Director, Clinical Operations

Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC^® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC^® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins.

In addition to its robust preclinical pipeline of PROTAC protein degraders against validated and “undruggable” targets, the company has three investigational clinical-stage programs currently enrolling: vepdegestrant for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-102 for the treatment of patients with neurodegenerative disorders, and ARV-393 for the treatment of patients with relapsed/refractory non-Hodgkin Lymphoma and potentially other lymphomas.

In April 2024, Arvinas entered into a transaction with Novartis, including a global license agreement for the development and commercialization of the clinical stage PROTAC^® androgen receptor protein degrader ARV-766 for the treatment of prostate cancer. The transaction closed in May 2024.

#TeamArvinas is made up of approximately 280 passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and mission – to improve the lives of patients with serious diseases by pioneering therapies created with our revolutionary PROTAC® protein degradation platform. We’re really excited about the work we’re doing inside and outside of Arvinas, and think you will be, too. But don’t just take our word for it – learn more about life at Arvinas and what employees have to say.

For more information, please visit www.arvinas.com. 

 Position Summary

Arvinas is seeking an experienced Clinical Operations Director to oversee the strategy and implementation 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 Executive Director, Clinical Operations and can work from a remote location within the US.

 Principal Responsibilities

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

• 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.
• Review and Clean Global Clinical Study data.
• Prepare IB and DSUR Documentation.
• Prepare Clinical Documentation.
• Develop protocol paradigm to anticipate protocol execution and preparation of investigators.

Qualifications

• 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 therapeutic area experience required 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.
• Preferred experience with Investigational New Drug applications (INDs).
• Preferred medical writing experience.
• Clinical pharmacology study experience is desirable
• 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 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.

Education 

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

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