Senior Manager, Clinical Science, Self Care

Kenvue-1; Helsingborgs kommun; On-site; SEK 650,000 - 850,000; Full time

Job summary

Kenvue-1では、スウェーデンのヘルシンボリにて、シニアマネージャー、臨床科学、自社ケアの役割を募集しています。このポジションでは、臨床開発プログラムのリードと、新製品の臨床戦略を担当していただきます。

理想的な候補者はPhD、PharmD、またはMDを持ち、臨床研究の実行や医学製品開発における経験が必要です。多国籍環境での柔軟性も求められます。

Qualifications

• 規制提出に向けた臨床開発プログラムをリードする経験。
• 臨床研究の設計と方法論を開発する能力。
• ビジネスコンテキストを理解し、商業パートナーと密接に連携を取る能力。

Responsibilities

• 新製品の臨床戦略リードを務めること。
• 臨床研究の計画、デザイン、実行、報告を行うこと。
• 関係者との強力な関係を構築して維持すること。

Skills

臨床開発プログラムの策定

臨床研究の実行

科学的証拠の翻訳

マルチプロジェクト管理

優れたコミュニケーションスキル

Education

PhD または PharmD または MD

Job description

Senior Manager, Clinical Science, Self Care

私たちがしていること

私たち Kenvue は、日々のケアが持つ驚くべき力を信じています。 100年以上の伝統と科学に根ざし、Neutrogena®, Aveeno®, Tylenol®, Listerine®, Johnson’s® and BAND-AID® など、皆様が既にご存じでご愛用いただいているアイコニックなブランドを提供しています。科学は私たちの情熱であり、ケアは私たちの才能です。

Who We Are

私たちのグローバルチームは、インサイトとイノベーションに情熱を注ぎ、最高の製品をお客様にお届けすることに全力を注ぐ、多様で優秀な22,000人以上の社員で構成されています。専門知識と共感力を備えた Kenvuer であることは、毎日何百万人もの人々の生活に影響を与える力を持つことを意味します。私たちは、人を第一に考え、全身全霊をもってケアし、サイエンスで信頼を獲得し、勇気をもって解決します。私たちとあなた自身の未来を、共に切り開いていきましょう。

Role reports to:

EMEA Translational Science RD Director

場所:

Europe/Middle East/Africa, Sweden, Skane, Helsingborg

勤務地:

フルオンサイト

あなたがすること

Key responsibilities

• Serves as clinical strategy lead for new product innovations and clinical programs in all phases of product development which include planning, design, execution, and reporting of clinical studies for assigned categories.
• Responsible for representing clinical strategies during health authority interactions.
• Shape and deliver claims, claims roadmaps, creative claims substantiation strategies and communication pipeline targeting both consumers and healthcare professionals.
• Play a claims subject matter expert role in understanding the relevant science to provide contributions and/or make recommendations to strengthen claims and or science storytelling to cross-functional project teams.
• Championing a human-centric innovation mindset
• Assures timely and quality completion of investigator brochures, study protocols, clinical study reports, and any documents needed for regulatory filing as well as timely and accurate publication of completed research.
• Build and maintain strong relationships with key stakeholders, including internal and external scientific partners, to advance research and development efforts.
• Responsible for clinical evaluation reports for medical devices in development and for post-market clinical follow up studies for in-market devices in their assigned need state.
• Support activities as needed including, but not limited to, Core Data Sheet, review of periodic safety reports, ingredient/product issue management, and benefit/risk challenges.

Requirements

• An advanced degree (e.g., PhD or PharmD or MD) is strongly preferred
• Experience in mapping out and leading full clinical development programs for regulatory submission is strongly preferred.
• Experience in developing clinical designs and methodologies, with execution of clinical studies.
• Experience in developing compelling claims & communication strategies and translating scientific evidence into robust claims substantiation.
• Demonstrated ability to understand the business context and work closely with commercial business partners in the development of over-the-counter medicinal products.
• Experience/leadership in a people/team management capacity is a plus.
• Must have ability and flexibility to work in a global environment.
• Ability to manage multiple projects and mentor junior colleagues.
• Excellent verbal and written communication skills

Kenvue Helsingborg

The Kenvue site in Helsingborg, Sweden is the home of the strong and growing brand NICORETTE®, a global market leader in smoking cessation. In 2021 our production facility was recognized as a Lighthouse by World Economic Forum, marking us as a beacon in The Fourth Industrial Revolution.

The Helsingborg site is one of the largest employers in the city of Helsingborg, and the business is divided in two separate departments: Operations, where we house our manufacturing activities and R & D, our global development center for excellence working in three therapeutic areas for selfcare treatments: Smoking Cessation, Digestive Health and Cough & Cold. For more information, click here

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