Open Positions: Associate Director / 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.
Arvinas is seeking an experienced Associate Director / Director of Clinical Operations; this person will join Clinical Operations and will oversee the startup, operation and the execution of sponsored clinical trials within Arvinas’ development pipeline.
This position reports to Sr. Director Clinical Operations and will be located at our headquarters in New Haven, CT.
Key responsibilities of this role include, but are not limited to:
- A highly functional clinical operations team member responsible for the planning, implementation and execution of assigned clinical trial(s). This includes but is not limited to focus on study milestones and deliverables while ensuring cost, quality and timeliness are met.
- Work in a matrix organization, ensures that study objectives remain in line with the clinical development strategy and the overall corporate goals.
- Ensure that external vendors are selected and managed to deliver within established timelines and budget. This may also includes site qualification and initiation.
- Perform risk management to minimize project risks.
- Responsible for the day to day execution of any/all assigned clinical trial activities in accordance with ICH Guidelines and Good Clinical Practices (GCP) and Arvinas SOPs.
- Work collaboratively 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.
- Foster a highly collaborative culture and manages CRO and other third party relationships that will ensure all clinical trial related tasks are completed within an approved timeline and budget with a clear focus on quality.
- Active participant in all departmental initiatives.
- 10+ years of strong hands-on experience leading clinical trials execution.
- Ability to be prductive and drive high quality execution.
- Oncology/rare disease experience preferred or multi-therapeutic clinical operations experience
- 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 and organization 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
- Experience with Investigational New Drug Applications (INDs) and Clinical Sutudy Reports (CSRs) encouraged.
- Bachelor’s degree in Life Sciences or Pharmacy. Advanced degree is desirable.
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.