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Clinical Trial - Global Study Lead Direct Hire MA
Job ID: 16379 Direct Hire MA
Our client is a mid-sized, public, therapeutics company in the Cambridge area and they are growing! They are seeking an experienced Clinical Trial Global Study Lead (Associate Director level or title commensurate with experience) to plan, budget, initiate and execute one or more large, complex, global clinical studies and implement appropriate standards and processes to ensure clinical study quality.
The main function of this role is to manage and lead the operations of global clinical studies to ensure completion in compliance with applicable GCP/ICH guidelines and regulatory requirements.
Responsibilities include but are not limited to;
• Develop and manage MS Project timeline and the direction, planning and execution of the clinical trials including RFP process and vendor selection.
• Review and approve investigational sites based on complete site assessment by CRO, contracts and budgets negotiations with clinical sites and vendors, and coordination of investigator/study management meetings.
• Maintain oversight of CROs and be responsible for the quality of CRO work through regular review and evaluation throughout the duration of the trial.
• Identify and report potential issues timely and effectively and implement corrective actions. Review and approve CAPA plans at individual site and across studies.
• Participate in internal/external study related audits.
• Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses are developed and executed.
• Reviews critical study documents created by CRO including informed consent forms, study conduct documents such as Study Operations Manual (s), training material, study tools etc.
• Participates in protocol development and review of CSR.
• Works with clinical supplies on study drug quantities and packaging requirements.
• Mentors indirect reports and trains team members/vendors as needed.
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a BA/BS with 7-10 or MA/MS with 5-7 years of direct multi-trial clinical study management experience in biotech/pharma. Must have experience with all stages of clinical study management (start-up, maintenance, close-out) for Phase II/III global studies. Must be able to travel up to 20%, domestically and internationally.
Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with very limited assistance.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.
Sr. Director - Clinical Development (Medical Device) Direct Hire MA
Job ID: 16376 Direct Hire MA
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