- Leading the definition and delivery of an integrated asset strategy throughout the lifecycle maximizing the value of the asset/program(s) or group of programs, consistent with corporate & portfolio strategy in partnership with functional experts from research, translational, regulatory, clinical, manufacturing, medical affairs, IP, communication, quality (compliance) and commercial.
- Leading the program and program team to achieve the objectives in accordance with quality standards and within timelines validated with governance.
- Ensures oversight of the Program budget in partnership with functional heads who are accountable for delivery within budget.
- Responsible for all activities related to the program(s) are conducted:
o Within the framework of the agreed asset strategy and the overall strategic objectives of the Company
o With cross-functional alignment of Research, non-clinical & clinical, Manufacturing & Commercial, IP, communication, quality (compliance) representatives
o In compliance with the state-of-the-art and external regulations in force, and good project management practices.
At all phases of planning and implementation, ensures appropriate validation by and reporting to governance according to company processes. Owns the integrated strategy for the asset. Is responsible for ensuring the validation of integrated development plan by key stakeholders (senior management/stakeholders and external experts/customers). Ensures cross-functional engagement / way of working to ensure full team alignment and utilizing every member of the team to execute the program strategy. Responsible for the robust assessment of opportunities, risks, in conjunction with the key function leaders, in order to maximize value of the asset/program. Responsible for setting up backup scenarios, as well as « go/no go decision points » to mitigate risks and to present them to Governance meetings. Develops and recommends strategic options to governance. Responsible for appropriate internal communication to Program team and stakeholders. Contributes to and adopts relevant aspects of the company’s portfolio management process. Engages in regular, competent and active communication with key stakeholders as a representative of the company both internally and externally (congress, partnering, and negotiation). Defines & implements Program internal & external communication plans:
o Proposing and conducting communications concerning the results of both scientific and clinical studies in association with the cross-functional team.
o Ensuring consistency across Program messages for external communication.
o Owns all Program Documents relating to the development of the drug candidate as required by Governance, Quality, Compliance & PMO guidance.
Key program deliverables, developed with cross-functional expert team, include:
o Integrated cross-functional development strategy, objectives & plan, consistently with Target Product Profiles & key value drivers.
o Status Updates for Management e.g. dashboards, reports, highlights at governance, other.
o Program Risks/opportunities and mitigation plans.
o Key Decision Points documentation.
Contributes to key functional Project documentation & deliverables as required by governance, Quality, compliance & PMO guidance, such as the Clinical trial documents, IND file, investigator's brochure, Briefing Documents, scientific publications, scientific collaborations work plans, documentation to support CDMO key decision points, documentation for HA interactions, etc.
