Director Clinical Development and Medical Assessment (f/m/d) (Referent/in - clinical trials (CRA))

STADA Arzneimittel GmbH What awaits you

You will take end-to-end responsibility for the clinical leadership of STADA's Specialty portfolio throughout the entire product lifecycle. As the internal clinical lead, you will ensure the clinical assessment of new opportunities as well as high-quality support for pipeline and market products, thereby enabling consistent, evidence-based decision-making from evaluation through development and approval to lifecycle management.

• You will assume overall clinical responsibility for key regulatory and development documents (INDs, IMPDs, protocols, interim analyses, CSRs, datasets) across all phases, including long-term follow-up
• You will drive the assessment of study quality - including study design, patient populations, endpoints (including PROs), strength of evidence, and overall study setup - and ensure robust results regarding efficacy, durability, response rate, function, and quality of life
• You will lead the identification of critical clinical risks, data gaps, biases, and limitations regarding efficacy, safety, and immunogenicity, and help shape the overall regulatory and evidence strategy
• You will define the clinical perspective on patient pathways, Standard of Care, competitive landscape, and lifecycle measures, including strategic expansion to further indications, populations, and dosage forms
• You will oversee the creation of high-quality clinical due diligence reports, red-flag summaries, and recommendation papers, and further develop STADA's due diligence frameworks as well as internal clinical competencies
• You will act as a Senior Clinical Expert in cross-functional BD teams, lead high-level scientific discussions with external partners, contribute strategic input to regulatory documents and timelines, and present clinical conclusions and recommendations to BD leadership and Executive Management

Who we are looking for

• You have an advanced degree in natural sciences or medicine (e.g., MD, MBBS, PhD, or PharmD)
• You bring more than 15 years of experience in clinical development or medical assessment
• You have practical experience in clinical due diligence and in supporting BD&L activities
• You possess proven expertise in the interpretation of CSRs and datasets and can evaluate clinical data across multiple therapeutic areas and modalities - including Small Molecules, biologics, and RNA-based therapies; experience with gene and cell therapies is a plus
• You have experience in ophthalmology, neurology, immunology, gene therapy, or rare diseases, ideally in the development of orphan drugs
• You have demonstrable experience in collaborating with key regulatory authorities, including EMA and FDA, within and beyond the scope of generating and interpreting clinical evidence
• You understand in detail how clinical evidence aligns with global regulatory expectations - including Scientific Advice processes, PIP requirements, long-term follow-up expectations, and clinical endpoints accepted by EMA and FDA
• You work proactively, structured, and reliably
• You feel comfortable in matrix organizations and intercultural environments and work effectively within them
• You speak English fluently