Reporting to the Vice President & Head of Clinical Development, you fill an important leadership role in the Clinical Development group, supporting professional development of a team of Clinical Scientist direct reports, including providing strategic scientific guidance for clinical development activities in projects as assigned. Additionally, you will have Clinical Development program responsibilities including leading or being a line representative to a matrixed Clinical Development Team such as CDT or PST.
Provide strategic scientific guidance for clinical development activities for a team of scientists and ensure consistency of approach, strategy and appropriate oversight of clinical scientist activities supporting multiple, global, Phase 1-4 clinical studies.
Collaborate with other Clinical Scientist Leads, Physician Leads, Clinical PST Representatives, and Global Product Leads (GPLs) to ensure resourcing across the portfolio.
Manage Clinical Development Scientist direct reports, providing guidance, training and mentorship, supporting their long-term career growth.
- Support creation of professional development plans
- Facilitate participation for direct reports in organizational development opportunities including participation in Strategic and Technical Review Committee (STRC), Translational Review Committee, Communities of Practice (CoP), Clinical Development Forum, Technology Forum.
- Guide clinical development activities using expertise in drug development and areas of therapeutic knowledge.
Oversee the clinical development activity of assigned direct reports.
- Support direct reports working within the matrix environment in their interactions with Clinical Delivery Teams (CDT), Biomarker Expert Teams (BET) and Project Strategy Teams (PST) as applicable to complete projects according to the TA Strategy.
- Ensure quality requirements are met for documents including the CDP, STRC presentations, study outlines, clinical protocols, IBs, ICFs, MM plans, IDMC/DSMB/SRC Charters.
Communicate with partners and senior management on resourcing and project related issues. Participate in the hiring and training of new Clinical Scientists. Ensure group budget is adequately planned for, communicated and tracked observing CSL processes.
Promote quality scientific and operational clinical development execution, by collaborating to lead organizational excellence, use lessons learned and identify areas in which we can increase efficiencies; form, develop a group of committed Clinical Scientists, collectively delivering scientifically rigorous and high-quality work to meet the needs of the department.
Participate in project work as a lead clinical scientist or contributing clinical scientist, as applicable, within the CDT by providing high quality clinical and scientific content into the core clinical development documentation and execution of clinical trials.
- Bachelor's degree or equivalent is required.
- An advanced degree (MSc, PhD) in Science, PMP certification, or equivalent is preferred.
- Formal leadership training, including matrix team management is a plus.
- At least 7 years of experience in the biotechnology or pharmaceutical industry (or where relevant a biomedical research organization) is required.
- Recognition and achievements in clinical sciences, document authorship, product research, process development/improvement is required.
- Demonstrated ability and advanced level of experience working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocols and ensuring they meet strategic program goals
- Demonstrated in-depth understanding of the drug development process
- Clinical development experience leading a matrix team or complex clinical program with a working knowledge of pharmaceutical and regulatory development processes
- Clinical development experience in the Cardiovascular and Metabolic disease areas is a plus
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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