- Lead a clinical development devices team comprised of clinicians and clinical program leaders.
- Provides leadership and support on medical device and combination products programs in areas of clinical development and medical leadership within Medical Devices CoE. Supports development and execution of medical & clinical strategy for medical devices and combination products.
- Assures clinical study design and data generated meets regulatory authority requirements, stakeholder requirements, and quality standards for medical devices and combination products
- Contributes to the clinical study design for medical devices and combination products
- Leads safety review input for medical devices and combination products
- Understands closely device development and execution of clinical program and studies to support novel drug delivery devices and combination products.
- Demonstrates in-depth knowledge of global regulatory/industry rules and guidance s (e.g. ICH, GCP, promotional guidelines and labeling) to drive the strategic approach to medical device approval and clinical trial application process.
- Leads 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.
- Reviews and evaluates resource needs and influence for appropriate prioritization of programs
- Provides input and rationale to influence cross-functional team
- Ensures performance standards are realistically set and attained for internal and external resources
- 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
- Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all 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.
Education & Experience Requirements
- 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
- Availability to travel up to 25% of time.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.