Stada Arzneimittel Bad Vilbel vor 1 Wochen

Director Clinical Development and Medical Assessment (f/m/d)

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Around 11,700 employees live our values of Integrity, Entrepreneurship, Agility and One STADA.

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Do you want to become part of a dynamic, international team and grow with us?

PROs), evidence robustness and overall study set up, ensuring robust efficacy, durability, responder, functional and QoL outcomesYou lead the identification of critical clinical risks, data gaps, biases and limitations regarding efficacy, safety and immunogenicity and shape the overarching Regulatory and evidence strategyYou define the clinical perspective on patient pathways, standard of care, competitive landscape and lifecycle measures, including strategic expansion into further indications, populations and presentationsYou oversee the development of high quality clinical due diligence reports, red flag summaries and recommendation documents and enhance STADA’s due diligence frameworks and internal clinical capabilitiesYou act as the senior internal clinical expert in cross functional BD teams, lead high level scientific discussions with external partners, provide strategic input into Regulatory documents and timelines, and present clinical conclusions and recommendations to BD leadership and Executive ManagementWho we are looking forYou hold an advanced scientific or medical degree (MD, MBBS, PhD, or PharmD)You bring more than 15 years of clinical development or medical evaluation experienceYou have hands-on experience in clinical due diligence and BD&L supportYou demonstrate deep expertise in interpreting CSRs and datasets, with a proven ability to evaluate clinical data across multiple therapeutic areas and modalities, including small molecules, biologics, and RNA-based therapies, and experience with gene and cell therapies is a plusYou possess experience in ophthalmology, neurology, immunology, gene therapy, or rare diseases, with a preference for orphan drug developmentYou have demonstrated experience engaging with major regulatory agencies, including EMA and FDA, within and beyond the scope of clinical evidence generation and interpretationYou have a strong understanding of 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 FDAYou are proactive, organized, and reliable in your working styleYou work effectively in matrix organizations and intercultural settingsYou are fluent in English What we offer An open corporate culture with fast decision-making processes and a lot of potential for your personal developmentIndividual development and training opportunitiesFlexible working hours and mobile working up to 2 days per week (depending on the job profile)Job ticket for the RMV region and Job BikeChildcare allowanceHealth-promoting offers such as Wellpass or the STADA Gym (free of charge)Numerous additional benefits such as group accident insurance or supplementary pension schemeSubsidized cafeteriaWe look forward to receiving your application via our career portal.

At jobs.stada.com you will also find numerous other job opportunities, as we are always looking for motivated talents who can strengthen our team with their expertise and personality. "Caring for People's Health as a Trusted Partner" - This purpose motivates us at STADA every day to improve the health of people worldwide.

With our wide range of generics, consumer health products and specialty pharmaceuticals, we offer patients, doctors and pharmacists a wide range of therapeutic options. Together we are on an exciting growth journey and want to successfully shape the future of STADA.

Then apply now as: Director Clinical Development and Medical Assessment (f/m/d) Bad Vilbel | Germany (DE) | Full-time | Permanent | Portfolio & Product Development | Professionals What you can expectYou provide end-to-end clinical leadership for STADA’s Specialty portfolio across the full product lifecycle.

As the internal clinical owner, you ensure rigorous clinical assessment of new opportunities and high-quality support for both pipeline and on-market products, enabling consistent, evidence-based decision making from evaluation through development, launch, and lifecycle management.You provide senior clinical oversight for key regulatory and development documents (INDs, IMPDs, protocols, interim analyses, CSRs, datasets) across all phases and long term follow upYou drive the evaluation of study design quality, patient populations, endpoints (incl.

Do you have further questions? Then please reach out to recruiting@stada.de. We will consider requests to work part-time on an individual basis.

Please contact us in advance by e-mail (recruiting@stada.de) and let us know how many hours per week you would like to work.STADA Group promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology or sexual orientation.

We use the strength of this diversity to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation and the promotion of an inclusive working environment. #LI-DH1

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