Sr. Principal Scientist: Early Program Monitoring & Due Diligence

$164,800 - $259,400/Yr

Merck & Co. - Rahway, NJ

Full-time - Senior

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Senior Principal Scientist of Early Program Monitoring & Due Diligence is responsible for leading and coordinating activities across various teams involved in device development, discovery, and formulation development. This role includes managing a small team of engineers, participating in early-phase program direction, and conducting due diligence assessments for prospective drug candidates. The position requires strategic leadership in the development of medical devices and drug-device combination products, ensuring alignment with the company's business strategies.

Responsibilities

• Manage a small team of engineers to interface between delivery device development and upstream drug and formulation development teams.
• Conduct initial device-ability assessments and perform platform fit/suitability assessments for early-phase and pre-clinical drug candidates.
• Evaluate delivery device technology, including freedom to operate (FTO) and intellectual property (IP) considerations in collaboration with the Legal department.
• Establish the business case for full device development and define clear target product profile (TPP) elements.
• Construct initial overall development strategies, timelines, and transition plans into Device Development Working Groups.
• Establish resource plans and monitor lifecycle management opportunities for assets in development.
• Serve on Business Development and Licensing (BD&L) due diligence assessments for assets and acquisition targets.
• Collaborate with downstream Device Development and Technology groups for efficient product and knowledge transfer.
• Work with clinical and marketing colleagues to design product profiles for prospective drug candidates, ensuring alignment with broader product development strategies.
• Provide strategic leadership in the development of medical devices and drug-device combination products.

Requirements

• Minimum 15 years of experience leading drug-device combination product and/or formulation development within a pharmaceutical or biotechnology company.
• In-depth understanding of early-phase drug development, including formulation science, preclinical and clinical research.
• In-depth knowledge of medical device development, regulatory requirements, and quality standards.
• Proven track record of successfully bringing medical devices and drug-device combination products to market.
• Experience in business development, due diligence assessments, and strategic partnerships in the pharmaceutical or medical device industry.
• Ability to inspire, mentor, and develop a high-performing team.
• Strong communication and interpersonal skills.

Nice-to-haves

• Degree(s) in relevant scientific, engineering, and business disciplines.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days