Our Global pharmaceutical client is looking to add a Sr. Director, Clinical Development to their Medical Devices & Combination Products team. This role will lead the clinical development devices team comprised of clinicians and clinical program leaders. Will provide leadership and support on medical device and combination products programs in areas of clinical development and medical leadership within Medical Devices CoE. Sr. Director will support the development and execution of medical & clinical strategy for medical devices, combination products and assure that clinical study design and data generated meets regulatory authority requirements, stakeholder requirements, and quality standards for medical devices and combination products. Will also contribute to the clinical study design for medical devices and combination products and lead safety review input for medical devices and combination products.
- Lead a team of clinical development professionals engaged medical device and combination product development
- Plans strategically, implements and executes medical device programs and work streams
- Works cross functionally to drive the strategy and collaborate to ensure implementation for device clinical programs or company initiatives
- Represents medical devices and combination products perspective in the clinical sub-team of Global Product Teams (GPTs)
- Collaborates with GPT Lead, Global Clinical Development Lead, Medical Director to ensure that all development and product support activities for medical devices are coordinated and consistent
- Provides scientific advice within cross-functional device team leveraging scientific expertise and providing guidance in support of brands and product launches.
- Reviews clinical protocols and clinical study reports for scientific and medical accuracy.
- Participates in drug safety surveillance for development projects.
- Provides expert medical advice / leadership to the project teams on medical devices and combination products for the development of Phase I-IV programs.
- Engage with KOLs and PIs in peer to peer discussions to support clinical trials, advisory boards, and scientific exchange.
- Develops and demonstrates expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
- Demonstrates the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.
- Contributes towards developing target product profiles and play a critical role in crafting the target device profiles.
- Engage with therapeutic area leadership and global clinical development leadership across the organization to integrate medical device and combination product knowledge with drug development knowledge within development process.
- Aligns with team members from other functional areas regarding planning, implementation, tracking, analysis and report of milestones. Participates in due diligence activities
- Participates in Research and Development, department and/or corporate wide task forces as appropriate
- Provides credible company representation in the academic Medical/Scientific Community to facilitate the constructive exchange of positions and ideas.
- M.D. degree At least eight (8) years of experience in the pharmaceutical, device or biotechnology field with relevant industry experience
- Clinical practice experience 3-4 years minimum
- Demonstrated ability to collaborate in a matrixed environment
- Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities
- Experience with the Medical Device Regulation (MDR) and clinical evaluation
- Experience in designing and conducting clinical trials
- Experience with product development and design control in device and combination products