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Senior/ Executive Director, Clinical Operations

Company: Arvinas
Location: New Haven
Posted on: September 12, 2020

Job Description:

Open Positions : Senior/ Executive Director, Clinical Operations Arvinas is a clinical-stage biopharmaceutical company focused on developing new small molecules ? known as PROTAC® (PROteolysis Targeting Chimera) protein degraders ? aimed at degrading disease-causing cellular proteins via proteolysis. Based on innovative research conducted at Yale University by Dr. Craig Crews, Founder and Chief Scientific Advisor, the company is translating natural protein degradation approaches into novel drugs for the treatment of cancer and other diseases. Our proprietary PROTAC®-based drug paradigm induces protein degradation, rather than protein inhibition, using the ubiquitin proteasome system and offers the advantage of potentially targeting “undruggable” as well as “druggable” elements of the proteome. This greatly expands the ability to create drugs for many new, previously unapproachable targets. For more information, visit www.arvinas.com .

Position Summary

Arvinas is seeking an experienced Senior/ Executive 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 Senior/ Executive Director should have experience driving a pre-clinical study into Phase I and through clinical development. The Senior/ Executive 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 Senior/ Executive Director will report to the SVP of Strategic Operations at Arvinas’ headquarters in New Haven, CT.

Primary Responsibilities

Key responsibilities of this role include, but are not limited to:

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

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.

Functional Knowledge and Skills

Experience with Investigational New Drug applications (INDs).

Medical writing experience.

Proficiency with Microsoft Office

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 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.

Effective communication and interpersonal skills; effective interaction with senior management

Flexibility to travel as required

Qualifications

Bachelor’s degree in Life Sciences or Pharmacy. Advanced degree preferred.

15+ years of strong hands-on experience leading clinical trials execution.

Minimum 5 years in supervisory role managing clinical operations staff.

Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness, and financial security of our employees and their families. Benefits include group medical, vision, and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com.

Arvinas is an Equal Opportunity Employer.

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Keywords: Arvinas, New Haven , Senior/ Executive Director, Clinical Operations, Other , New Haven, Connecticut

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