Director, Pharmaceutical Sciences Program Leadership

Role Summary

Director, Pharmaceutical Sciences Program Leadership. Lead development of strategy and plans for complex programs; influence functional/divisional strategy, operations and innovation; mentor staff; contribute to divisional and cross-divisional initiatives. Provide strategic scientific leadership and program management for global CMC development teams; represent CMC in cross-divisional governance; develop department capabilities and standards.

Responsibilities

• Independently lead development of strategy and plans for multiple, complex programs
• Regularly lead and influence functional/divisional strategy, operations and innovation
• Serve as a functional thought leader and mentor
• Contribute to divisional and corporate initiatives and cross-divisional governance
• Provide strategic scientific leadership and program management for global CMC development teams
• Identify, mitigate and communicate project risks to stakeholders
• Lead or participate as a functional expert in divisional initiatives

Qualifications

• Education / Experience: BS + 18 years; MS + 16 years; PhD + 10 years
• Technical Skills/Competencies:
  • Ability to influence development toward a commercially viable product
  • Extensive knowledge of pharmaceutical development, laboratory techniques, process engineering, manufacturing development, statistics
  • Knowledge across allied fields (chemical engineering, analytical/organic/physical chemistry, pharmaceutics, QA/regulatory)
  • Advanced understanding in DMPK, Pharmacology and Toxicology
  • Knowledge of cGMP, ICH Guidelines, regulatory requirements and global submission processes
• Program Leadership Skills/Competencies: Leadership, Risk Management, Communication, Resource Management

Skills

• Propose and influence development to deliver commercially viable products
• Mentor and develop department capabilities; communicate effectively across audiences
• Internal consultancy to Pharmaceutical Sciences; cross-divisional collaboration
• Develop and communicate business cases; ensure technical standards meet industry expectations
• Identify, evaluate, and negotiate novel solutions for project needs

Education

• BS + 18 years, MS + 16 years, or PhD + 10 years of experience