Senior Director Clinical Program Management job in Springfield, USA

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First Name*

Last Name*

Email*

Phone Number*

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First Name*

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Job type: Permanent

Discipline: CRA Manager, Project/Study Manager (CSM/CPM), Program Manager / Director

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Senior Director Clinical Program Management in Maryland, Massachusetts, or Toronto. This individual will be responsible for product knowledge and critical thinking to support governance interactions, lead the delivery of a program of studies, and co-ordinate the delivery of the clinical components of Health Authority submissions and documents.

Job Responsibilities:

Effectively partner with the Global Clinical Leader and Global Project Statistician to provide clear direction and agreed on goals
Drive and implement critical initiatives on the program level ensuring the CPT is operating as a high functioning team
Deliver efficient and effective program management of all GPT clinical development deliverables including project strategy, design and delivery of program/studies to time, on budget and with quality
Oversee clinical components of regulatory and related submissions, maintenance support for regulatory interactions and reports, and clinical contributions to inspection readiness.
Lead all clinical operations activities within the program and for ensuring provision of clinical operations expertise/input into the program (e.g. feasibility, country selection, operational input into design, Risk based Quality Management and external partner management)
Act as the initial and program-level AZ operational lead who collaborates with our externally managed/outsourced partners (e.g. CRO/ARO) and collaboration/alliance partners for program planning and delivery
Does all of this sound intriguing to you? If so, we are eager to hear from you!

Skills and Requirements:

Bachelor of Science or equivalent degree
Extensive global drug development leadership or equivalent leadership experience demonstrated in a variety of roles.
Extensive experience across the product life cycle with experience in late stage development.
Comprehensive knowledge of clinical operations and the clinical and pharmaceutical drug development process.
Proven ability to develop programs to meet business goals and to assess business risk versus potential value.
Significant experience of program management and use of project management techniques in complex project including resourcing, financial management and case justification development.
Willingness to travel both domestic and international.
Master of Science / Advanced degree preferred
Demonstrated ability to drive process improvement and/or functional work
Experience of implementing changes in ways of working that focus on increasing efficiency
Regulatory submission experience
Previous success of working in Japan and China to ensure delivery of global programs to meet business needs
Proven experience in leading teams through change
Experience of and insight into the Clinical environment to be able to drive major improvement programs

If you are having difficulty in applying or if you have any questions, please contact Ciara Noble at (+1) 323-518-2700 or c.noble@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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