This is what you will do:

The Director of Evidence and Observational Research (EOR) is a key scientific leadership position within Japan Medical Affairs, responsible for the effective execution of evidence-generation initiatives and research activities that advance Alexion's reputation as an industry-leading organization including real-world evidence.

This role actively develops and maintains close scientific relationships with relevant societies and academies, such as pharmacoepidemiology and Health Economics (HE) societies, to support Alexion's leadership position and foster the introduction of new science and technologies into the team.

The Director is responsible for driving and implementing medical research activities that deliver innovative, value-adding scientific evidence for Alexion products, enabling the best possible outcomes for patients. Specific responsibilities include optimizing the real-world exivence and cost-effectiveness data delivery, expanding data access, applying advanced analytics/technologies, and supporting prospective interventional phase 4 study operations in collaboration with R&D and Commercial functions, maximizing evidence impact across Alexino therapeutic areas.

The Director collaborates with leaders in therapeutic area head, as well as regional and local evidence teams, to strengthen evidence generation capabilities and contribute to the co-creation of innovative evidence.

As a member of the Medical Leadership Team, reporting to the Head of Alexion Medical Affairs, the Director works in partnership with other MALT members and contributes to organizational and people development.

The Director manages and develops the EOR organization, comprising functional groups: Evidence Generation lead, Publication lead, HEOR lead and Data Science lead.

You will be responsible for:

• Develop Evidence Generation powerhouse as the centre of excellence to provide RWE and cost effective evaluation expertise for planning, delivery and communicating Medical Scientific Evidence
• Accountable for the delivery and the management of entire Alexion medical evidence portfolio (Alexion initiated phase 4 studies under GCP, and ESR) across TAs including the business planning, forecasting, and budget control
• Ensure the sufficient Evidence Generation scientific quality and the compliance with Alexion governance/operating procedures and all relevant regulations, codes, laws and guidelines
• Develop and maintain close scientific relationships with relevant scientific societies/academies
• Responsible for the RWE strategy including optimizing the RWE delivery, maximizing data assets, implementing innovative analytics/evolving technologies
• Develop sourcing and partnering strategy for Evidence Generation including the qualification, the contracting, and the establishment of the sustainable/value-adding relationship with the external service providers/partners
• Accountable for bringing cutting-edge digital technologies into the organisation where necessary for brand-new evidence generation approach

You will need to have:

• Advanced degree: PhD, PharmD, or MD is highly desired for A.D., but similar experiences in industry may be acceptable
• 5-10 years of relevant experience in a Pharmaceutical company
• Proven line management/people management experience
• Proven capabilities and passion in coaching, training and developing people/team
• Ability to interpret and organize highly complex scientific data, including experience reviewing clinical trial data and output from statistical analysis programs
• Must be skilled writer with demonstrated ability to review / edit / place scientific articles, abstracts, posters in Japanese. Good language proficiency in English is required
• Working knowledge of current good publication practices and guidelines
• Understanding of the clinical development process, especially clinical study and global health outcomes data.
• Ability to collaborate with medical publications agencies, to plan, write and develop abstracts, posters, oral presentations, manuscripts, slide decks and content for scientific and educational programs
• Experience in working closely with thought leaders and authors
• Demonstrated ability to work independently
• Ability to travel (US and International) as necessary
• Ability to flexibly and respectfully navigate Japanese culture to ensure effective collaboration

We would prefer for you to have:

• Background or prior experience in neurology, hematology, nephrology, immunology, metabolic and/or rare diseases
• Experience in strategic evidence generation planning including database research and publication planning, and related tactical planning and implementation
• Experience with evidence generation and publication management software (e.g., Datavision/iEnvision)

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 Alexion participates in E-Verify.