Sr Clinical Trials Manager

Kite Pharma•Parsippany, NJ

20h

About The Position

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA.

Requirements

Excellent interpersonal skills and demonstrated ability to lead is required.
Strong communication and influence skills and ability to create a clear sense of direction is necessary.
Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
Experience in developing RFPs and selection and management of CROs/vendors.
Bachelor's Degree and 6 years experience OR Master's Degree and 4 years experience OR PhD /PharmD

Nice To Haves

Ability to examine functional issues from a broader organizational perspective

Responsibilities

In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
Coaches members of a work team and ensures adherence to established guidelines.
Provides input to program budget and timelines to ensure successful management of all aspects of international clinical trials.
Anticipates obstacles and client difficulties and implements solutions to achieve project goals.
Assists CPM in revising project timelines/budgets as necessary.
Works with management on departmental issues, providing input to clinical operations strategies and work plans.
Communicates with functional peers regarding project status and issues and ensure project team goals are met.
Contributes to development of abstracts, presentations and manuscripts.
Participate in the recruiting and hiring process for CPA/CRAs and support their professional development.
Participate in training of CPAs and CRAs.
Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.
Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.
Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision.
Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.