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Senior Director Clinical Development - Late Stage & ADC Oncology(m/w/x)
Overseeing late-stage ADC oncology clinical trials and guiding matrix teams. M.D. degree with extensive immuno-oncology/oncology experience required. Annual bonus, equity, and flexible hours.
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Anforderungen
- M.D. degree with scientific/clinical background in Immuno-Oncology or Oncology
- Extensive experience leading clinical development programs (Phases I-III)
- Expertise in advanced clinical study designs
- Expertise in companion diagnostics for patient selection
- Expertise in translational modeling
- Expertise in biostatistics
- Expertise in confirmatory Phase III trial design
- Proven experience interacting globally with health authorities (EMA, FDA)
- Successful registration advantageous
- Strong medical acumen in monitoring safety/efficacy data
- Strong medical acumen in managing patient-centric drug development
- Exceptional leadership skills to mentor teams
- Exceptional leadership skills to accelerate capabilities
Aufgaben
- Collaborate with the VP of Clinical Development to drive innovative strategies
- Oversee the design and execution of clinical trials across all phases
- Ensure data integrity, patient safety, and regulatory approval
- Lead matrix teams to deliver impactful results
- Guide decisions with scientific rigor and medical insight
- Lead clinical trial design for new compounds from early to late-stage development
- Collaborate with the VP to operationalize clinical strategies for assigned portfolios
- Ensure alignment across functions
- Serve as Program Lead, guiding core teams and driving program strategy
- Prepare submission processes
- Oversee medical aspects of studies to ensure patient safety
- Conduct risk-benefit assessments
- Address medical queries
- Innovate in trial design using digital endpoints and real-world evidence
- Develop Investigator’s Brochures, NDAs, and Clinical Study Reports
- Build strong relationships with external stakeholders
- Represent the team in governance meetings
Berufserfahrung
Ausbildung
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Benefits
- Annual bonus
- Equity
- Flexible hours
- Vacation account
- Digital learning
- LinkedIn Learning
- Performance and talent development
- Leadership development
- Apprenticeships
- Support for your full potential
- Company bike
- Job ticket
- Deutschlandticket
- Employer-funded pension
- Childcare
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