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About the Role

Contribute to the TA strategy through researching the medical environment, identifying and building relationships with KEEs, and planning and preparing advisory board meetings. Participate in program meetings to stay updated on progress and provide expert opinions to support team discussions and decision-making.

Responsibilities

• Act as a point of contact for global clinical development experts.
• Review and provide expert input on program-related documents (e.g., protocol, IB).
• Review and/or provide expert input on documents for regulatory interactions (e.g., briefing document for PMDA, Orphan drug designation application).
• Review and provide expert input on relevant parts of filing documents (e.g., CTD, J-PI, RMP).
• Prepare responses to clinical parts of PMDA inquiries in collaboration with JPTL and other JPT members.
• Contribute to discussion of PADG team in collaboration with JPTL and medical affairs.
• Review and expert input on publication strategy and contents/quality of publications.
• Create study documents (e.g., protocol concept sheet) for Japan stand-alone studies.

Requirements

• Minimum of eight (8) years of experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology.
• Experience in Phases 1 to 3 as a clinical scientist.
• Extensive experience as a clinical scientist including KEEs engagement, AdB meetings, preparation of clinical documents (e.g. protocol, IB), regulatory interactions, filing preparation and post-filing inquiry resolution.
• Knowledge of local regulations and guidances.
• English skills that enable communication with global team.

Skills

• KEEs engagement
• Advisory board meetings
• Protocol preparation
• Investigational Brochure (IB) preparation
• Regulatory interactions
• Filing preparation
• Post-filing inquiry resolution
• Clinical scientist expertise
• Medical environment research
• Global clinical development expert communication

Location

• Domestic

Work Type

• Business Trip Available

Experience Level

• Minimum of eight (8) years of experience
• Phases 1 to 3 experience

Education Level

• Life Science related bachelor’s degree

About the Company

• For over three decades, patients and their caregivers have been at the center of everything we do.
• Every day, we are inspired to follow the science and think differently to create better outcomes for them and their families.
• Our mission is driven by understanding who they are as unique individuals, not solely defined by their diseases.
• We’re a leading rare disease company with a diversified projects.
• Our pioneering legacy in rare diseases is rooted in being the first to translate the complex biology of the complement system into transformative medicines over the past three decades.
• Today, we continue to push the boundaries of science and deepen our understanding of rare diseases with patient-centricity at the core.
• This knowledge allows us to innovate and evolve into new areas where needs are unmet and provide an opportunity to help people fully live their best lives.

Equal Opportunity

• 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.