Leads activities that include planning content, authoring where appropriate, reviewing and approval of Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents), in support of
Serve as the main contact point to support the local pharmacovigilance responsible person (LPVRP) in the assigned region, where applicable; Support the Head of Regional PV in the harmonization of processes across the regions
Act as a regulatory subject matter expert for ICON. Support initiatives to ensure ICON maintains awareness of new regulatory requirements and opportunities and can deliver services accordingly. Actively contribute to maintaining company awareness of new
Responsible for the development, maintenance and adherence to Genmab’s clinical data standards including eCRFs, edit checks, electronic case report forms (eCRFs) Completion Guidelines, controlled terminology, CDISC, CDASH and etc. The Associate Director
The role is accountable for proactive safety surveillance, signal management, benefit–risk evaluation, and risk mitigation activities, in close partnership with Drug Safety & Pharmacovigilance internal team and cross-functional stakeholders
Leads a team of Clinical Pharmacologist leads, providing strategic direction, leadership, and technical expertise for all aspects of clinical pharmacology studies across the IPSEN portfolio, including small molecules, peptides, and biologics (mAbs, ADCs,
Define and lead the scientific strategy for the therapeutic area, aligned with Evotec’s R&D and business objectives; Identify emerging opportunities based on scientific trends, competitive landscape, and unmet medical needs; Champion the therapeutic