Clinical Strategy Project Manager Job Details | Coloplast A/S

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Clinical Strategy Project Manager

Location:

Humlebæk, DK

Job Family:

Research & Development

Country/Region:

Denmark

In this business-critical role, you will drive the clinical strategy for innovation projects and support our ambition to bring clinically differentiated products to market.

Together, we define and deliver the clinical strategy
You will join our high-performing team of project managers, biostatisticians, real-world evidence managers and medical writers. The department is part of Payers & Evidence within Chronic Care Commercial. We define the clinical pipeline and strategic evidence plans and generate a broad range of pre- and post-market clinical evidence to support product development, regulatory and reimbursement requirements, and market uptake.

You take on a strategic role
As a project manager, you will work in a dynamic environment and lead the clinical strategy track across the product lifecycle. Depending on the project scope, you will coordinate a cross-functional team of internal and external stakeholders. Together, you will define and execute the clinical evidence strategy, generating the appropriate mix of pre- and post-market evidence—from traditional clinical investigations to post-market clinical follow-up surveys, case series, real-world evidence, registries, health-economic evidence and scientific publications. You will also provide strategic scientific and clinical advice and deliver high-quality clinical documentation.

A key responsibility will be to align with R&D, Marketing, Market Access, Regulatory Affairs and the Payers & Evidence leadership team. You must therefore be able to collaborate and communicate effectively across all levels of the organization, from senior management to core project team members.

Your key responsibilities will be to:
• Lead the clinical strategy track in projects by defining an integrated evidence plan covering the pre- and post-market clinical activities required to support R&D, Regulatory Affairs, Market Access and market uptake
• Engage and align critical stakeholders throughout the project
• Ensure that activities are delivered on time, to the required quality and within the agreed budget
• Keep management informed of progress, decisions and key risks
• Contribute to strategic, regulatory and operational documentation
• Identify risks related to the clinical strategy and develop appropriate mitigation plans

Pragmatic mindset and clinical experience
We are looking for an ambitious and pragmatic person who drives projects forward, challenges established ways of working and turns ideas into action. You bring a strong scientific background and the judgment to select evidence approaches that are both rigorous and fit for purpose. You understand clinical processes and the guidelines and regulations governing medical and clinical research. Just as importantly, you bring positive energy, a genuine can-do attitude and a great sense of humor to a collaborative team environment.

Moreover, you bring
• Relevant experience in project and/or team management within the clinical or medical field
• Experience in clinical development, clinical project management, medical affairs or medical marketing, with a focus on communicating and reporting clinical outcomes
• Experience in external networking and managing external partners and key opinion leaders
• Experience working with international, cross-border teams and/or organizations
• Experience in biomedical research and a solid understanding of clinical and statistical methodology
• The ability to create clarity, maintain an overview and deliver results in a complex, fast-paced environment
• Persistence, sound judgment and the confidence to provide direction
• A relevant master’s degree
• An open and positive mindset, a pragmatic can-do attitude and a great sense of humor
• Excellent written and spoken English communication skills

Interested?

If you would like to know more about the position, please contact Zenia Størling, Senior Director of Evidence & Clinical Strategies, at dkzenst@coloplast.com. We review applications and invite candidates to interview on an ongoing basis, so we encourage you to apply as soon as possible. The position will remain open until a suitable candidate has been found.