Program Manager, CDx

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Posting Title       : Program Manager

Hiring Legal Entity    : Life Technologies Japan Ltd.

Division                     :CSD

Job Band                   : 6  *Manager role is expected for Band 6 or higher

No. of subordinates  : 0

About Us

Here at Thermo Fisher Scientific, our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research, clinical to commercial production means you can have a broad and significant impact. All while working in an environment where you will be supported, valued and rewarded for your performance. Join our Sales & Marketing team with an unmatched depth of capabilities and help our customers solve some of the world’s toughest challenges.

How will you make an impact?

As a Program Manager you will lead the development, external relationship, and regulatory submission of Next Generation Sequencing (NGS) based Oncology Companion Diagnostic (CDx) assays within the Clinical Sequencing Division. You will complete program goals from initial concept and deal agreement through successful commercialization in coordination with external clients.

What will you do?

• Serve as Core Team Lead and external point of contact for multiple CDx programs.
• Proactively identify risks and mitigations: Develop plans to address, facilitate tradeoff decisions at the portfolio level, raise to key internal partners, remove obstacles, and seek resolution.
• Develop and control program timelines in conjunction with both internal functions and external clients.
• Conduct internal and external team meetings: Ensure decisions are made with data, supervise progress, identify & implement risk mitigations, and action items are completed to support successful program execution.
• Ensure compliance to company Product Commercialization Process (PCP) and Quality Management Systems (QMS) for developing regulated products.

Qualification

Must

• Experience with commercialization of product, preferably in diagnostics business
• Undergraduate Degree (BS in Molecular Biology, Genetics, or Engineering preferred
• Strong verbal and written communication skill in both Japanese and English

Preferred

• Experience with regulated medical devices development
• Experience with project management
• Proficiency with "Project Management software" to lead intricate program timelines and resources
• Led multiple product development programs with an external partner to completion
• Strong background in molecular biology preferably in NGS technology
• Exceptional leadership, time management, facilitation, and organizational skills
• Able to work under pressure and in uncertain environment
• Good interpersonal skills to work across functions
• Ability and willingness to travel

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Benefits:

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension/retirement, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

<以下日本語>

Essential Duties and Responsibilities

プログラムマネージャーとして、クリニカルシーケンス部門において、次世代シーケンス（NGS）ベースのがんコンパニオン診断（CDx）アッセイの開発、対外関係、薬事申請を担当します。外部顧客と連携し、初期コンセプトや契約合意から商業化の成功まで、プログラム目標を達成します。

Direct Report to:  Manager, Program management, Japan

Job Description

<業務内容>

• 複数のCDxプログラムのコアチームリードおよび外部窓口としての役割を果たす。
• リスクと緩和策を積極的に特定する： 対処計画を策定し、ポートフォリオレベルでのトレードオフ決定を促進し、主要な社内パートナーに提起し、障害を取り除き、解決を求める。
• 社内部門および社外顧客と連携して、プログラムのタイムラインを作成し、管理する。
• 社内外のチームミーティングを実施する： データに基づいて意思決定が行われ、進捗状況を監督し、リスク軽減策を特定・実施し、アクションアイテムが完了していることを確認し、プログラムの成功をサポートする。
• 規制製品開発のための製品商業化プロセス(PCP)および品質管理システム(QMS)の遵守を保証する。

【応募要件】

必須要件

• 製品商業化プロセスの経験（製薬、診断薬ビジネスでの経験があるとなお良い
• 学士号以上（分子生物学、遺伝学、または工学の理学士号であると望ましい
• 日英両言語でのコミュニケーション能力

あると好ましい要件

• 外部パートナーと共に複数の製品開発プログラムを完成に導いた経験
• 規制医療機器の開発経験
• プロジェクトマネジメントの経験
• プロジェクトマネジメントソフトウェアに習熟し、複雑なプログラムのタイムラインとリソースをリードできる方
• 分子生物学（できればNGS技術）の強力なバックグラウンド
• 卓越したリーダーシップ、時間管理、ファシリテーション、組織能力
• プレッシャーや不確実性の高い環境下での業務遂行能力
• 部門横断的な仕事ができる対人能力
• 出張が可能であること（国内の学会もしくは海外出張が発生する可能性がある