Global Clinical Program Director

hace 2 días

Girona, Gerona, España Almirall A tiempo completo
Job Title: Global Clinical Program Lead

Job Summary:

The Global Clinical Program Lead will be responsible for leading the strategic clinical team within Global Clinical Development, working cross-functionally with other R&D and non-R&D departments. This role requires strong analysis, synthesis, and communication skills, with a good level of autonomy.

Key Responsibilities:
  • Define the clinical development strategy, milestones, and resources required to meet development decision points and target product profiles.
  • Plan and implement Phase 2 and 3 studies, as well as dose-finding and pivotal studies enabling regulatory approval.
  • Provide clinical/medical leadership within internal cross-functional teams for assigned assets, as well as joint clinical/cross-functional teams in case of development/market partnerships.
  • Represent Global Clinical Development at internal meetings and committees, and serve as the primary contact for Global Medical Affairs, Market Access, and Marketing to define needs and clinical differentiation strategy.
  • Provide clinical/medical guidance to Clinical Study Teams to ensure alignment of clinical trials conduct and planning with overall development strategy.
  • Lead the design, delivery, and interpretation of clinical studies results, ensuring ethical and scientific integrity in compliance with GCP.
  • Review and approve key clinical trial documents, such as protocols, SAPs, and CSRs.
  • Ensure internal and external peer review of study/program design.
  • Analyze and present clinical trial results as required (internal/external committees).
  • Responsible for clinical/medical overview/content of study synopsis, protocol, amendments, CSRs, ICFs, CRFs, protocol deviation decisions, and other clinical documents.
  • Lead scientific meetings/advisory boards with subject matter experts/key opinion leaders to ensure robust clinical development plan and study designs to maximize product value and data generation.
  • Represent Global Clinical Development at meetings with Health Authorities and other external stakeholders.
  • Lead/support study-specific committees (IDMC, steering committee, adjudication committee).
  • Ensure clinical review/oversight of potential due diligences during evaluation of external opportunities, presenting and defending conclusions to appropriate decision-making committees.
Requirements:
  • Medical degree; specialty in dermatology is a plus.
  • Advanced degree (PhD or master's degree in Pharmaceutical Medicine) is valuable.
  • Demonstrated clinical research expertise in Dermatology/Immunology preferred but not required.
  • At least 3 years of Pharmaceutical Industry experience in drug development.
  • Demonstrates understanding of methodology in the design, conduct, review, and interpretation, and presentation of clinical research.
  • Significant hands-on clinical drug development experience and scientific credibility. Experience in early-stage or late-stage development preferred.
  • Fluency in English (written and spoken), proficiency with MS Office.
Skills and Competencies:
  • Data analysis, communication, and high presentations skills in team settings and in formal presentations to leadership committees both internally and externally.
  • Strategic leadership skills with the ability to influence others and drive consensus building.
  • Proven teamwork and collaboration skills.
  • Analytical and problem-solving mindset.
Values:
  • Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
  • Courage: we challenge the status quo, we take full ownership and we learn from our success & failures.
  • Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
  • Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.

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