Has and maintains deep scientific, technical and clinical expertise in the specific therapeutic area
Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest
Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
Maintains visibility within the therapeutic area to maintain credibility with internal and external stakeholders
Oversees development planning, execution and budget
Owns the overall program strategy and leads the international cross functional team to meet program objectives
Participates in life cycle management strategy planning in collaboration with marketing teams
Proposes strategies for interactions with health authorities
Establishes project goals in alignment with functional resource allocation, goals and objectives
Responsible for generating support and implementation of clinical studies
Ensures operational plans are integrated across all functions
Responsible for annual budget deliverables
Ensures that team members are adequately qualified and trained in the task they are required to perform. Including accountability and maintaining compliance training for direct reports
Works cross functionally to select appropriate team members
Sets team’s objectives, and works closely with direct reports to create individual performance and development goals
Ensures clinical data meets all necessary regulatory standards
Supports registrations, label submissions and modifications
Manages Advisory Committee preparation and participation
Scientific data dissemination
Ensures timely submission and dissemination of clinical data
Supports the planning of advisory board meetings
Establishes and maintains appropriate collaborations with knowledge experts
Job Requirements:
Strong scientific and academic background with deep understanding of the disease
Experience in or demonstrated evidence for the capacity to lead and manage groups of professionals
Strong leadership skills to manage international, cross-functional teams of highly skilled professionals
Good networking ability in cross-cultural environment.
Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
In depth knowledge of global drug development activities including the development of other health care solutions along the whole value chain from research up to market access. Skilled in project and/or budget/resource management
Strategic thinking in combination with understanding science and technologies
Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills
Medical Doctor
Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME)
More than 5 years of clinical or scientific, or more than >10 years industry, experience within the field of the specific therapeutic area compounds
Fluent in English (verbal and written communication)
