【仕事内容】
■細胞製品の臨床開発やプロジェクトマネジメント業務を担当していただきます。
具体的には:
・細胞製品のライフサイクルにおいて研究・開発・共同研究・承認申請・市販後維持等におけるタイムライン調整、渉外交渉などのプロジェクト管理
※必要に応じて外部コンサルタントとの交渉や管理有り
募集経緯:
iPS細胞を利用した生殖補助医療の開発に取り組む同社は、現在はiPS細胞から卵巣内細胞を分化誘導する技術を用いて、体外受精の成功率を大幅に向上させるだけでなく、投薬の負担を軽減させる治療法を開発しています。
現在臨床研究にフェーズが移行しており、今後はCDMO含め外部機関や規制当局とのやりとりが増加することが想定されるため、本ポジションでは、同社の細胞製品の開発を加速し、国内外の規制当局への申請を円滑に進めるため、臨床開発およびプロジェクトマネジメントを担っていただきます。
【求める人材】
■プロジェクトマネジメントの基本的な知識とスキル
■英語での関連技術文書の読解・作成力(ビジネスレベル)
上記スキルをお持ちの方の内、下記いずれかに該当する方
■バイオ医薬品、細胞製品、再生医療等製品での臨床開発またはプロジェクトマネジメントの経験(3年以上)
■修士卒以上で医学生物学の研究のご経験があるコンサルご出身の方(未経験の方でもPJマネジメント経験をお持ちでしたら検討いただける可能性がございます)
【給与】
万円
賞与:別途4ヶ月分相当を支給予定
ストックオプション付与も検討可能
【勤務地】
東京都
【勤務時間】
09:00 - 18:00(コアタイム:11:00 - 16:00)
【雇用・契約形態】
【待遇・福利厚生】
健康保険、雇用保険、労災保険、厚生年金
通勤手当
時短勤務
【休日・休暇】
完全週休2日制(土日祝日)、年末年始、有給休暇(入社半年後、年間13日の有給休暇付与)
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