CAREERS

Director /Sr. Director, Clinical Development Operations

Location: Malvern, PA/ Remote

​

Job Description:

 

The Director Clinical Development Operations will report directly to the Chief Medical Officer working closely with the Head of Clinical Development and be based in Malvern, PA.  The position will oversee the strategic planning, execution, and clinical development deliverables.  A physical presence in the Malvern office will be required at least three days a week when not traveling on Uniquity Bio business.

 

The individual will be responsible for clinical operations support of our product development portfolio and will interact with the cross-functional clinical trial team and partners with internal and external team members (CROs and vendors) ensuring alignment of activities with study projects and timelines.  At times, this position will also provide overall clinical support in collaboration with our Clinical Lead.  Additionally, the individual will serve as sponsor representative for day-to-day monitoring and execution of nonclinical studies with outsourced laboratories and serve as a nonclinical representative on multidisciplinary project teams to support the advanced development of candidate therapeutics.

 

 This position will support Uniquity Bio contracted clinical trial activities and participating investigators and the preparation of clinical trial documents (e.g. protocols, investigator brochures, site operation manuals) ensuring adherence to study timelines, contracts and budgets, quality plans with all applicable regulations and ICH/GCP guidance standards.

 

The compensation for this position will be commensurate with experience and the hiring range is between $235,000 and $275,000.