Senior Medical Research Manager
Senior Manager, Medical Research
Department: Clinical / Development
Location: Cambridge, MA
Pay rate:
Position Overview
The Senior Manager, Medical Research – IIS & Research Collaborations plays a pivotal role in advancing externally sponsored research initiatives. In this position, you will lead the operational execution and oversight of Investigator‑Initiated Studies (IIS) and Research Collaborations (RC), partnering closely with cross‑functional teams to ensure efficient, compliant, and high‑quality study execution.
You will act as the central point of contact for investigators, internal stakeholders, and vendors—making this an excellent opportunity for a detail‑oriented, relationship‑driven scientific operations professional who thrives in a fast‑paced, global environment.
Key Responsibilities
Program Leadership & Oversight
• Serve as the primary point of contact for IIS and RC activities across regions
• Manage communications and relationships with investigators, academic partners, and internal teams
• Oversee the full lifecycle of externally sponsored research, including:
• Concept intake
• Review and approval
• Budget evaluation
• Contracting
• Study execution
• Close‑out
Governance & Documentation
• Coordinate Medical Affairs Review Board (MARB) meetings, including agenda creation, document preparation, and minutes
• Track IIS/RC metrics and provide regular updates to Medical Affairs leadership
• Ensure inspection readiness through complete, accurate, and easily retrievable documentation
• Partner with safety and quality teams to support audits and inspections
Vendor & System Management
• Provide oversight and collaborate with the IIS portal vendor on system issues and updates
• Ensure drug shipment activities comply with regional requirements and internal quality standards
Budget & Operational Excellence
• Manage IIS and RC budgets, including annual planning
• Identify operational challenges and propose practical, scalable solutions
• Contribute to initiatives that enhance investigator experience and streamline internal processes
Leadership & Values
• Model organizational core values in all interactions and deliverables
• Foster strong cross‑functional relationships to support program success
Qualifications
Required
• BA/BS in Life Sciences or related field
• Proven experience in the pharmaceutical or biotechnology industry
• Prior experience in Clinical Operations and/or Medical Affairs supporting GCP/GPP studies
• Strong working knowledge of:
• ICH/GCP
• Regulatory guidelines and directives
• Drug development and clinical research processes
• Excellent verbal and written communication skills
• Strong relationship‑building and stakeholder management abilities
• Highly organized, detail‑oriented, and able to work independently
• Solution‑oriented mindset with strong problem‑solving skills
Preferred
• Advanced degree or professional certification
• Experience managing externally sponsored research (IIS/RC)
Apply Now
Apply Now
Department: Clinical / Development
Location: Cambridge, MA
Pay rate:
Position Overview
The Senior Manager, Medical Research – IIS & Research Collaborations plays a pivotal role in advancing externally sponsored research initiatives. In this position, you will lead the operational execution and oversight of Investigator‑Initiated Studies (IIS) and Research Collaborations (RC), partnering closely with cross‑functional teams to ensure efficient, compliant, and high‑quality study execution.
You will act as the central point of contact for investigators, internal stakeholders, and vendors—making this an excellent opportunity for a detail‑oriented, relationship‑driven scientific operations professional who thrives in a fast‑paced, global environment.
Key Responsibilities
Program Leadership & Oversight
• Serve as the primary point of contact for IIS and RC activities across regions
• Manage communications and relationships with investigators, academic partners, and internal teams
• Oversee the full lifecycle of externally sponsored research, including:
• Concept intake
• Review and approval
• Budget evaluation
• Contracting
• Study execution
• Close‑out
Governance & Documentation
• Coordinate Medical Affairs Review Board (MARB) meetings, including agenda creation, document preparation, and minutes
• Track IIS/RC metrics and provide regular updates to Medical Affairs leadership
• Ensure inspection readiness through complete, accurate, and easily retrievable documentation
• Partner with safety and quality teams to support audits and inspections
Vendor & System Management
• Provide oversight and collaborate with the IIS portal vendor on system issues and updates
• Ensure drug shipment activities comply with regional requirements and internal quality standards
Budget & Operational Excellence
• Manage IIS and RC budgets, including annual planning
• Identify operational challenges and propose practical, scalable solutions
• Contribute to initiatives that enhance investigator experience and streamline internal processes
Leadership & Values
• Model organizational core values in all interactions and deliverables
• Foster strong cross‑functional relationships to support program success
Qualifications
Required
• BA/BS in Life Sciences or related field
• Proven experience in the pharmaceutical or biotechnology industry
• Prior experience in Clinical Operations and/or Medical Affairs supporting GCP/GPP studies
• Strong working knowledge of:
• ICH/GCP
• Regulatory guidelines and directives
• Drug development and clinical research processes
• Excellent verbal and written communication skills
• Strong relationship‑building and stakeholder management abilities
• Highly organized, detail‑oriented, and able to work independently
• Solution‑oriented mindset with strong problem‑solving skills
Preferred
• Advanced degree or professional certification
• Experience managing externally sponsored research (IIS/RC)
Apply Now
Apply Now