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 .
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.
Key responsibilities of this role include, but are not limited
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
Responsible for creating/maintaining clinical operation
department goals, budget, training matrix, and study
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
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
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
Builds collaborative relationships with key stakeholders
including Medical, Regulatory Affairs, CMC/Supply Chain, IT, Legal,
Finance departments, and project teams as needed to support
Oversees preparation and review of key documents.
Collaborates with KOLs for feedback on study protocols and
Implements and leads a high-functioning Clinical Operations
Fosters a highly collaborative culture and serves as a
leadership role model within the company and with external
Functional Knowledge and Skills
Experience with Investigational New Drug applications
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
Effective communication and interpersonal skills; effective
interaction with senior management
Flexibility to travel as required
Bachelor’s degree in Life Sciences or Pharmacy. Advanced degree
15+ years of strong hands-on experience leading clinical trials
Minimum 5 years in supervisory role managing clinical operations
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
Arvinas is an Equal Opportunity Employer.
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Leading the way in targeted
protein degradation therapeutics.