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EMEMD Serono

Sr. Director, Compound Operational Lead(m/w/x)

Eysins
Vollzeitmit HomeofficeSenior

Driving patient-centric clinical trials from First-in-human to launch for medicines in Oncology, Neurology, Fertility at a biopharmaceutical company. 12-15 years leading complex global clinical trial programs required; advanced Life Sciences degree preferred. Strategic leadership for global clinical programs with direct impact on patient outcomes.

Anforderungen

  • US work authorization eligibility
  • Minimum BA or BS degree
  • Advanced degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals) or equivalent medical background (preferred)
  • 12-15 years direct experience leading complex global clinical trial programs in pharmaceutical industry
  • 5-7 years senior leadership experience directing large-scale global team operations
  • Experience developing and mentoring junior/mid-level team members in matrix environment
  • Extensive project management experience in diverse settings
  • Deep and broad expertise with in-depth knowledge of competitors
  • In-depth knowledge of industry challenges and developments
  • Ability to identify business opportunities
  • Strong leadership competencies
  • Influencing skills with senior and cross-functional leaders
  • Effective oral and written communication skills
  • Ability to influence, inform, and guide large global operational team
  • Broad clinical operations experience
  • Strong project management skills
  • Proven teambuilding skills
  • Ability to foster partnerships across projects and multidisciplinary teams
  • Comprehensive expertise in drug development
  • Profound knowledge of clinical development interfaces and interdependencies

Aufgaben

  • Provide operational oversight and leadership for clinical programs
  • Provide strategic input for clinical program planning and execution
  • Lead clinical programs from First-in-human to launch
  • Drive faster, cost-efficient, patient-centric trials
  • Ensure trials meet industry standards
  • Apply state-of-the-art project management methodologies
  • Align trials with global drug development processes
  • Prepare and present operational content for governance discussions
  • Provide critical operational input for strategic discussions
  • Lead development of clinical operational strategies
  • Deliver clinical development plans
  • Ensure plans meet budget, timeline, and quality standards
  • Represent GDO within the Global Program Team
  • Serve as key GDO operational contact for programs
  • Contribute to developing annual program objectives
  • Communicate objectives to line management
  • Drive and lead execution of global clinical programs
  • Oversee, review, and deliver quality program CAPAs
  • Ensure CAPAs meet corporate compliance and timelines
  • Provide expert leadership for program budget operations
  • Oversee individual trial budgets and forecasts
  • Ensure adherence to R&D financial standards
  • Review and provide input on clinical trial documents (e.g., protocols, CSRs)
  • Contribute to and review compound level documents (e.g., Investigator Brochures, DSURs, briefing books)
  • Provide guidance and leadership to Global CTLs and cross-functional members
  • Filter, prioritize, analyze, and validate complex information
  • Respond to technical and organizational challenges
  • Support department initiatives and provide input on SOPs, processes, and workstreams
  • Manage large, complex projects
  • Lead diverse project teams
  • Ensure successful project execution and organizational learning
  • Control sizable resources
  • Work independently
  • Define team organization, roles, responsibilities, and budget
  • Contribute to overall program strategic decisions
  • Drive clinical operations strategy within teams
  • Develop innovative clinical operation strategies, including patient access and feasibility plans
  • Serve as subject matter expert for drug development, clinical trial management, regulations, and therapeutic knowledge
  • Lead Clinical Operations Teams
  • Ensure team performance and results
  • Assess and recommend program resource allocations
  • Set team member objectives
  • Coach and develop employees
  • Provide performance appraisal feedback

Berufserfahrung

  • 12 - 15 Jahre

Ausbildung

  • Abgeschlossene BerufsausbildungODER
  • Bachelor-AbschlussODER
  • Master-Abschluss

Sprachen

  • Englischverhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens EMD Serono erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.

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