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:
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 in 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 team members.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across diverse functional areas and external partners.
- Degree(s) in relevant scientific, engineering, and business discipline.
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