Job Title: Global Clinical Program Lead (GCPL)
The Global Clinical Program Lead (GCPL) is a key member of the Global Project Team, leading the Strategic Clinical Team within Global Clinical Development. This role involves working cross-functionally with departments such as Regulatory, Patient Safety, Disease Biology, Global Market Access and Pricing, Medical Affairs, Marketing, Market Companies, and Business Development.
The GCPL is responsible for the benefit-risk evaluation of clinical assets, providing clinical and medical leadership, and overseeing the implementation of clinical development plans for assigned projects. The role demands strong analytical, synthesis, and communication skills, with a good level of autonomy.
Tasks & Responsibilities
- Define clinical development strategies, milestones, and resource requirements in collaboration with cross-functional teams.
- Plan and execute Phase 2 and 3 studies, including dose-finding and pivotal trials for regulatory approval.
- Provide clinical/medical leadership within internal and joint cross-functional teams for assigned assets.
- Represent Global Clinical Development in internal meetings and committees; serve as the primary contact for Medical Affairs, Market Access, and Marketing.
- Guide Clinical Study Teams to ensure alignment with overall development strategies.
- Design, deliver, and interpret clinical studies, ensuring ethical and scientific integrity in compliance with GCP.
- Review and approve key clinical trial documents such as protocols, SAPs, and CSRs.
- Review ongoing study data and perform benefit-risk evaluations.
- Ensure peer review of study designs and analyze clinical trial results for internal and external presentations.
- Oversee clinical content of study documents, regulatory responses, and publications.
- Lead scientific meetings and advisory boards to optimize clinical development plans.
- Represent the company in interactions with Health Authorities and external stakeholders.
- Lead or support study committees and oversee diligence during external evaluations.
- Chair the Strategic Clinical Teams.
Education & Experience
- Medical degree; dermatology specialty is a plus.
- Advanced degree (PhD or Master’s in Pharmaceutical Medicine) is valuable.
- Experience in clinical research, preferably in Dermatology or Immunology.
- Minimum of 3 years in the pharmaceutical industry involved in drug development.
- Understanding of clinical research methodologies.
- Hands-on experience in drug development and scientific credibility.
- Fluency in English; proficiency in MS Office.
- Strong data analysis, communication, and presentation skills.
- Leadership qualities with the ability to influence and build consensus.
- Proven teamwork and collaboration skills.
- Analytical and problem-solving abilities.
Values
- Care: Empathy, valuing diverse perspectives, and supporting each other.
- Courage: Challenging norms, taking ownership, and learning from experiences.
- Innovation: Centering on patient needs, creating solutions, and empowering entrepreneurial thinking.
- Simplicity: Acting decisively, understanding reasons behind actions, and maintaining agility.