Senior Director/Director of Due Diligence, Integration & Launch Excellence

Location: USA based

Key Responsibilities

• Own and maintain the business development diligence process to ensure timely and thorough evaluation of opportunities.
• Collaborate with internal stakeholders and external advisors to manage due diligence across regulatory, clinical, CMC, commercial, medical affairs and legal domains.
• Conducts risk management, scenario planning and develops contingency and/or risk mitigation plans.
• Prepare considered recommendations for senior business leaders on how to proceed.
• Develop and manage the stage-gate framework to evaluate and advance M&A and business development opportunities. Own and drive convening cross-functional teams and ensuring alignment and informed decision-making at each stage of asset assessment and integration.
• Monitor progress, risks, and deliverables to support executive-level reporting and governance.
• Facilitate collaboration across Regulatory, Clinical, CMC, Commercial, Medical Affairs, and Supply Chain teams.
• Lead integration planning and execution for acquired or partnered assets.
• Ensure seamless transition from deal closure to operational execution.
• Lead Divestiture of products with external partner(s).
• Lead cross-functional launch readiness for 505(b)(2) pharmaceutical products, providing integrated plans, timelines, and risk mitigation strategies to support successful execution.
• Partner with functional leads to develop high quality, integrated, cross-functional plans aligned with the overall program strategy.
• Establish governance structures, communication protocols, and performance metrics for alliances.
• Monitor contractual obligations, resolve conflicts, and identify opportunities to enhance collaboration.

 

Qualifications

• Bachelor’s degree in life sciences, business, or related field; advanced degree (MBA, PharmD, PhD).

 

Experience and Attributes 

• 8–15 years of experience in Program Management, Corporate development, or Alliance Management.
• Extensive experience in 505(b)(2) business development, regulatory strategy, and product lifecycle management, coupled with a proven ability to execute M&A and licensing transactions within the 505(b)(2) space.
• Strong understanding of drug development, regulatory pathways, and commercialization.
• Proven ability to lead cross-functional teams and deliver complex projects successfully.
• Thrives in dynamic, fast-paced entrepreneurial environments; excels in communication, negotiation, and stakeholder engagement.
• Familiarity with diligence tools, CRM platforms, and project management software
• Strategic thinker with strong analytical and financial modelling capabilities.