Alexion Pharmaceuticals

Position Summary

Japan Program Team Lead (JPTL) is responsible for providing strategic and scientific directions on the

assigned therapeutic area in Japan and leading the relivant Japan Program Team(s) managing a single

indication across multiple assets. JPTL represents Alexion in professional interactions with KOLs and the

Japanese health authorities. JPTL consults/supports clinical operational activities from medical perspective.

Typically, a JPTL would conduct their JPT work as part of a GPT and under the supervision of a GPT

Lead/GMT Lead. As the accountable program(s) owner, the JPTL leads and chairs the JPT, leading the

creation of an integrated development/lifecycle management (LCM) plan, maintaining a strategic focus and

ensuring the JPT’s commitments are met.

The JPTL establishes a strong leadership, proactively interacting with and developing partnerships with all

JPT members reporting to GPTL/GMTL, and other stakeholders and consultants both within and outside

R&D. The JPTL should stimulate creative and productive discussions, promote ownership and urgency

(when necessary) as well as robust discussions of risk identification and mitigation opportunities, and

ensure clarity of purpose and responsibilities with the JPT. The JPTL has negotiation and persuasion skills

necessary to ensure success of the program and sets goals for the JPT and specific program-related goals

for the Core Team members.

The JPTL is the “one voice” for the JPT up the line (GPT, Japan R&D Leadership Team, Japan Portfolio

Alignment Meeting and Alexion Management Committee), and is the principal liaison and partner to other

groups.

Principal Responsibilities

The JPTL is accountable for:

• Program ownership in Japan with final accountability for clear definitions of program goals, plans, decisions and deliverables to meet those goals.
• Provides strategic direction and leadership in Japan for assigned programs in accordance with the global strategy. Provides development/LCM strategy and leadership for assigned programs to ensure clear goal setting and robust development/LCM plans for effective and efficient program management.
• Ensures that the JPT implements its plans and adheres to key milestones for assigned programs.
• Accountable for aspects of pre-clinical, CMC, clinical, LCM plans and programs across from initiation of the development in Japan through LCM.
• Leads the JPT and reviews plans for assigned programs.
• Contributes to objective setting and appraisal of core team members for program related activities.
• Keeps APJ senior management informed.
• Is accountable for the program budget.
• Ensures high performance team effectiveness.
• Motivates, educates and collaborates with JPTLs of other therapeutic areas.

Qualifications

• Total leadership experience including project management which includes leadership in more than one CTN, clinical trial management, CSR/CTD creations, J-NDA, PMDA Consultation is desirable.
• Minimum of ten (10) years of experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology.
• Demonstrated experience leading the development of at least one development candidate with adherence to quality, excellence and efficiency.
• Demonstrated experience leading drug development projects and activities in a matrixed, global organization.
• A broad understanding of how to communicate and work well with team members and relevant people as well as scientists and external decision-makers worldwide.
• A thorough understanding of how to influence local and global regulatory, scientific and commercial environments.
• Ability to assimilate data, recognize key variables and analyze complex situations. Make quality judgments.
• Has a realistic expectation of the business, one’s self and others.
• A style which builds alliance within the organization, locally/globally, and/or corporate collaborators.
• Does not confuse effort for results.
• Tenacity to weather short-term setbacks for long-term advantages.
• Broad understanding of the multidisciplinary functions contributing to effective and efficient drug development.
• Solid understand of CMC, pharmacology, toxicology, PK, clinical requirements to support major regulatory filings.
• Has experience leading preparation of PMDA milestone meetings, such as Pre-IND, EoP-1, EoP- 2, Pre-JNDA, focusing on the key strategic issues.
• Excellent understanding of the interdependencies of the various disciplines (e.g., CMC, Pharm/Tox,
• PK, Clinical, Regulatory, Marketing, Finance) – what needs to be evaluated simultaneously vs.sequentially etc. from a strategic planning/risk management time/event/cost point locally and globally.
• Has a firm understanding of how to educate/advise/operate with respect to Regulatory
• Guidances/Internal SOPs/Project best-practice behaviors.

Competencies

• Accountability: Acts with sense of urgency.
• Collaboration: Recognizes and maximizes the contributions of all.
• Decision Quality: Makes good decisions (without considering how much time it takes) based uponna mixture of analysis, wisdom, experience, and judgment.
• Perseverance: Pursues everything with energy, drive, and a need to finish.
• Problem Solving: Can see hidden problems.
• Drive for results: Can be counted on to set ambitious goals and to meet or exceed them successfully
• Motivating Others: Invites input from each person and shares ownership and visibility; Develops, attracts and retains talent of team member.
• Open and positive mindset: Capable to inject optimism, inspires the team through communication and personal examples, and extrovert; Very open to internal stakeholders especially, in a compliant way.

Date Posted

15-4月-2024

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.