The position leads the global clinical development of early and late stage development assets within the portfolio of the Therapeutic Area as well as post-market activities, in alignment with the wider R&D and commercial strategies, to meet the target product profile.
Leading one or multiple cross-functional “Clinical Development Teams” (CDTs) in a matrix organization, the position drives the development activities throughout the lifecycle of the compound from the definition of the clinical development and clinical trial strategies up through to the submission to health authorities for market approval, in alignment with the CDTL responsible for the compound. It further works closely with the commercial function on post-marked clinical activities.
The position holder is a member of the Clinical Development Leadership Team (CDTL) for the Therapeutic Area.
Major responsibilities:
In close alignment with the CDTL responsible for the compound, lead the design and execution of the cross-functional clinical development strategy for designated compound(s) to meet the target product profile/quality standards, obtain regulatory approval, demonstrate value and achieve target reimbursement
Lead the ongoing adjustment and optimization of the clinical development strategy along the lifecycle of the compound, factoring in clinical/medical, financial, policy, regulatory and any other relevant external factors, in order to maximize the full potential of the asset.
Organize and lead the “Clinical Development Team” (CDT) - in a matrix organization including functional representatives from Commercial, Market Access, Clinical Science, Regulatory Affairs, Technical Operations, Program Management, Quantitative Sciences, and Legal - to drive the compound’s clinical development activities and enable an effective strategy planning and decision-making process.
Represent the CDT towards senior leadership and in governance bodies within PHTA (CDLT, APLT) and in the wider R&D organization (Development Committee, Investment Committee, etc.) in order to achieve strategic alignment and approval for the clinical development activities
Proactively anticipate strategic and operational risks to the programs, address these to the relevant functional stakeholders, and ensure their mitigation or resolution
Champion the product at all levels of the organization, while bringing the wider portfolio perspective and R&D and Commercial strategies to the CDT.
Contribute to the professional development of CDT members, proving feedback, coaching and suggesting personal development actions
Ensure robust and strategically aligned publications, IIS, clinical trial and RWE initiatives globally
Support regulatory submission activities in order to obtain regulatory approval.
Drive and maintain external alliances for partnered products.