Clinical Lead, Strategic Planning JAPAC
Innovative Neuroscience and Immunology Focused Global Pharmaceutical
Drive Strategic Clinical Development Planning and Execution across APAC
- Innovative European biopharmaceutical company focused on development of advanced therapeutics in CNS and Immunology areas
- Be responsible for overall implementation of the CDP to ensure timelines, budget as well as deliverables are within expectation.
- Co-author and/or review protocol concept / protocol, other study-related clinical documents according to the CDP, and scientific publications.
- Ensure that medical science is well incorporated into the clinical development strategy, plans and study designs.
Guide the team through data analyses and review to conclude for study result interpretation.
- Serve as the leader in logic construction in clinical for various submissions across the region, such as CTD/eCTDs, CTAs/CTNs and NDAs or IDLs.
- Support to establish "Center of Excellence" in clinical development in Asia.
- Lead the Development Team, including but not limited to: stakeholder management, team alignment, team meeting and communication, team goal setup and deliverable status check, collaborate with other project teams such as EDT, JCST, ST.
- Work with the team and stakeholders to develop CDP for the region/country.
- Contemplate study design for each clinical trial and prepare study concept according to the CDP.
- Ensure the best medical science parts are incorporated into the CDP of the assigned clinical program/projects, including study design discussion, protocol concept / protocol development, and other related documents.
- Oversee the ongoing evaluation of study efficacy/safety and data quality, effectively and efficiently interact with partners, key opinion leaders and investigators.
- Drive the implementation of the CDP for timeline, budget and deliverables; provide technical guidance to the operational team when needed; identify potential risks and manage any challenges that may occur.
- Lead the team in data analyses and result interpretation for studies.
- Main responsible person at meetings with Regulatory Authorities and/or partners as necessary.
- Main responsible person at conferences and meetings with Key Opinion Leaders as necessary.
- Ensure compliance of program/project(s) with all appropriate regulations, SOPs, company processes and ICH-GCP and quality standard applicable to company.
- Construct the submission logic for clinical part of CTD/eCTD and any other regulatory documents.
- Lead and drive clinical part of submission team to establish quickest time from LPLV to NDA.
- *Understand and apply scientific principles to clinical development strategy / trial design as well as data acquisition, analyses, and reporting. Apply fair balance in data interpretation.
- Depending on previous professional experience, more than 3 years of relevant experience in biopharmaceutical-clinical development (or equivalent) is required including the following:
- Oversight of the planning and simultaneous management and reporting of multiple clinical studies.
- Broad experience in writing and/or participation in the preparation of submission documents required (across or at timepoints along the continuum from original protocol to NDA/PLA to safety updates).
- Experience in critical review of relevant development and regulatory documents outside the clinical arena preferred.
- Current knowledge of most aspects of the global clinical development processes / global studies required.
- The knowledge of relevant therapeutic area preferred.
- Actual experiences for authorities' consultation, authorities' review and negotiation processes to obtain approval are also preferable
- Work at a regional level (across JAPAC region)
- Contribute to development of innovative neuroscience and immunology products