Senior Director, New Product & Technology Integration

Role Summary

Senior Director, New Product & Technology Integration. Responsible for managing Technical Operations’ due diligence assessments of new product candidates, coordinating integration planning post-deal, and evaluating new technologies and product concepts relevant to Jazz’s business interests. Leads cross-functional collaboration with Corporate Development, Regulatory CMC, Commercial, Legal, and Finance in a matrix structure.

Responsibilities

• Conduct due diligence in partnership with Corporate Development, maintaining pace, depth of diligence and engagement of internal resources. Provide feedback and strategic direction to improve efficiency of diligence process.
• Direct and oversee (as a matrix manager) diligence programs, coordinating inputs from expert consultants, Technical Operations and other departments as appropriate to the product / stage of diligence.
• Create and maintain assessment documents for each deal candidate, comprising inputs from consultants and Jazz functions with respect to competence/compliance and risk for production technology, CMC approvability and robustness of supply chain.
• Develop and maintain summary CMC assessment covering major milestones for development, major product/process risks and potential mitigations for deal candidates and option programs.
• Develop and maintain knowledge of new pharmaceutical manufacturing technologies & processes as required in line with Jazz business objectives
• As a Matrix manager, plan, oversee and monitor programs to integrate deal products/companies into existing functions and workflows within Technical Operations
• Engage, negotiate with, and maintain effective working relationships with potential/actual partners regardless of size or cultural background.
• Develop and maintain a portfolio of consultants covering a range of technical competencies apropos to due diligence and technology assessment.
• Create checklists, playbooks, templates and other tools to standardize and improve the diligence and integration processes.

Qualifications

• Experience in managing drug substance/drug product process development from Discovery/Phase 1 to post-approval.
• Experience in development of a variety of both large and small molecules and the associated regulatory approval processes and challenges. Knowledge of global requirements highly desirable.
• Proven ability to manage technical assessment outside of specific background, engaging appropriate technical expertise and coordinating functional inputs to achieve desired result.
• Experience with diligence processes at various stages and with various technologies. Experience in integration programs highly desirable.
• Deep technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills with ability to multi-task
• Clear technical writing, including sections of Module 3 and briefing documents for regulatory bodies and excellent oral communication skills are required.
• This position requires proven skills in leadership, project management and working in cross-functional work teams, including sensitivity and adaptability to cultural norms and preferences. Significant experience as a matrix manager is required.
• As a matrix manager, much of the work will be accomplished by mentoring/influencing. Proven flexibility and adeptness in engaging all levels of the organization is a must.

Education

• Bachelors of Science, Master‚Äôs or Ph.D. degree in the fields of Pharmaceutical Sciences, Chemical/Biomedical Engineering, or a related field is required.
• At least 15 years of hands-on experience in drug development and validation, preferably in pharmaceutical or biotech company. This must include experience in program outsourcing and management of CMOs/CROs.
• The ideal candidate will have experience from early feasibility to post-commercialization and one or more areas of deep technical knowledge.

Physical Demands

• Occasional mobility within office environment.
• Routinely sitting for extended periods of time.
• Constantly operating a computer, printer, telephone and other similar office machinery.
• Requirements associated with international and domestic business travel.

Work Environment

• Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
• Frequent computer use at workstation.
• May move from one work location to another occasionally.
• Responsibilities may require a work schedule that may include working outside of ‚Äúnormal‚Äù work hours, in order to meet business demands.
• Periodic business meetings and trade shows requiring appropriate business apparel.