Global Clinical Lead- Hematology

CSL
  • King of Prussia, PA
    13 days ago

    Job Description

    Reporting to the Head, Global Clinical Development the Global Clinical Lead (GCL) will act in a key leadership role in the Clinical Development (CD) group; 

    • Providing strategic and tactical Medical & Scientific leadership and guidance for clinical development activities for 5-8 Global Clinical Program Leaders (GCPL) 

    • Serving as the CD representative on the Therapeutic Area Leadership team (TALT) for CVR TA 

    • May act as any of the following roles in clinical development: GCPL, Early Clinical Development Lead, Business Development (BD) Contributor, Product Strategy Team (PST) Clinical Representative, Clinical Development Team (CDT) Lead, or a Clinical Study Lead as appropriate for projects as assigned per business need 

    Main Responsibilities and Accountabilities:  

    GCL Line Manager responsibilities include: 

    • Providing strategic and tactical medical leadership and guidance for clinical development activities in for 5-8 GCPLs 
    • Works with other GCLs and head of clinical to ensure adequate resourcing across the portfolio 
    • Manages team of clinical drug developers, acts as a mentor to physician group in guide clinical development expertise in general and in specific areas of therapeutic knowledge 

    GCL TALT CD Representative responsibilities include:  

    • Defining the global clinical development strategy for all projects in TA 
    • Contributing to BD strategy & due diligence for TA & identifies and evaluates NPO’s 
    • Ensuring high quality clinical & scientific content is provided into Regulatory submissions & ensures defense and negotiation with Regulatory agencies 
    • Preparing for stage-gate evaluations and benefit –risk evaluations and assessments 
    • Overseeing and supports the clinical development activity of assigned Clinical Development reports and works in a matrix with CDT leads and Global Project Leaders to ensure optimal clinical strategy, CDP and protocol design to support optimal Project strategy 

     

    GCL Other Responsibilities include: 

    • Be an active member of the Clinical Development Leadership Team, improving the overall quality of the group and its deliverables 
    • Ensuring that the patient and physician voice is at the forefront in strategy development 
    • Building networks with external experts 
    • Driving excellence in clinical development execution 
    • Partnering with TA core, extended core & functional partners to ensure scientific & medically robust clinical dev & med affairs activities 
    • Enhancing the reputation of the Company through thought leadership, KOL interactions in fundamental issues affecting the TA 
    • Representing the Co & TA externally with KOL, Health Technology and external authorities at key forums 
    • Ensuring effective presentations at Scientific and Technical Review Committee 
    • Representing the clinical function on the TALT, responsible for input into TALT strategy, oversee the quality of clinical plans in the CVR TA. 

    Position Qualifications and Experience Requirements:

    • MD, Board Certified (or non-USA equivalent) with relevant sub-specialty highly preferred- if not Board Certified in relevant Subspecialty, then experience in that TA is a must. 
    • Clinical development experience leading a therapeutic area or complex clinical program with a working knowledge of pharmaceutical and regulatory development processes is essential  

    • A minimum of 8-10 years’ experience preferred, acquired in either industry or academic positions, although the latter would also require experience in working with industry sponsors 

    • Outstanding influencing ability & collaboration skills 

    • Proven leadership experience 

    • Ability to work effectively in a matrix environment that includes interactions with multiple stakeholder groups; particularly demonstrated ability to work across the critical interfaces between Clinical and non-Clinical functions 

    • Experience interacting with Health Authorities and designing programs that meet the needs of HA’s, commercial and payers 

    Numbers & Facts

    LocationKing of Prussia, PA

    Skills

    • Business Developmentunmatched
    • Clinical Supportunmatched
    • Clinical Trialunmatched
    • Drug Developmentunmatched
    • Due Diligenceunmatched
    • Healthcare Qualityunmatched
    • Hematologyunmatched
    • Leadershipunmatched
    • Mentoringunmatched
    • Negotiation Skillsunmatched
    • Product Strategyunmatched
    • Project Developmentunmatched
    • Protocol Designunmatched
    • Quality Managementunmatched
    • Regulationsunmatched
    • Regulatory Submissionsunmatched
    • Reporting Skillsunmatched
    • Resource Managementunmatched
    • Risk Analysisunmatched
    • Strategic Planningunmatched
    • Team Lead/Managerunmatched
    • Team Playerunmatched
    • Thought Leadershipunmatched
    • User Documentationunmatched

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