Location: Leipzig, Germany (Hybrid / On‑site)
Reports to: VP of Clinical Development
Type: Full‑time, Senior Leadership
I am working with a fast‑growing, mission‑led oncology biotechnology company based in Leipzig, dedicated to advancing breakthrough therapies in immuno‑oncology and precision‑medicine. Our multi‑platform pipeline includes ADCs, cell therapies, and transformative biologics with global ambitions. Join our experienced team and help shape the future of cancer care.
What You’ll Do:
As Senior Director Clinical Development, you will play a pivotal role in our clinical innovation journey. You’ll:
* Lead design, execution, and oversight of clinical development programs from Phase I/II through Phase III, ensuring scientific rigor, regulatory compliance, and patient safety.
* Define and translate Target Product Profiles (TPPs) into strategic clinical plans aligned with business, regulatory, and scientific goals.
* Oversee medical oversight and safety, risk‑benefit assessments, and collaborate closely with pharmacovigilance.
* Serve as medical lead in cross‑functional program teams (Regulatory, Biostatistics, Clinical Operations, Translational Medicine etc.).
* Liaise with Health Authorities (EMA, FDA, etc.), key opinion leaders, academic partners and external stakeholders.
* Mentor and build high‑performing clinical teams; manage in matrixed environments with multiple ongoing trials.
* Drive innovation in trial designs (e.g. adaptive designs, digital endpoints, synthetic control arms, RWE/HEOR) to accelerate timelines and maximize patient impact.
What We’re Looking for
RequirementDetails
Education & Scientific Credentials
MD, MD/PhD, or equivalent with strong clinical background in oncology / immuno‑oncology.
Experience
~10+ years in clinical development roles in biotech/pharma, including leading global oncology programs through late‑stage trials and regulatory submissions.
Technical Expertise
Deep understanding of trial design, companion diagnostics, translational modeling, clinical pharmacology, biostatistics. Experience with confirmatory Phase III trials.
Regulatory & Medical Oversight
Proven interactions with EMA/FDA; experience preparing clinical trial applications, MAAs, responses to regulatory agencies. Excellent safety and data integrity track record.
Leadership Style
Strong cross‑functional leader, hands‑on, able to influence without full line authority; excellent communication skills.
Languages & Location
English fluent (written and spoken); German is a plus. Willingness to be based in Leipzig or commute regularly.
What We Offer
* Competitive salary & equity options
* Flexible working model & hybrid arrangements.
* State‑of‑the‑art labs, access to cutting‑edge technologies, and a culture of innovation.
* Opportunities for professional growth: seminars, conferences, leadership development.