Role Overview
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.
Specific 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.
Requirements and personal skills
- Education: Bachelor's degree in Life Sciences or related field; advanced degree (MS, MBA) preferred.
- Languages: Fluent English; additional languages (e.g Spanish) is a plus.
- Experience: 10+ years in pharmaceutical R&D with at least 5 years in project/program management; generics (ANDA) experience strongly preferred.
- Specific Knowledge: Strong understanding of drug development, FDA regulations, ANDA process, and lifecycle management; PMP certification preferred.
- Technical Skills: Proficiency with project management and portfolio tools such as MS Project, Smartsheet, Planisware, and advanced Excel.
- Travel: Travel is required
- Personal Skills: Strong leadership, strategic thinking, financial acumen, communication, stakeholder management, risk management, and ability to manage multiple priorities in a fast-paced environment.
Physical Demands
This job operates in a professional environment. This role routinely uses standard office equipment such as computers, phones, printers, etc.
Travel: Some overnight travel may be needed for this position. There may be occasional local day travel.
Position Type and Expected Hours of Work: This is a full-time position. Days and hours of work are Monday through Friday, 9:00 a.m. to 5 p.m.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee:
- Is required to interact with internal and external contacts independently
- Is regularly required to talk or hear either in person or over a dial tone phone, as well as a mobile phone, when applicable.
- Is often required to stand, walk, bend, lift, or sit.
- Is required to occasionally lift office products and supplies, up to 40 lbs.
- Is desk-based and may be sitting for long periods of time.
- Must regularly use fingers and hands for fine manipulation: typing, writing, using hand-held device (iPad, laptop, cell phone, keyboard, printer)
- Must communicate clearly: phone calls, emails, in-person conversations
- Must possess ability to make sound decisions, process complex information, manage multiple tasks simultaneously, model behavior for other employees, and other cognitive functions.
