Head of Clinical Development
Veröffentlicht:
12 April 2025Pensum:
100%Vertragsart:
Festanstellung- Arbeitsort:Pratteln
- Gehaltsschätzung von jobs.ch:Melde dich an, um die Schätzung von jobs.ch zu sehen
Job-Zusammenfassung
Santhera Pharmaceuticals ist ein Schweizer Unternehmen, das sich auf innovative Medikamente fokussiert. Unterstütze uns bei der Behandlung seltener Krankheiten!
Aufgaben
- Leitung globaler klinischer Entwicklungsprogramme von Design bis Ausführung.
- Zusammenarbeit mit Behörden zur Sicherstellung der Einhaltung von Vorschriften.
- Führung eines interdisziplinären Teams zur Entwicklung innovativer Therapien.
Fähigkeiten
- MD mit über 10 Jahren Erfahrung in der klinischen Entwicklung, insbesondere bei seltenen Krankheiten.
- Ausgezeichnete analytische Fähigkeiten und Kommunikationskompetenz.
- Erfahrung in der Leitung interdisziplinärer Teams und Projektmanagement.
Ist das hilfreich?
Head of Clinical Development
Location: Pratteln, Switzerland (Hybrid) Who you are
We're looking for a visionary clinical leader to shape and drive our global clinical development strategy. As Head of Clinical Development, you'll play a critical role in bringing transformative therapies to patients with rare diseases. You'll lead a cross-functional team of clinical scientist, medical directors, non-clinical function and oversee development programs across all phases, and ensure our clinical strategy is innovative, scientifically sound, and aligned with regulatory and commercial goals. Scope of Work
This senior leadership role will shape global clinical programs, drive innovation in trial design, and ensure alignment with regulatory, scientific, and commercial goals. As a key member of the CMO leadership team, you will partner across functions to accelerate the development of transformative therapies for patients with rare and serious diseases. You will also represent Clinical Development in executive discussions and external engagements, contributing to our strategic direction and long-term success. Key Responsibilities
Strategic Leadership
- Define and align clinical strategy with company objectives
- Represent Clinical Development in Executive leadership forum discussions
- Prioritize pipeline programs based on risk, value, and timing
- Navigate corporate pivots, in-licensing opportunities, and evolving market landscapes
- Build a future-ready team and foster a culture of excellence
- Lead global clinical development programs from design to execution and reporting
- Ensure alignment with regulatory, scientific, and access goals
- Drive consistency and quality across protocols, study documents, and reports
- Manage timelines, budgets, and resource allocation
- Oversee lifecycle planning, including post-approval strategy
- Provide clinical input into country/regional execution strategies.
- Leverage real-world data to inform development plans
- Apply innovative trial methodologies for rare disease indications.
- Guide dose selection, PK/PD, and pediatric extrapolation strategies.
- Ensure clinical strategy leverages latest scientific and technical advances.
- Collaborate with biostatistics to optimize design in small and heterogeneous populations
- Incorporate external data sources (registries, RWE) into development plans.
- Ensure high-quality clinical content for global submissions
- Build trusted relationships with regulators, advisors, and partners
- Support due diligence and integration of new programs
- Oversee design optimization for out-licensed assets where company is MAH/Sponsor.
- Recruit, mentor, and retain top-tier clinical talent
- Develop future leaders and succession plans
- Foster a growth mindset within the team, particularly during change and growth cycles.
- Ensure clarity of expectations, accountability, and shared goals.
- Facilitate regular communication and alignment across functional teams.
- Act as a role model for integrity, resilience, and patient-centered leadership.
- Medical Doctor (MD) with 10+ years of clinical development experience in the biopharmaceutical industry, including substantial time in smaller biotech environments and demonstrated success in rare diseases.
- Proven track record of leading cross-functional teams through the design and execution of clinical development plans, including regulatory submissions (IND/NDA/BLA/MAA) and interactions with global health authorities.
- Experience with innovative and adaptive study designs, pediatric extrapolation strategies, PK/PD and PopPK modeling, and dose selection methodologies.
- Strong analytical mindset with the ability to interpret complex clinical and statistical data and contribute to key documents, including study protocols, reports, and submission packages.
- Numerate with proven statistical skills to interpret, discuss and present clinical data
- Advanced medical writing skills
- Fluency in English (German or any other language is a plus)
- Previous experience in the Therapeutic Area or Rare Disease is highly desirable.
- Additional experience in special assignments in medical or regulatory will be considered a plus.
- Excellent verbal and written communication and interpersonal skills.
- Excellent statistical and analytical skills to interpret complicated datasets
- Project management, planning and organizing.
- Is curious, can deal with ambiguity and will make informed decisions and effectively lead teams
- Mission focused and motivated, solution oriented, resilient, energy and drive
- Proficient in IT, including email, Microsoft Office
- Ability to travel as required.
