Key Responsibilities:
- Works with Business Development Teams to understand future deals and potential impact on Clinical teams
- Provides clinical-related input in to the Transition Services Agreements for divestments or acquisitions.
- Evaluates deal terms and vision / goals and works with the Clinical Development Lead to set up the appropriate clinical transition team to support the deal
- Project manages the clinical transition team or identifies the need for additional PM support and sources this support from the business
- Provides guidance / solutions to teams. Supports definition of scope of work and success criteria
- Collaborates with process and systems teams to ensure all required processes and services are considered fully and that they work in totality and are compatible with GCP, existing standards, processes, systems and services eg. data transfers / data sharing / integration solutions
- Coordinates the clinical data/document management transition activities in divestments and acquisitions
- Partners with Regulatory, Pharmacovigilance, IT leads etc to promote a cross functionally aligned approach to deals and associated post-deal obligations and associated internal organisational activities
- Creates appropriate governance, communication plans, and associated charters for the deal
- Manages clinical relationships in any proposed deal and associated organisational activity and acts as a point of escalation for issues / questions from team members throughout the lifecycle of each deal
- Ensures inspection readiness throughout the lifecycle of the deal
- Manages the DAC toolbox and trains teams in the relevant processes
- Ongoing evaluation of processes and procedures, KPIs, lessons learned etc to feed into continuous improvement of the process and harmonise best practices for future deals
Key Relationships:
Internal:
- Development Operations
- Early & Late TA Organisations â specifically Clinical Development Leads
- Business Development
- Alliance and Integration Management
- IT
- Regulatory, Pharmacovigilance and other functions involved in the deals
- Procurement
External:
- Partner company personnel
- External Vendors (Technology Providers, CROs etc)
Essential Requirements:
- University degree in related discipline, or equivalent
- Significant experience from within the pharmaceutical industry or clinical research organization
- Extensive knowledge of clinical and pharmaceutical drug development process at various phases of development
- Proven leadership skills – promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives
- Demonstrated project management skills with the ability to set and manage priorities, resources, performance targets and project initiatives to deliver to time, cost and quality
- Experience managing clinical transition projects, strategic alliances, and/or collaborations
- Experience of working successfully in an Alliance management role with external partners / vendors
- Experience working with Senior-level stakeholders and cross-functional business partners
- Strong communication, collaboration, networking and interpersonal skills
- Excellent negotiation and influencing skills with a wide range of internal and external stakeholders
Desirable Requirements:
- A high level of cultural sensitivity, interactive communication, negotiation and effective collaboration. This necessitates considerable tact, discretion and persuasion to obtain desired outcomes while maintaining ongoing professional relationships