Clinical Development Lead

Grünenthal Group

Aachen, Germany

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

What the job looks like

Each day you´ll enjoy a variety of challenges, such as:

Creating and maintain the clinical development plan and the clinical strategy for a research & development project in alignment with the target product profile to which you also provide clinical input;
Ensuring that clinical strategy and clinical trial designs are aligned with and appropriately challenged by internal and external stakeholders;
Being accountable for ensuring timely delivery and adequate quality of the clinical parts of project and submission documentation as to ensure smooth internal decision-making and negotiations with health authorities and payors and a viable product label;
Understanding the competitive landscape and provide both business intelligence and you have medical expertise in relationship to the indication and compound;
Representing Grünenthal’s medical expertise in meetings with regulatory authorities, payors/HTA bodies, advisory boards and external medical experts;
Designing and execute clinical trials by knowledgeably managing external vendors/CROs;
Taking responsibility as medically qualified person according to ICH E6 and you are involved as such in the preparation of advanced protocol synopses, trial protocols, trial reports and investigator brochures;
Consulting with external medical experts and medical key external experts in setting up clinical development programs and individual clinical trials;
Being accountable for primary publications of trials in alignment with the publication strategy and in agreement with regulatory requirements.

What you´ll bring to the table

To make the most of this role and truly thrive, you should have:

At least 10 years of experience in clinical drug development and/or at least 15 years of experience in pharmaceutical industry;
A Medical Doctor with license to practice;
Proven expertise in Clinical Pharmacology, Pharmaceutical Medicine, or pharmacotherapy;
Proven experience in: experimental medicine, innovative POC designs, and modern trial designs;
Experience in designing and executing clinical trials through the use of external service providers/CROs;
Experience in working in highly matrixed/virtualized environment/organization;
Experience with budget management;
Fluent English skills; additional German language is a plus;
Clinical judgement experience - including a demonstrated track record of effectively applying medical and pharmaceutical expertise to make good clinical decisions.

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