【Alexion Japan】Associate Director, Evidence Generation Lead

This is what you will do:

Evidence Generation Lead manages all evidence generation program such as the Externally Sponsored Research (ESR), Medical Affairs conducting Phase 4 (P4) study Real-world evidence generation, HEOR study and Post marketing surveillance (PMS) etc. through providing operational supports such as facilitating contract, selecting and managing CRO/vender, evaluating FMV, monitoring progress and milestone, challenging new and innovative approaches, and collaborating with other business functionsincluding legal/compliance.  Evidence Generation Lead oversees processes, systems and activities related to evidence generation program from a variety of internal and external sources to ensure data is centrally maintained, managed and available for various stakeholders to access seamlessly in real-time.

You will be responsible for:

• Manage all evidence generation projects conducted by Japan Medical Affairs, including, but not limited to, ESRs, P4 studies, Database research, PMS in all phases through providing operational and technical supports to medical affairs business owner:
  • Before initiation: educate MA staffs on internal and external process, compliance, regulation, basics of life-science research, facilitating TARC, facilitating communication with global counterparts, evaluating feasibility and timeline
  • At initiation of study: facilitate contact, helping milestone design, selection of CRO/vender, determining FMV, helping investigators to manage CRO/ARO
  • During study: Monitor project status and budget, and provide regular report on progress, risks, and recommendations for course corrections if necessary. Monitor milestones and receive outcomes timely as a project manager. Track and facilitate publications
  • End of study: make sure the studies are appropriately and compliantly closed following relevant SOPs in terms of operation, patient safety, milestones and deliverables, contract and payments including pass through
  • Throughout study: Manage day to day study/research operational aspects to ensure Business Continuity across cross functional groups such Legal, Compliance, Finance, Medical and Business Leads.
• Liaise Japan MA TA members who is responsible for successful project progress
• Liaise with internal support functions (e.g. Legal, Purchasing, Compliance, Quality, Accounts Payable) , global support functions (ESR manager) and external vendors to ensure processes are followed.
• Support and maintain the overall study budget (study invoice, Purchase Order PO tracking)
• Ensure transparency over areas of budget responsibility by updating through relevant systems Manage and reconcile Contracts, POs, invoices and Amendments
• Lead and resolve outstanding Invoice/PO issues and communicate in a timely manner to the study sponsor.

You will need to have:

• BS degree in a life science or technology discipline

• 5+ years of experience in pharmaceutical industry or Healthcare
• Good understanding of the medical affairs function in a pharma company
• Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.
  • Project management experience, including cross-functional team and vendor management
• Experience with project budget planning, financial tracking and reporting
• Track record of successful collaborations with both internal and external partners
  • Ability to effectively work with CRO/vendors/Academic Institutions
• Ability to proactively identify and anticipate risks of non-compliance in a complex environment
• Significant user experience with IT systems such as iEnvision, any Clinical Trial Management System and study documentation review systems

• Excellent English language verbal and written communication skills

We would prefer for you to have:

• 2 years+ Experience in Medical Affairs, Medical Operations, clinical development or Real-World Evidence Generation
• Experienced with external contractors/vendors management

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.