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Program Director

REMOTE, NJ 07054

Posted: 10/27/2022 Employment Type: Contract To Hire Job Category: Clinical Development and Operations Job Number: 525639 Is job remote?: Yes Country: United States

Job Description

Summary:
The Program Director, Clinical Development provides execution leadership across all clinical development programs and lifecycle stages. They partner with the program leads to lead cross-matrix Clinical Development Program Teams that are the hub of drug and device development activities, shaping and executing the product development strategies through all phases.

The Program Director, Clinical Development is a seasoned project manager who is accountable for the cross-functional planning and execution of all clinical development programs including definition of the operational strategy, management of timelines, cost, quality, and risk assessment and mitigation. The Program Director provides an independent voice to shape the overall project strategy and drive optimal decisions for the broader portfolio value. They also are champions of the project management role, and support, champion and execute on the Clinical Development strategy and vision to enable an industry-leading project management organization.

Essential Duties & Responsibilities: The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned. • The Program Director is accountable for coordination of cross-functional clinical program teams of moderate or high complexity and is highly autonomous in supporting the clinical portfolio as part of their day-to-day work.
• Partners with the VP Clinical Development to lead a cross-functional Matrix team of experts in advancing programs/assets. Acts as an integrator within the Clinical Development team and across the enterprise to ensure alignment on project strategy implementation in alignment with project priority, across all intended indications and for all geographies.
• Accountable for creating and maintaining a cross-functional development plan, timeline and budget for each program and ensuring progress vs. plan.
• Proactively identifies and facilitates team review of program risks and ensures mitigation plans are developed and implemented.
• Ensures all decisions are assessed as to their risks and impacts. Accountable for communication to team and stakeholders in a transparent and timely manner.
• With the VP Clinical Development, works to foster a high performing team and monitor the health and operating efficiency of the team as a unit. Leads creation of team norms and operating principles with a focus on cross-functional input and accountability, and robust analysis of vetted options and decision making per guidance framework.
• Coaches project team members and others to drive excellence and accountability, and develop talent pipeline for Clinical Development Team membership.
• Ensures appropriate Clinical Development Team membership during the progression of the program.
• Coordinates resource and budget planning across functions to assure adequate resources are applied to the project and any changes are highlighted appropriately.
• Advises on governance expectations and prepares for key decision point discussions with focus on cross-functional input, rigorous debate to enable efficient decision making.
• For projects that are being jointly developed, works closely with a key strategic alliance partner.
• As project management subject matter expert, understands best practices, identifies gaps and challenges, implements efficiencies and improved ways of working corporate strategy teams.
Supervisory Responsibilities: This position may include supervisory responsibilities.

Interaction: The incumbent works closely with employees in all other functional areas and directly with VP Clinical Development.

Education and Experience: • Degree in Life Sciences, Chemical Sciences, Physical sciences or other relevant discipline., MS/Ph.D. preferred.
• Minimum of 7-10 years of experience in biotech/pharmaceutical industry, including 5 years in project/portfolio management or leadership of cross-functional Matrix teams.
• Demonstrated competency in drug development expertise with solid understanding of drug and/or device development pathway with the ability to contribute to strategic discussions.
• Leadership skills including situational leadership, ability to lead a team of experts and influence without authority.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knowledge, Skills, and Abilities: 1. Demonstrated ability to lead Matrix teams, knows how to work at the strategic level with the Clinical Development leads and when to delve deeper to resolve issues and challenges.
2. Experience with commonly used project management tools, eg Microsoft project
3. Strong communicator able to integrate and succinctly summarize the various parts of a project and effectively tailor messages to an audience including senior leaders.
4. Ability to resolve complex problems and manage difficult stakeholder situations.
5. Ability to lead the development of critical path analyses and scenario planning.
6. Excellent Project Management Skills - drives execution while balancing speed, quality, risk and cost.
Physical Demands: The physical demands described here are representative of those that must me met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Typical office setting with a laboratory, offices and cubicles. Employee is located in cubicle or private office. Noise level is moderate with consistent printer, telephone ringing and conversation.
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