Associate Clinical Development Lead (m/f/d)

Country:  Germany
City:  Aachen
Department:  Research & Development
Job ID:  41875

 

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:

  • Accountable for ensuring timely delivery and adequate quality of the clinical trials and submission documentation (e.g. IND/CTA, Scientific Advice, NDAs/BLAs/MAAs, supplements/variations) including responses documents as to ensure smooth internal decision-making / negotiations with health authorities and payors and a viable product label in line with the TPP 
  • Ensures that trial designs are aligned with the Clinical Development Plan and appropriately challenged by internal (e.g. Commercial, Regulatory, etc.) and external stakeholders (e.g. medical experts, patients, regulators, etc.)
  • Understands the competitive landscape and provides both business intelligence and medical expertise in relationship to the trial, indication and compound
  • Represents GRT medical expertise in meetings with regulatory authorities, payors/HTA bodies, advisory boards, external medical experts, etc.
  • Creates and maintains the Clinical Development Plan and strategy in alignment with the TPP for early development compounds; provides clinical input in the TPP

 

What you´ll bring to the table
To make the most of this role and truly thrive, you should have:

  • Proven experience in clinical drug development and/or experience in pharmaceutical industry
  • Expertise in Clinical Pharmacology, Pharmaceutical Medicine, or pharmacotherapy
  • Proven experience in: experimental medicine, innovative POM, POC, POP designs, modern designs
  • Experience in designing, executing and overseeing clinical trials by knowledgeably managing external vendors/CROs
  • Experience in working in highly matrixed/virtualized environment/organization
  • Experience with budget management
  • Clinical Judgment Experience - including a demonstrated proven track record of effectively applying medical expertise to make good clinical decisions, in accordance with appropriate SOP(s) and regulatory standards
     


 

About Grünenthal

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned 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 focussing 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 more than 100 countries. In 2021, Grünenthal employed around 4,500 people and achieved sales of € 1.5 bn.

Your HR contact:
Simona Frings

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

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