Description du poste
Santhera Pharmaceuticals est une entreprise suisse spécialisée dans les produits pharmaceutiques.
Tâches
- Diriger la stratégie de développement clinique au niveau mondial.
- Superviser les programmes de développement à travers toutes les phases.
- Recruter et encadrer des talents cliniques de haut niveau.
Compétences
- Médecin avec 10 ans d’expérience en développement clinique.
- Excellentes compétences en communication et interpersonnelles.
- Compétences analytiques et statistiques solides.
Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on medical science and the development and commercialization of innovative pharmaceutical products for the treatment of rare neuromuscular diseases with high unmet medical need. For further information, please visit the company’s website www.santhera.com Come and join our team to contribute to providing treatment options for patients with rare diseases that have a severe impact on the lives of affected children and adults. You can make a difference as:
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
Program Oversight
- 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
Scientific & Regulatory Excellence
- 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.
Team Leadership
- 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.
Required Qualifications & Experience
- 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)
Desirable Qualifications & Experience
- 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.
Required Competencies & Skills
- 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.
For this position, the relevant working/residency permit, or Swiss citizenship is required. If you are interested in a multicultural, challenging, and innovative working environment and your profile matches our requirements, we are looking forward to receiving your online application in English via LinkedIn or Email, at E-Mail schreiben Strictly no agencies: Recruitment agencies are kindly invited to refrain from sending unsolicited CVs to Santhera.
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