【Alexion Japan】Associate Director, Japan Program Team Lead

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.

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 eight (8) 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.
• 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.
• Has experience leading preparation of PMDA milestone meetings, such as Pre-IND, EoP-1, EoP-2, Pre-JNDA, focusing on the key strategic issues.
• Has a firm understanding of how to educate/advise/operate with respect to Regulatory Guidances/Internal SOPs/Project best-practice behaviors.

Education

• Bachelor of pharmacology or science and/or higher with a specialty in the assigned therapeutic area, or equivalent experience with clinical development required.

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 upon a 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: Capable to drive performance and delivery of the plans; 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.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.