Launch Preparation

Developing Post Marketing Pharmacovigilance Systems

Scaling Up of Medical Affairs Capabilities

Planning The Clinical Development Pipeline

Managing Launch Activities Across Functional Groups

Conducting an assessment of the current pharmacovigilance system and activities, identifying short, and long-term recommendations to build towards a sound and effective operating model, and implementing according to plan

Identifying critical Medical Affairs activities to best support the product post-launch, developing a phased strategy and approach for scaling of key Medical Affairs activities (i.e. MSL onboarding, KOL outreach, data generation, congress participation, Medical Information Call Center)

Designing future clinical trials to explain how the company (and its influence on the medical community) will expand in the future, and identifying biostatistical requirements & potential risk areas for current and future trials to ensure data and outcomes are reliable and substantial

Providing strategic, medically and commercially grounded program management to optimize launch activities, identify risks, and ensure that key stakeholders (i.e. Executive Team, Board of Directors, Advocacy Boards) are appropriately aligned and informed

+ Developing Post Marketing Pharmacovigilance Systems

Conducting an assessment of the current pharmacovigilance system and activities, identifying short, and long-term recommendations to build towards a sound and effective operating model, and implementing according to plan

+ Scaling Up of Medical Affairs Capabilities

Identifying critical Medical Affairs activities to best support the product post-launch, developing a phased strategy and approach for scaling of key Medical Affairs activities (i.e. MSL onboarding, KOL outreach, data generation, congress participation, Medical Information Call Center)

+ Planning The Clinical Development Pipeline

Designing future clinical trials to explain how the company (and its influence on the medical community) will expand in the future, and identifying biostatistical requirements & potential risk areas for current and future trials to ensure data and outcomes are reliable and substantial

+ Managing Launch Activities Across Functional Groups

Providing strategic, medically and commercially grounded program management to optimize launch activities, identify risks, and ensure that key stakeholders (i.e. Executive Team, Board of Directors, Advocacy Boards) are appropriately aligned and informed