Consultant Physicians for Saudi Arabia

ISG International Service Group; Salamanca; Presencial; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

Join a forward-thinking company as a Global Clinical Program Lead, where you will spearhead clinical development strategies and collaborate with cross-functional teams. This pivotal role emphasizes leadership and innovation, focusing on the evaluation of clinical assets and overseeing pivotal studies for regulatory approval. You will guide clinical teams, ensuring alignment with development strategies while maintaining the highest ethical standards. If you are passionate about making a difference in the pharmaceutical industry and possess strong analytical and communication skills, this opportunity is perfect for you.

Formación

• Medical degree required; specialty in dermatology is a plus.
• Minimum of 3 years in pharmaceutical drug development.

Responsabilidades

• Define clinical development strategies and milestones for drug development.
• Plan and execute Phase 2 and 3 studies for regulatory approval.
• Represent Global Clinical Development in meetings and committees.

Conocimientos

Analytical Skills

Communication Skills

Leadership Skills

Collaboration Skills

Data Analysis

Educación

Medical Degree

PhD in Pharmaceutical Medicine

Master’s in Pharmaceutical Medicine

Herramientas

MS Office

Descripción del empleo

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 cross-functional collaboration with R&D and non-R&D 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 leadership in clinical development strategy, and overseeing the implementation of clinical plans for assigned projects. The role primarily focuses on early or late-stage development projects, with potential for cross-stage assignments.

Key skills required include strong analytical, synthesis, and communication abilities, along with a high degree of autonomy.

Tasks & Responsibilities

• Define clinical development strategies, milestones, and resource requirements to meet development decision points, Target Product Profile (TPP), Target Product Claims (TPC), and labelling, in collaboration with cross-functional teams.
• Plan and execute Phase 2 and 3 studies, including dose-finding and pivotal studies for regulatory approval.
• Provide clinical and medical leadership within internal and external cross-functional teams for assigned assets.
• Represent Global Clinical Development in meetings and committees; serve as the primary contact for Medical Affairs, Market Access, and Marketing to define clinical differentiation strategies.
• Guide Clinical Study Teams to ensure alignment with overall development strategies.
• Design, deliver, and interpret clinical study results, 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 and program designs and analyze clinical trial results for internal and external presentations.
• Oversee clinical content in study documents and manage clinical meetings and advisory boards to optimize study design and data generation.
• Represent the company in meetings with Health Authorities and external stakeholders, including scientific forums and investigator meetings.
• Support and lead study-specific committees and oversee due diligence processes for external opportunities.
• Lead and chair Strategic Clinical Teams.

Education & Experience

• Medical degree; specialty in dermatology is a plus.
• Advanced degree (PhD or Master’s in Pharmaceutical Medicine) is advantageous.
• Experience in clinical research, preferably in Dermatology or Immunology, is preferred.
• Minimum of 3 years in pharmaceutical drug development.
• Strong understanding of clinical research methodologies, with hands-on experience in drug development.
• Fluency in English; proficiency in MS Office.
• Excellent data analysis, communication, and presentation skills.
• Leadership and collaboration skills, with strategic influence and consensus-building abilities.

Values

• Care: Emphasizing listening, empathy, valuing diversity, and supporting success.
• Courage: Challenging the status quo, ownership, and learning from successes and failures.
• Innovation: Focusing on patient and customer needs, creating novel solutions, and empowering entrepreneurial thinking.
• Simplicity: Acting decisively, avoiding over-analysis, understanding reasons behind actions, and maintaining agility.