Job Title: Senior Program ManagerJob DescriptionThe incumbent will lead a team of program management professionals, spearhead key organizational growth efforts, and provide direct program leadership to some of our development programs. The role involves independently managing and coordinating complex drug development activities for cross-functional development projects, including the project management of CMC, clinical, and regulatory activities. Responsibilities include strategy development, project planning, execution, and delivery oversight. The Director will work across research, development, and commercial departments to establish strategy and drive execution of drug development programs. The position also involves managing project budgets, resource plans, and preparing and presenting status and risk management information for top management. Familiarity with a variety of field concepts, particularly in both early and late-stage clinical and regulatory development, is essential. A wide degree of creativity and latitude is expected. This position reports to the CEO.Responsibilities
Lead a team of program management professionals.
Independently manage and coordinate complex drug development activities for cross-functional development projects.
Oversee project management of CMC, clinical, and regulatory activities.
Develop strategies, plan projects, and oversee execution and delivery.
Collaborate with research, development, and commercial departments to establish strategy and drive execution of drug development programs.
Manage project budgets and resource plans.
Prepare and present status and risk management information for top management.
Essential Skills
Minimum of 10-15 years of 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).
Strong motivational and influencing skills.
Comfortable in an agile, matrixed environment.
Effective communication skills across all organizational levels.
Additional Skills & Qualifications
Bachelor’s degree, preferably advanced degree, from an accredited college/university (a degree in life sciences, engineering, or medically related field is strongly preferred).
Project Management Professional (PMP) certification is a plus.
Experience with 505(2)(b) registration pathway is a plus.
Good understanding of the overall drug development process, including pre-clinical, clinical, regulatory development, and commercialization phases.
Demonstrated experience in strategic planning, project execution, control, risk, and resource management for a globally networked organization.
Experience in preparing and presenting reports and/or presentations using tools such as PowerPoint and project dashboards.
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
