Product Development Program Manager

Product Development Program Manager

Onsite in Warren, NJ

Full-Time

Job Summary:

Responsible for leading and project managing the progress of an assigned portfolio of product development projects (typically 2-3 at any one time). Accountable for developing and executing integrated cross-functional development plans and driving alignment across Clinical, Regulatory, CMC, Manufacturing, Quality, Commercial, and Finance functions. Accountable for the efficient and effective use of company resources towards the successful completion of product development milestones. Requires leadership, tenacity, critical thinking and the ability to build internal and external alliances. Also requires a balance of leadership capabilities, organizational skills, and a hands-on approach to program leadership and execution.

Responsibilities:

• Leads the company to success on an assigned portfolio of product development projects.
• Develops and owns a comprehensive product development plan (including timelines, resource requirements, budget, risks, dependencies, and key milestones) in conjunction with executive management for each assigned product.
• Integrates functional plans into a single cross-functional development plan with clear ownership, dependencies, and accountabilities for key deliverables.
• Identifies project risks and formally measures, communicates and manages the risks and associated mitigation strategies.
• Maintains program-level risk, issue, decision, and dependency tracking and escalates matters requiring management intervention.
• Leads the company Product Development Process (PDP) for all assigned projects ensuring use of checklists, documentation, and appropriate stage gate/milestone reviews are conducted.
• Works on a cross-functional basis to ensure company alignment behind product development timelines and goals (internal development activities, clinical requirements, regulatory requirements, engineering & manufacturing requirements, and commercial & marketing requirements).
• Leads through influence in a matrixed environment while respecting the decision authority and accountability of functional leaders.
• Acts as company's lead representative on external pipeline projects; ensures external pipeline projects are properly managed, resourced, and progressed.
• Facilitates active communication and timely decision-making regarding projects.
• Prepares and presents concise program updates, risks, mitigation plans, and key decisions to senior leadership and applicable governance teams.
• Works with Commercial, Finance, and the Executive Leadership Team to continually assess the return on investment (ROI) for each product.
• Maintains core program management deliverables, including integrated timelines, resource plans, budgets, governance materials, milestone forecasts, decision records, project data, and executive reporting.
• Works as an integral member of the Product Development team to improve the product development process within company.
• Navigates the internal company environment effectively, maintaining flexibility while driving achievement of program goals and timelines.

Qualifications:

• Bachelor's degree in scientific, engineering, healthcare, or business discipline; advanced degree preferred.
• 7 years of experience leading pharmaceutical, biotechnology, or life sciences development programs or projects; the successful candidate must be able to provide a proven track record of project management results.
• Demonstrated ability to build productive relationships with internal stakeholders, external partners, and vendors.
• Strong leadership and cross-functional management skills.
• Demonstrated experience managing integrated timelines, critical paths, resources, budgets, risks, dependencies, milestones, and governance deliverables.
• Working knowledge of the pharmaceutical development lifecycle and the interdependencies among Clinical, Regulatory, CMC, Manufacturing, Quality, and Commercial functions.
• Ability to balance and prioritize a demanding workload and multiple projects/tasks in a fast-paced environment.
• Ability to drive and manage project strategy while focusing on tactical deliverables.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication skills.
• Strong collaborative mindset and ability to lead through influence without direct authority.
• Experience presenting program status, risks, options, and recommendations to senior leadership preferred.
• Experience with project or portfolio management tools required; PMP or comparable program management certification preferred but not required.

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Company reserves the right to make changes to the job description whenever necessary.