Associate Clinical Development Lead (m/f/d)

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