Associate Director - Clinical Program Manager 8/9/2016

Biotech/Pharma Company Philadelphia, PA

Company
Biotech/Pharma Company
Job Classification
Full Time
Company Ref #
28655409
AJE Ref #
575826632
Location
Philadelphia, PA
Job Type
Regular

JOB DESCRIPTION

APPLY
ASSOCIATE DIRECTOR, CLINICAL PROGRAM MANAGER-PHILADELPHIA, PA

Lead the development and execution of operational strategies for multiple molecules/programs in the company's portfolio:

* Represent Clinical Operations clinical research teams
* Develop program timelines and budgets and manage variance
* Provide strategic, operational input to clinical development plan, and project plans
* Lead direct reports or project team members to ensure effective development, implementation and execution of all clinical trials within agreed timelines, resources and budget
* Develop operational plan for assigned studies
* Identify program risks and develop and implement mitigation strategies for assigned programs
* Define the resourcing and outsourcing strategy for clinical trials
* Work collaboratively, effectively, and efficiently with all internal and external partners and stakeholders

KEY RESPONSIBILITIES:

* Identify, recruit, hire, and develop Clinical Operations team members as well as oversee their work for assigned projects to ensure all department goals, deliverables, and objectives are met
* Manage direct reports including development, coaching, mentoring, performance management, and succession planning
* Ensure that employees are appropriately trained and comply with company and regulatory standards
* Create a positive work environment by encouraging mutual respect, innovation, and accountability
* Resource projects to enable teams to meet deliverables
* Participate in and/or lead working groups and/or initiatives within clinical operations or cross-functionally as needed
* Optimize and continually improve processes
* Create an environment supporting innovation and smart risk to help the department continuously evolve, improve, and excel

REQUIREMENTS:

* Bachelor's degree
* 10+ years' experience of clinical and drug development, including 5+ years of clinical trial management experience2+ years of clinical program management experience
* Must be willing and able to travel within the USA and worldwide 10-25% of time

THESE ITEMS ARE PREFERENCES AND WILL BE GIVEN TOP PRIORITY:

* Master's degree in scientific or healthcare discipline preferred
* Working knowledge of international regulatory and ICH GCP guidelines
* Functional management experience
* Demonstrated understanding, knowledge, and experience of drug development in a complex setting
* Strong analytical and strategic agility skills
* Excellent planning and organizational skills
* High level of initiative and ability to work independently
* Exceptional leadership skills, including motivation and delegation
* Highly effective team player and exceptional interpersonal skills
* Strong financial acumen with experience managing clinical program budgets
* Ability to provide functional management including performance coaching and staff development
* Ability to implement and manage a clinical program (i.e. a series compromising a clinical development plan)
* Ability to drive, encourage and support innovation
* Demonstrated ability to challenge established practices and concepts
* Highly effective verbal and written communication skills in English