Director Clinical Development and Medical Assessment (f/m/d) (Bad Vilbel, HE, DE, 61118)

"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.

Around 11,700 employees live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA.

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

You 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 up

You drive the evaluation of study design quality, patient populations, endpoints (incl. PROs), evidence robustness and overall study set up, ensuring robust efficacy, durability, responder, functional and QoL outcomes

You lead the identification of critical clinical risks, data gaps, biases and limitations regarding efficacy, safety and immunogenicity and shape the overarching Regulatory and evidence strategy

You define the clinical perspective on patient pathways, standard of care, competitive landscape and lifecycle measures, including strategic expansion into further indications, populations and presentations

You 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 capabilities

You 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 Management

Who we are looking for

You hold an advanced scientific or medical degree (MD, MBBS, PhD, or PharmD)

You bring more than 15 years of clinical development or medical evaluation experience

You have hands-on experience in clinical due diligence and BD&L support

You 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 plus

You possess experience in ophthalmology, neurology, immunology, gene therapy, or rare diseases, with a preference for orphan drug development

You have demonstrated experience engaging with major regulatory agencies, including EMA and FDA, within and beyond the scope of clinical evidence generation and interpretation

You 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 FDA

You are proactive, organized, and reliable in your working style

You work effectively in matrix organizations and intercultural settings

You are fluent in English

What we offer

An open corporate culture with fast decision-making processes and a lot of potential for your personal development

Individual development and training opportunities

Flexible working hours and mobile working up to 2 days per week (depending on the job profile)

Job ticket for the RMV region and Job Bike

Childcare allowance

Health-promoting offers such as Wellpass or the STADA Gym (free of charge)

Numerous additional benefits such as group accident insurance or supplementary pension scheme

Subsidized cafeteria

We 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. 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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