Clinical Development Lead CRM

vor 1 Tag

Biberach an der Riß, Deutschland BI International GmbH Vollzeit

**The Position**:
Are you ready to take on a pivotal leadership role in shaping the future of innovative clinical development? As Clinical Development Lead (CDL) for Vicadrostat-Empagliflozin, based in Germany, you will hold full strategic and operational accountability for the clinical development of this asset.
Within the Global Clinical Development CRM Department, you will be responsible for designing and executing a forward-looking, data-driven clinical development plan that aligns seamlessly with the asset's target product profile, value proposition, and corporate objectives.
In this role, you will provide strategic direction and scientific leadership to a dedicated team of Clinical Program Leaders, driving excellence and innovation in clinical development. If you are passionate about making a meaningful impact and leading with vision, this opportunity is for you

**Tasks & responsibilities**:

- As part of the Global Brand team, you are empowered to drive strategic recommendations and operational decisions for Senior Management endorsement and the governance committees.
- For your post-PoC asset Vicadrostat-Empagliflozin, you are accountable for the development and continuous update of a consistent high quality clinical development plan at all phases post-PoC in the context of holistic evidence generation and with the objectives of achieving regulatory approval and maximizing the asset's potential and value proposition.
- You will be a key contributor to the asset strategy, including the Target Product Profile (TPP), Asset Narrative, and ASSAY value proposition.
- You will steer the clinical development strategy through insight generation, evidence interpretation, and enterprise-level decision-making, ensuring that clinical development is scientifically rigorous and strategically aligned with regulatory, access, and commercial goals.
- As CDL you will lead and manage a team of (Senior) Clinical Program Leaders, Study Physicians, and Scientific Project Coordinators assigned to the asset.

**Requirements**:

- MD or PhD with profound experience in Medicine, preferably Cardiology, Nephrology, or Internal Medicine; Clinical or Pharma experience in the US is a plus.
- Long-term experience Clinical Drug Development in pharma industry and/or academia, preferably in an international role.
- Several years of experience in a leadership role in a matrix environment.
- Advanced knowledge in the lifecycle stages of medicinal product, including pre-launch/launch/post-launch activities and dynamics.
- In-depth regulatory expertise with prior successful interactions with various regulatory agencies like FDA and EMA
- Excellent leadership communication (oral and written) as well as negotiation and influencing skills. Ability to act with grace and resilience under pressure as well as excellent presentation, training and facilitation skills

**Ready to contact us?**:
Recruitment process:
Step 2: Virtual meeting in the month of August & beginning of September
Step 3: On-site interviews beginning mid / end of September

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