Works hand-in-hand with the Chief Medical Officer to steer clinical strategies and their operationalization in programs and trials.
Drives the operational planning, content, execution and delivery for our programs and studies. Will manage day-to-day clinical activities for our clinical studies including management of protocol amendments, overseeing data review activities and communicating with investigator / sites where appropriate.
Collaborates with other development functions (e.g. Regulatory, Pharmacovigilance, Statistics, etc.) to support clarity on clinical objectives and drives alignment on objectives and expected outcomes
Responsible for trial medical/ safety aspects and risk-benefit assessments.
Develops Risk Management Plans.
Responsible for ongoing medical data review
Ensures on program (where appropriate) and trial level, that the clinical development team works hand-in-hand with Clinical Operations team for patient centric drug development, ensuring balancing of high medical quality, trial complexity, as well as time and cost considerations
Takes ownership together with other partner functions in Development on the acceleration of program and trial design and innovation for the patient
Creates input for clinical sections of key documents, including Investigator's Brochures, IND summary documents, CTAs, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs.
Ensures that the Clinical Study Report (CSR) medical content in assigned programs and trials meets high quality expectations on medical standards, provides respective guidance to other members of the clinical development team
Manages relationships with key external stakeholders (industry partners, Key Opinion Leaders, health authorities).
Represents the team to decision/governance meetings, senior management, or advisory boards as applicable.
Contributes to a collaborate culture within and outside Clinical Development and actively manages best practice sharing and capability building within the clinical team.
