Senior Manager, R&D Project Management

Exeltis & Xiromed•Florham Park, NJ

11d•Onsite

About The Position

We are seeking a strategic and results-driven Senior Manager, R&D Project Management to lead complex and high-value projects within the US generics portfolio. This role is responsible for managing programs from product selection through development and commercial launch, ensuring alignment with company strategy, regulatory requirements, timelines, and financial targets. The Senior Manager will provide leadership across cross-functional teams and drive excellence in portfolio delivery, governance, and financial oversight.

Requirements

Bachelor’s degree in Life Sciences or related field
Fluent English
10+ years in pharmaceutical R&D with at least 5 years in project/program management
Generics (ANDA) experience strongly preferred
Strong understanding of drug development, FDA regulations, ANDA process, and lifecycle management
Proficiency with project management and portfolio tools such as MS Project, Smartsheet, Planisware, and advanced Excel.
Strong leadership, strategic thinking, financial acumen, communication, stakeholder management, risk management, and ability to manage multiple priorities in a fast-paced environment.

Nice To Haves

Advanced degree (MS, MBA) preferred
Additional languages (e.g Spanish) is a plus
PMP certification preferred

Responsibilities

Lead end-to-end management of multiple complex R&D projects across the US generics portfolio from candidate selection through launch.
Define project strategy, scope, timelines, and deliverables aligned with organizational priorities and portfolio goals.
Provide leadership and direction to cross-functional teams including R&D, Regulatory Affairs, Clinical, Manufacturing, Supply Chain, Quality, IP, and Commercial.
Drive governance, decision-making, and escalation of risks, ensuring proactive mitigation strategies are implemented.
Oversee development activities including formulation, analytical development, bioequivalence studies, ANDA submission, and lifecycle management.
Develop, manage, and track project budgets; monitor spend, forecast financials, and identify risks or deviations.
Evaluate project feasibility, business cases, NPV, and commercial potential for pipeline prioritization and selection.
Ensure compliance with FDA requirements and regulatory standards for US market submissions.
Implement and maintain project management tools, dashboards, and reporting systems (e.g., MS Project, Smartsheet, Planisware, BI tools).
Mentor and develop junior project managers; foster a high-performance and collaborative team environment.
Provide regular portfolio and project updates to senior leadership and key stakeholders.
Collaborate with external partners, CROs/CDMOs, and vendors to ensure successful execution.