and technical guidance to ensure that clinical trials are properly defined, planned, and executed
• Works in a matrix organization, ensures that study objectives are in line with the clinical development strategy and the overall corporate goals
• Deploys resources, as necessary, for each new project and ensuring that clinical program and trial objectives have been properly communicated to key personnel (e.g., Project Managers, and other functional areas)
• Ensures that external vendors are selected and managed to deliver within established timelines and budget. This also includes site qualification and initiation
• Tracks and collaborates on the management of study budgets and contract negotiations with vendors and clinical trial teams
• Facilitates and tracks payments to vendors and clinical trial investigators
• Manages interactions with vendors and clinical trial investigators to ensure vendors and sites meet clinical, regulatory, and Arvinas business objectives
• Ensures the quality of clinical trial initiation, study execution, conduct and close-out of clinical trial/program
• Coordinates all Clinical Operations activities, resolving trial execution conflicts, and providing status reports as required
• Interfaces with other functional areas to proactively identify and, if possible, resolve issues or delays that could impact timely clinical study completion
• Drives the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines
• Builds collaborative relationships with key stakeholders including Medical, Regulatory Affairs, CMC/Supply Chain, IT, Legal, Finance departments, and project teams as needed to support clinical programs
• Oversees preparation and review of key documents
• Collaborates with KOLs for feedback on study protocols and development plans
• Implements and leads a high-functioning Clinical Operations Team
• Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders

Preferred Qualifications

• Oncology/Neuroscience experience preferred or multi-therapeutic clinical operations experience
• Advanced degree preferred

Benefits

• Group medical, vision and dental coverage
• Group and supplemental life insurance