Head of Clinical Development – Immunotherapy and Biomarkers

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    POSITION OVERVIEW

    The Vice President of Clinical Development will be responsible for establishing product requirements and development strategies for  Diagnostic Business Unit, while managing the execution of development plans for new and current products.  This important lead role will develop, plan and implement clinical research programs and trials. Lead the team to establish relevant product specification, evidence to support regulatory and payer requirements while addressing unmet clinical needs. The successful candidate will also present technology to key customers including clinical researchers, health care providers, and payers to gain engagement and support.  

    Vice President of Clinical Development will manage the allocation of personnel and financial resources to ensure the successful and timely completion of clinical product development goals.  This pivotal role will coordinate clinical product development with software development to effectively position clinical portfolio for long term success.  This hands-on leader will provide scientific expertise across the organization and drive cross-functional collaboration across all internal stakeholders while working closely with Medical Affairs. 

    RESPONSIBILITIES

    • Provide clinical leadership and focus for R&D to ensure the creation of comprehensive product development plans from concept to launch 
    • Develop actionable plans with anticipate regulatory requirements and timelines to support validation and labeling efforts 
    • Provide timely product development requirements to operations which will support scaling infrastructure and capacity to support new product/market needs.  
    • Experience writing and implementing research protocols, reviewing and interpreting data, preparation of study reports, data analysis and presentation of data to internal and external audiences.
    • Ability to work in a matrix environment with other departments to include Project Management, Regulatory Affairs and Medical Affairs.
    • Excellent oral, written and personal communication skills.
    • Strong clinical research, leadership and management experience
    • Demonstrated experience leading collaborations with RA, QA, R&D, Medical and Commercial to successful product launch.  
    • Define and manage external partnership(s) including face to face meeting with global thought leaders
    • Interact with therapeutic partners to inform appropriate product requirements 
    • Serve as subject matter expert across the clinical portfolio to support business objectives
    • Expert communication of data in presentations at scientific conferences, either local, regional, or international
    • Create, support, present medical and scientific educational content supporting strategic plans
    • Exemplifies transparency and promotes quality of science
    • Liaise with Business Development and research functions to maximize the scope of new product development plans

    REQUIRED SKILLS, ABILITIES AND CREDENTIALS

    • Advanced degree in Life Sciences: PhD, MD, or MD PhD 
    • Strong technical background in molecular biology, genomics, next generation sequencing
    • >7 years of experience leading IVD and CLIA product development
    • Research experience in hematology, oncology or immunology with a demonstrated understanding of clinical trials addressing diagnosis, treatment of disease
    • Understanding of running clinical trials from study concept to publication
    • Excellent leadership experience in a matrix environment
    • Effective communication skills
    • Good interpersonal relationship building/maintenance
    • Ability to establish relationships and high-level customers
    • Strong presentation skills are very important
    • Excited about an early stage company environment that may require greater self-sufficiency.
    • Travel is required

please email CV to jobs@tseworldwide.com