Principal Scientist, Early Device Program Strategy and Due Diligence

Job Description

Position Description:

Early Device Program Strategy and Due Diligence

The Principal Scientist of Early Device Program Monitoring & Due Diligence will play a pivotal role in leading and coordinating diverse activities between various device and combination product development, discovery, and formulation development teams.

This involves managing a small team of engineers and participating in critical early-phase program direction setting for the delivery device of drug candidates advancing through the pipeline. In addition, this position will participate as device and drug-device combination product SME in due diligence assessments of prospective drug candidates entering from licensing and acquisition channels. The successful candidate will adeptly handle the following key responsibilities:

Team Leadership and Interface Management:

• Manage a small team of engineers to serve as interfaces between the delivery device development team and upstream drug and formulation development teams.

• Construct initial overall development strategies, timelines, and transition plans into fully commissioned Device Working Groups.

• Engage with early-phase and pre-clinical drug development teams, conduct initial device-ability assessments, and perform platform fit/suitability assessments.

• Establish the business case justifying full device development and clear target product profile elements.

• Establish resource plans and monitor lifecycle management opportunities for assets currently in development.

• Evaluate delivery device technology, including freedom to operate (FTO) and intellectual property (IP) considerations in collaboration with the Legal department.

Business Development and Due Diligence:

• Serve on Business Development and Licensing (BD&L) due diligence assessments for assets and acquisition targets under consideration.

• Mentor team members conducting similar due diligence activities.

Collaboration and Partnerships:

• Collaborate effectively with downstream Device Development and Technology groups to ensure efficient and seamless product and knowledge transfer.

• Collaborate with clinical and marketing colleagues to design product profiles for prospective combination product programs, ensuring alignment with the broader product development and commercialization strategies.

Strategic Planning and Execution:

• Provide strategic leadership in the development of medical devices and drug-device combination products, aligning with the company's overall business strategies and goals.

• Drive the development and implementation of strategies for device technology selection, clinical evaluation, early combination product development, and regulatory compliance.

Position Qualifications:

Education Minimum Requirement:

• Bachelor's Degree

Required Experience and Skills:

• Minimum 10 years’ experience working within the drug-device combination product and formulation development areas 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, with a knowledge of the requirements …