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Director Program Management

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Actalent

2mo ago

  • Job
    Full-time
    Expert Level
  • Research & Development
    Healthcare

AI generated summary

  • You need 10-15 years in program management in drug development, 5 years as a supervisor, knowledge of all development phases, strong leadership, and effective communication skills.
  • You will lead a program management team, oversee drug development activities, manage project budgets, and coordinate across departments to drive execution and report on project status to top management.

Requirements

  • Minimum of 10-15 years program/project management experience in a generic and/or new drug development environment
  • At least five years of experience as a functional leader/supervisor
  • Broad experience across the product development continuum (product, pre-clinical, clinical, regulatory development, and commercialization)
  • Proficient in program management principles, practices, and tools (PMP certification is a plus)
  • Experience with 505(2)(b) registration pathway
  • Project management of CMC, clinical and regulatory activities
  • New drug development (product, pre-clinical, clinical, regulatory, commercialization)
  • Strong motivational and influencing skills
  • Collaborative and inclusive
  • Comfortable in an agile, matrixed environment
  • Communicates effectively across all layers

Responsibilities

  • The Director, Clinical Program Management will lead a team of program management professionals, key organizational growth efforts, and provide direct program leadership to some of our development programs. Independently manage and coordinate complex drug development activities for cross-functional development projects, including the project management of CMC, clinical and regulatory activities. Manages strategy development, project planning, execution, and delivery oversight. Works across research, development, and commercial departments to establish strategy and drive execution of drug development programs. Manages project budgets, resource plans, prepares and presents status and risk management information for top management. Familiar with a variety of the field's concepts, particularly (both early and late stage) clinical and regulatory development. Relies on experience and judgment to plan and accomplish goals. A wide degree of creativity and latitude is expected. This position will report into the CEO.

FAQs

What is the job title for this position?

The job title is Director, Clinical Program Management (Generics/New Drug Development).

What are the primary responsibilities of the Director of Clinical Program Management?

The Director will lead a team of program management professionals, manage complex drug development activities, oversee project management of CMC, clinical and regulatory activities, and drive execution of drug development programs.

What is the required minimum experience for this position?

A minimum of 10-15 years of program/project management experience in a generic and/or new drug development environment is required.

Is prior leadership experience necessary for this role?

Yes, at least five years of experience as a functional leader or supervisor is required.

What specific knowledge is necessary in drug development?

Candidates should have broad experience across the product development continuum including product, pre-clinical, clinical, regulatory development, and commercialization.

Is a project management certification required?

Proficiency in program management principles, practices, and tools is required, and a PMP certification is a plus but not mandatory.

What is the work schedule like for this position?

This is a hybrid position requiring some days on-site in Bridgewater, New Jersey, and some days remote.

What soft skills are important for this role?

Strong motivational and influencing skills, collaborative and inclusive approach, comfort in an agile, matrixed environment, and effective communication across all levels are important soft skills.

Who will the Director of Clinical Program Management report to?

This position will report directly to the CEO.

What is the company's stance on diversity, equity, and inclusion?

Actalent is committed to diversity and inclusion, focusing on hiring diverse talent, maintaining an inclusive environment, building a culture of care and recognition, and ensuring growth opportunities for all employees.

Is this position permanent or temporary?

This is a permanent position.

How can applicants request accommodations during the application process?

Applicants can request reasonable accommodations by emailing actalentaccommodation@actalentservices.com for other accommodation options.

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Actalent

An Engineering and Sciences Services Company | People to Possible

Human Resources
Industry
5001-10,000
Employees

Mission & Purpose

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent’s global footprint and flexible delivery models ensure access to specialized talent where and when you need it. We promote consultant engagement through professional development and provide experiences to ensure continuous learning. Our people are the difference. Our expertise spans capabilities in engineering including product and manufacturing, systems and software, construction management, environmental, architecture and civil; and power and utilities. We focus on sciences capabilities in laboratory sciences, healthcare, and clinical research. Actalent is an operating company of Allegis Group, the global leader in talent solutions.