Manager, Medical Research

Alnylam Pharmaceuticals • Cambridge, MA

23h • Hybrid

About The Position

The Manager, Medical Research is responsible for managing and coordinating operational activities for medical affairs studies including global observational studies, local/regional studies, disease registries and externally sponsored research, such as investigator-initiated studies (IIS) and research collaborations (RC). The role will support the executing ongoing and future studies and the successful implementation and management of the operational aspects of these programs.

Requirements

• BA/BS in life sciences or equivalent. Advanced degree or certification a plus.
• Proven experience in the pharmaceutical/biotech industry, experience in managing investigator-initiated studies, Clinical Operations and/or Medical Affairs managing GCP/GPP studies.
• Knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
• Prior CRO oversight experience is highly preferred
• Must be able to actively manage and track many complex projects in parallel, managing the actions of many people toward shared outcomes
• Strong project management and communication skills
• Strong team player that has a customer service approach and is solution oriented
• Attention to detail and the ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors
• Clear alignment with Alnylam Core Values

Responsibilities

• Provide organizational and project support by working directly with cross-functional individuals and teams to coordinate and execute activities related to key medical affairs studies
• Effectively and efficiently interact with internal, clinical site, and vendor personnel to track activities and milestones related to the conduct of medical affairs studies
• Work as part of an internal team to coordinate to the development of program-specific plans and materials, e.g. informed consent forms, CRFs, study plans, training materials
• Oversee and provide operational support for company-sponsored observational studies by collaborating closely with the CRO to ensure successful execution and compliance with regulatory requirements.
• Develops and maintains the relationship with the CRO and/or other vendors to effectively execute the assigned responsibilities
• Manage communications and serve as the point of contact for the Alnylam Investigator Initiated Studies and Research Collaborations
• Manage the end-to-end lifecycle of IIS and RC, including concept review, contracting, monitor study milestones, and close-out
• Coordinate the Medical Affairs Review Board (MARB) meetings, including preparation of all applicable documentation, including meeting agendas and minutes
• Maintain IIS and RC metrics and report updates to Medical Affairs leadership on a regular basis
• Ensure inspection readiness through complete, accurate and readily available documentation
• Partner with Alnylam GPSRM and QA to support audits and inspections
• Provide oversight and collaborate with IIS/RC portal vendor on issues and updates
• Management of IIS and RC budgets, fair market value analysis, contract execution and milestone payments
• Accountable for ensuring drug shipment activities comply with local/regional requirements and Alnylam quality standards
• Work with legal and compliance to support organization and maintenance of standard operating procedures
• Demonstrate problem-solving skills, including the proactive identification of issues and proposed solutions, in consultation with more senior team members

Benefits

• comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks
• We also offer generous family resources and leave

What This Job Offers

• Job Type: Full-time
• Career Level: Manager