Lead the clinical R&D department responsible for strategy, design & conduct of all clinical drug programs. Support and ensure fast and efficient development and registration of the assigned portfolio in compliance with applicable laws guidelines and best practices.
Responsibilities include:
*Lead the clinical development department
*Lead operations of clinical trials
*Preparation of study relevant documents for submissions of Biosimilar registrations
*Lead CRO selection process
*Close cooperation with CROs
*Close cooperation with consultants e.g. medical writing, Biostatistics
*Budget responsibility for CRO contracts and all consultant activities within clinical development
*Develop & review health authority documents (briefing documents, IND, aBLA, BLA, CTD and equivalents) and study-related documents such as IB's, CRFs, Protocol, CSRs etc.
*Prepare and host health authorities inspection
*Lead due diligence activities for licensing of new biosimilar candidates with focus on clinical development
*Prepare clinical strategies for new development candidates
*Direct staff to ensure operationยดs efficiency and to ensure that international health authority standards & project goals/timelines are achieved.
*Interact closely with regulatory department, program management and quality department
Requirements:
*Thorough understanding of all phases of global biopharmaceutical drug development in line with EMA and FDA drug development regulations
*Minimum 15 years of relevant experience in all elements of clinical trial design, execution and interpretation of results from phase I to phase IV studies for international registrations
*Demonstrated experience with Biosimilars preferred
*Therapeutic area expertise in immune diseases and ophthalmology as a plus
*Strengths in instructing CRO to perform according to expectations
*Demonstrated success in working with KOLs and PIs
*Thorough knowledge of innovative trial design methods (e.g. statistical modeling, biomarkers, surrogate parameters)
*Experience in negotiations and interaction with health authorities including EMA and FDA; experience PMDA and other authorities of advantage.
*Experienced in medical writing e.g. reviewing & editing briefing books, protocols, INDs and CSRs
*Expertise in GcP and associated SOP system
*Experience in people development, minimum 5 years leading clinical development teams
*Excellent communicator/ability to present, write effective reports, respond to questions from senior management, regulators, KOLs and customers
Impact on organization:
*Personnel responsibility: line management of small to mid- size team
*Financial responsibility: responsibility for assigned clinical program budgets
*Key to ensuring fast and efficient registration of biosimilars through effective cross-departmental coordination
Reports to: Vorstand / CSO
