Senior Manager, Clinical Science, Self Care

Senior Manager, Clinical Science, Self Care

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

EMEA Translational Science RD Director

Locatie:

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

Werklocatie:

Volledig ter plaatse

Wat je gaat doen

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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