We are seeking an experienced and strategic Senior Manager, R&D Project Management to lead complex development programs within our U.S. Generics portfolio. This individual will be responsible for driving projects from product selection and development through regulatory approval and commercial launch, ensuring alignment with corporate objectives, regulatory requirements, timelines, and financial goals. The ideal candidate is a strong leader with deep pharmaceutical development experience, exceptional project management capabilities, and a proven track record of delivering high-impact programs in a cross-functional environment.
- Salary $150,000 - $160,000
- Onsite 2 days/week
Responsibilities: - Lead the end-to-end execution of multiple complex R&D projects within the U.S. Generics portfolio, from candidate evaluation through commercial launch.
- Develop and manage comprehensive project plans, including scope, milestones, timelines, resource requirements, budgets, and risk mitigation strategies.
- Partner with cross-functional stakeholders across R&D, Regulatory Affairs, Clinical Operations, Manufacturing, Supply Chain, Quality, Intellectual Property, and Commercial functions to ensure successful project execution.
- Facilitate project governance processes, drive decision-making, and proactively identify, escalate, and mitigate project risks and obstacles.
- Oversee key development activities, including formulation and analytical development, bioequivalence studies, ANDA preparation and submission, and post-approval lifecycle management.
- Manage project financials, including budget planning, spending oversight, forecasting, and variance analysis.
- Support portfolio strategy by evaluating project feasibility, business cases, net present value (NPV), and commercial opportunities to inform pipeline prioritization and investment decisions.
- Ensure compliance with FDA regulations and industry standards governing the development and submission of generic pharmaceutical products.
- Utilize and enhance project management systems, dashboards, and reporting tools, including MS Project, Smartsheet, Planisware, and business intelligence platforms.
- Mentor and support the development of project management team members while fostering a collaborative, results-oriented culture.
- Provide clear, concise, and actionable portfolio and project updates to senior leadership and executive stakeholders.
- Collaborate with external partners, CROs, CDMOs, and vendors to ensure project objectives are achieved on schedule and within budget.
Required Qualifications: Education - Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Engineering, or a related scientific discipline required.
- Advanced degree (M.S., MBA, PharmD, or equivalent) preferred.
Experience - Minimum of 10 years of experience within pharmaceutical research and development.
- At least 5 years of project or program management experience in the pharmaceutical industry.
- Demonstrated experience managing generic pharmaceutical development programs, including ANDA submissions, strongly preferred.
Knowledge & Skills - Strong understanding of pharmaceutical product development, FDA regulations, the ANDA process, and product lifecycle management.
- Proven leadership and stakeholder management skills, with the ability to influence and drive results across cross-functional teams.
- Strong financial acumen, including budgeting, forecasting, and business case analysis.
- Experience assessing project viability, portfolio optimization, and commercial opportunities.
- PMP certification is preferred.
- Proficiency with project and portfolio management tools such as MS Project, Smartsheet, Planisware, and advanced Microsoft Excel.
Language Requirements - Fluency in English required.
- Additional language proficiency, particularly Spanish, is a plus.
Personal Attributes - Strategic thinker with strong business judgment.
- Exceptional communication and presentation skills.
- Highly organized with the ability to manage multiple priorities and competing deadlines.
- Strong problem-solving, risk management, and decision-making capabilities.
- Collaborative leader with a demonstrated ability to build high-performing teams and foster cross-functional partnerships.
Travel Requirements - Travel is required for this position.
- Some overnight travel may be necessary, along with occasional local day travel.
