【1400～2000万円】Project leader

【求人No NJB2341232】
担当プロジェクトの臨床データに関する科学的議論や成果物の作成を担います。
グローバルメンバーや国内の治験責任医師と密に連携し、試験設計から結果報告、臨床データパッケージの作成まで幅広く対応。規制申請に必要な臨床試験の計画・実施・完了を主導し、規制当局との調整も行います。
日々の試験管理を監督し、品質やスケジュール、法令遵守を確保。医療専門知識を活かし、治験プロトコル作成や関連文書のレビュー、社内外の関係者と協働しながら臨床開発の成功に貢献します。

■Experience/Knowledge
・Minimum of 10 years of experience in clinical development or related functions within the pharmaceutical biotechnology regulatory authority （e.g. PMDA） or academic research organization setting including experience in leading clinical programs and regulatory submissions （e.g. J NDA）. For candidates with an M.D. degree relevant clinical practice experience may be considered as part of the total required experience.
・Demonstrated experience working in a global cross functional team environment.
・Experience in respiratory （including pulmonary hypertension and interstitial lung disease and bronchiectasis） infectious disease immunology otolaryngology （ENT; including sinusitis） dermatology neurology and/or gene therapy therapeutic areas is preferred.
・Experience in managing development programs and participating in J NDA submissions is preferred.
・Basic understanding of the gene therapy field.
・Strong working knowledge of Good Clinical Practice （GCP） scientific and clinical methodology protocol design project management and regulatory requirements for clinical studies.

■Skills/Capabilities
・Language proficiency:
　Native level fluency in Japanese （reading writing and conversation） is required.
　High level business fluency in English is required.
・Uncompromising ethical standards and professional integrity are essential.
・Highly organized with strong attention to detail clarity accuracy and conciseness.
・Proven ability to work both independently and collaboratively in cross functional teams; demonstrates strong time management skills can perform effectively under pressure and contributes as a proactive team player.
・Demonstrated influence negotiation and conflict resolution skills including the ability to influence effectively with appropriate support from leadership.
・Strong problem solving mindset with the ability to develop creative and practical solutions.
・Excellent verbal and written communication and presentation skills （in both Japanese and English） with the ability to clearly convey ideas and influence others to achieve desired outcomes.
・Demonstrated experience in improving developing and implementing new processes.
・Flexible diplomatic and capable of working effectively in situations of ambiguity.
・Highly proficient in Microsoft Office applications （Word Excel PowerPoint Outlook）.

■Qualification/Certificate
・Master’s degree in Life Sciences Pharmaceutical Sciences or a related discipline is required.
・A doctoral degree （Ph.D. or M.D.） is preferred.

■Others
・Must consistently demonstrate Insmed’s five （5） core corporate competencies: Collaboration Accountability Passion Respect and Integrity along with any other role specific competencies.
・Must demonstrate the ability to interact effectively and collaboratively in a dynamic and culturally diverse environment.
・Non smoker.
・Willingness and ability to travel approximately 20・30% （domestic and international） including overnight travel as required.