Job description
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 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 Executive Director should have experience driving a pre-clinical study into Phase I and through clinical development. The 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 clinical studies in conformance with Good Clinical Practices (GCP), International Conference of Harmonization (ICH) Guidelines, and Arvinas SOPs.
The Executive Director will report to the Chief Medical Officer and can work remotely from a location within the United States.
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 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.
Qualifications
- 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.
- Oncology/Neuroscience experience preferred or multi-therapeutic clinical operations experience.
- 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.
Education
- Bachelor’s degree in Life Sciences or Pharmacy required.
- Advanced degree preferred.
#Linked In - Remote
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
