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Clinical Development Lead (f/m/d)

Country:  Germany
City:  Aachen
Department:  Research & Development
Job ID:  41078

 

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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About Grünenthal

Grünenthal is a global leader in pain management and related diseases. As a science-based, fully-integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focusing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. Our products are available in approx. 100 countries. In 2022, Grünenthal employed around 4,400 people and achieved revenues of € 1.7 bn.

Your HR contact:
Thorsten Hagens

Meet our teams
Website: careers.grunenthal.com
LinkedIn: Grunenthal Group
Instagram: @grunenthal

Meet our teams
Website:
careers.grunenthal.com
LinkedIn:
Grunenthal Group
Instagram:
@grunenthal

Apply now »