Open Positions: Clinical Operations Lead
Arvinas is a clinical-stage biopharmaceutical 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 two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.
Arvinas is seeking an experienced Clinical Operations Lead to oversee the strategy and implementation of all sponsored clinical trials within Arvinas’ development pipeline. The Clinical Operations Lead should have experience driving a pre-clinical study into Phase I and through clinical development. The Clinical Operations Lead 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, they 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 Clinical Operations Lead will report to the Executive Director, Clinical Operations Arvinas’ headquarters in New Haven, CT.
Arvinas is a fast-paced, team based innovative organization creating products to benefit patients’ health. As a member of the Arvinas team you will be challenged to deliver life-changing therapies for patients’ whose lives have been impacted by cancer and other diseases.
This position is based out of our headquarters in New Haven, CT or may be performed remotely from a location within the U.S.
Key responsibilities of this role include, but are not limited to:
- Leads and directs the clinical operations teams responsible for management and execution of all clinical trials in the assigned program(s). This includes but is not limited to, ensuring cost, quality and timeliness of multiple studies is met.
- Responsible for assisting in the creation/maintenance of clinical operation department goals, budget, training matrices, and study priorities.
- Provides operational strategic and technical guidance to ensure that clinical programs 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.
- Supports the building of department infrastructure, training, and retaining the clinical operations team.
- Ensures that external vendors are selected and managed to deliver within established timelines and budget. This also includes site qualification and initiation.
- Supports 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.
- Bachelor’s degree in Life Sciences or Pharmacy. Advanced degree preferred.
- 10+ 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
- Preferred experience with Investigational New Drug applications (INDs).
- Preferred medical writing experience.
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.