ペイシェントオペレーションマネージャー【細胞治療分野】

Job Details

<求人タイトル>

16757 ペイシェントオペレーションマネージャー【細胞治療分野】

<職務内容>

Position Summary:
・This role will serve as the technical operations single point of contact for Apheresis Centers located within the designated region of Japan.
・This role will be based out of the corporate offices in Tokyo, Japan. Travel up to 60% of time
within Japan may be required.
・Be part of the team building a leading edge Clinical and Commercial CAR T Platform that serves our patients with novel CAR T Therapies.

Key Responsibilities:
・Develop and foster relationships with Apheresis Center Staff for assigned region.
・Work with Clinical and Commercial CAR T teams to establish the apheresis collection footprint to support the clinical trial and commercial site plans for assigned region/country.
・Coordinate with internal teams and collection site staff to ensure all collection site onboarding activities are successfully completed and sites are prepared to perform collections within the required timelines.
・Communicate collection site on-boarding status to Clinical and Commercial teams and develop and execute mitigation plans for any delayed timelines.
・Perform technical site assessments and train collection center staff on the collection requirements and attend site audits as required
・Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centers.
・Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.
・Manage rollout of process changes to assigned sites.
・Collect VOC (voice of customer) and VOB (voice of business) feedback used for continuous
operations improvement
・Collect and enter data into electronic data management systems
・Represent the department on cross-functional project teams, as requested.
・Comply with applicable SOP’s and regulations.
・部下なし管理職ポジジョンになります。

<応募要件>

・Ability to rapidly solve problems and deal with organizational complexity
・Ability to prioritize and complete work with sense of urgency based on criticality
・Medical, scientific and clinical knowledge
・Knowledge of applicable regulations and standards
・High attention to detail skills
・High organization skills with ability to multi-task several tasks in parallel
・Required Undergraduate Degree in Life Sciences or Engineering (Registered Nurse, Biomedical Engineer)
・Required minimum 5 years of experience in a regulated environment either hospital or
pharmaceutical/biotech
・Required written and verbal fluency in Japanese and English

<会社概要>

オンコロジー・ヘマトロジー・再生医療領域等に注力する大手外資系スペシャリティファーマです。再生医療を含めて今後も更なるビジネスの拡大が見込まれている企業になります。スピード感にあふれ意思決定がとても早く、新しいことにどんどんチャレンジをしていきたい方にとって、とても魅力的な会社です。働きやすい環境も整っており、コアタイムなしのスーパーフレックス制度、在宅勤務制度もございます。

<注目ポイント>

当該企業が特に注力する疾患分野にて、新部門の立ち上げに伴い募集が開始されたポジションです!血液センターや医師との交渉・コミュニケーションから細胞治療法ビジネスの拡大を図ります。細胞治療に関するご経験、医療機器業界の知識、臨床工学技士の資格、医師とのコミュニケーションスキルなどを活かしていただけます。ご興味がございましたら、是非お早めにお問い合わせください。

Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company