Job Detail

Job Description

Job summary:

The Associate Director, Medical Research Operations (MRO) provides strategic operational expertise and oversight in the execution of post-drug approval research.  In this role, the successful candidate will act as a strategic operational partner in driving data generation program execution for the Biogen International Region (BIR) and International Partner Markets (IPM) in Asia-Pacific, Latin America, Middle-East, and certain European countries.   The work is performed in close collaboration with the Medical Leadership team for the BIR and IPM regions.

Working across late-stage development and marketed products, the incumbent will manage a team that drives operations for Phase 4 studies, patient registries, outcomes research, and real-world evidence programs. Activities include people management, study planning, start-up, vendor management, site management, tracking and reporting. The successful candidate will also support the Head of Medical Research Operations Study Management in driving process and procedural excellence in the conduct of medical research activities.

The position reports to the Director of MRO Study Management and is part of the Global Medical Operations & Effectiveness function.  Job location is Baar, Switzerland.   Remote work arrangement during the remainder of the COVID pandemic is expected. 

Principal tasks:

• She/he collaborates with BIR Medical Leadership to identify data generation priorities and report on progress


• Communicates with Medical Directors, Medical Science Liaisons, medical managers and external investigators on assessment of scientific relevance and feasibility. Provides feedback for proposal improvement.


• The successful candidate drives data generation programs in close collaboration with the Study Leads:  Responsible for review committee coordination, contracting, study management team formation, publication support, filing, milestones and budget


• Develops registry partnerships in collaboration with BIR Medical Directors. Drives Post-Authorization Safety Study (PASS) activities related to patient registries


• Provides leadership to subordinate staff.  Manages multiple related teams, sets departmental priorities and allocates resources to align with business objectives and annual plan


• Persuades leaders to take action and negotiates with external partners/vendors/customers


• Drives the overall study management strategy for BIR and IPM countries


• Supports the Head of Medical Research Operations Study Management with tracking and update of the medical research project dashboard


• Acts as a key point of contact between Medical Research Operations group and the external research stakeholders and partners


• Liaises with global departments to ensure all current active studies are appropriately tracked and documented in the Medical Affairs Research System


• Coordinates with internal Biogen process, infrastructure, and compliance colleagues to ensure appropriate SOPs related to data generation, analysis, and dissemination are followed

Qualifications

• Minimum of a Bachelor's degree in a health-related field.   Master's degree preferred. 


• Minimum of 12 years of clinical research experience with CRO/Sponsor Project Management responsibility.


• Strong preference for experience with late phase and observational clinical research,Neuroscience or rare disease experience preferred


• You  will possess a track record of successful project management in a life science or healthcare environment. Experience in managing teams is a plus.


• You will have excellent written and verbal communication skills, and  demonstrate potential to continually grow into new responsibilities are needed.


• In addition you are self-motivated and able to work independently, but also recognize when to reach for assistance from other available resources to solve problems. 


• Prior strong Project Management skills including risk assessment and contingency planning


• You are able and used to  manage people distributed across different locations demonstrating a high degree of learning agility


• Critical thinking and operational know-how


• You will have demonstrated success in working independently and show a high level of customer orientation and focus


• You are somebody that is solving problems, and demonstrates excellent troubleshooting abilities


• Languages: Written and verbal English required; additional languages advantageous  

Additional Information

The Associate Director, Medical Research Operations (MRO) provides strategic operational expertise and oversight in the execution of post-drug approval research.  In this role, the successful candidate will act as a strategic operational partner in driving data generation program execution for the Biogen International Region (BIR) and International Partner Markets (IPM) in Asia-Pacific, Latin America, Middle-East, and certain European countries.   The work is performed in close collaboration with the Medical Leadership team for the BIR and IPM regions.

Working across late-stage development and marketed products, the incumbent will manage a team that drives operations for Phase 4 studies, patient registries, outcomes research, and real-world evidence programs. Activities include people management, study planning, start-up, vendor management, site management, tracking and reporting. He/She will also support the Head of Medical Research Operations Study Management in driving process and procedural excellence in the conduct of medical research activities.

The position reports to the Director of MRO Study Management and is part of the Global Medical Operations & Effectiveness function.  Job location is Baar, Switzerland.   Remote work arrangement during the remainder of the COVID pandemic is expected.