Senior Manager, Clinical Science, Self Care

McNeil; Helsingborgs kommun; On-site; SEK 700,000 - 950,000; Full time

Job summary

McNeil is seeking a Senior Manager for Clinical Science to lead clinical strategies for product innovations at our Helsingborg location. This role has a strong emphasis on clinical development and regulatory submission.

The ideal candidate will have an advanced degree and substantial experience in managing clinical studies, along with excellent communication skills. Responsibilities include overseeing claims substantiation and maintaining relationships with stakeholders.

Qualifications

• Advanced degree (PhD, PharmD, or MD) strongly preferred.
• Experience in leading clinical development programs for regulatory submission.
• Experience in developing clinical designs and methodologies.
• Demonstrated ability to work closely with commercial partners.

Responsibilities

• Lead clinical strategy for product innovations and programs.
• Represent clinical strategies during health authority interactions.
• Ensure timely completion of clinical documentation.
• Build relationships with key stakeholders.

Skills

Clinical strategy development

Claim substantiation strategies

Project management

Communication skills

Understanding of scientific evidence

Education

Advanced degree (PhD, PharmD, MD)

Job description

Senior Manager, Clinical Science, Self Care

Role reports to: EMEA Translational Science RD Director

Work Location: Fully Onsite

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
• Klinisk prövning
• Engelska