Director, Clinical Operations

Arvinas is seeking an experienced Director of Clinical Operations; this person will lead and build a team of Clinical Operations professionals who will oversee the strategy for implementation and the execution of all sponsored clinical trials within Arvinas’ development pipeline.

The Director should have experience driving a pre-clinical study into Phase I and through clinical development. The Director will also ensure that clinical stage programs achieve program objectives within established timelines, budget and quality standards. Working with the company leadership, the individual will ensure that the appropriate company infrastructure and quality systems are in place to support all clinical trials. In this role, she/he will lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP), International Conference of Harmonization (ICH) Guidelines and Arvinas SOPs. The Director will report to the VP of Development Operations at Arvinas’ headquarters in New Haven, CT.

Key Responsibilities:

  • 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.
  • 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.
  • Working in a matrix organization, ensures that study objectives are in line with the clinical development strategy and the overall corporate goals.
  • Leads and directs the building of department infrastructure, including developing, training, and retaining the clinical operations team; ensures prioritization of activities and resourcing is in line with clinical development programs.
  • Ensures that external vendors are selected and managed to deliver within established timelines and budget. This also includes site qualification and initiation.
  • 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.
  • Collaborate with KOLs for feedback on study protocols and development plans.
  • Implement and lead a Clinical Development Team
  • Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders.

Qualifications:

  • Bachelor’s degree in Life Sciences or Pharmacy. Advanced degree preferred.
  • 12+ years of strong hands-on experience leading clinical trials execution.
  • Minimum 5 years in supervisory role managing clinical operations staff.
  • Ability to take a leadership role, motivate staff, and drive high quality execution.
  • Oncology/rare disease experience preferred or multi-therapeutic clinical operations experience
  • Experience managing a study from pre-clinical to clinical phase.
  • 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.
  • Effective communication and interpersonal skills; effective interaction with senior management
  • Flexibility to travel as required

Special Knowledge Preferred:

  • Experience with Investigational New Drug applications (INDs).
  • Medical writing experience.
  • Proficiency with Microsoft Office SystemsArvinas is seeking an experienced Director of Clinical Operations; this person will lead and build a team of Clinical Operations professionals who will oversee the strategy for implementation and the execution of all sponsored clinical trials within Arvinas’ development pipeline.The Director should have experience driving a pre-clinical study into Phase I and through clinical development. The Director will also ensure that clinical stage programs achieve program objectives within established timelines, budget and quality standards. Working with the company leadership, the individual will ensure that the appropriate company infrastructure and quality systems are in place to support all clinical trials. In this role, she/he will lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP), International Conference of Harmonization (ICH) Guidelines and Arvinas SOPs. The Director will report to the VP of Development Operations at Arvinas’ headquarters in New Haven, CT.

Location

New Haven, CT

Please send CV and cover letter to: careers@arvinas.com.