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Palo Alto

    Associate Director, Oncology Clinical Science - Palo Alto, United States - Ascendis Pharma A/S

    Ascendis Pharma A/S
    Ascendis Pharma A/S Palo Alto, United States

    3 weeks ago

    Default job background
    Description
    This role is involved in the design, monitoring, and data analysis of the Company's oncology clinical trials. As such, the Associate Director, Oncology Clinical Scientist is an important and visible member of the Oncology team.
    Key Responsibilities
    Provide input to protocol design, provide oversight of clinical data (entry by sites, data completeness/accuracy working closely with ClinOps/Biometrics/Data Management teams), and support site and subject retention in clinical trials alongside the Medical Monitor(s)
    Develop and maintain up to date slide presentations for internal meetings related to the clinical trial(s)
    Ensure successful completion of documents (including protocols, investigator brochure, safety monitoring plan, site training materials, clinical study report, health authority responses, standard operating procedures, etc.) with cross-functional team members
    Represent Clinical Development on study teams and cross-functional teams as appropriate or as delegated by the Medical Monitor(s)
    Ensure consistent use of language and criteria across multiple oncology projects (including partner studies)
    Ensure study integrity and track accumulating clinical data in real time
    Analyse, evaluate, and support accurate interpretation and reporting of clinical data
    Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance
    Able to mentor and manage clinical scientists or interns (assigned as direct reports) within Clinical Development
    Collaborate with—and serve as a clinical research resource for—cross-functional colleagues to optimize product development
    Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders to represent the interests of the company
    Contribute to corporate strategic and organizational initiatives
    Complete assigned tasks thoroughly, accurately, and on time
    Adhere to rigorous ethical standards
    Travel up to 20% domestically and internationally for scientific meetings
    Knowledge, Skills and Experience
    Advanced degree e.g. Ph.
    D., Pharm.
    D., equivalent OR at least 8 years of relevant work with direct involvement in clinical trials
    Strong track record of scientific and clinical inquiry
    Understand statistical concepts and clinical trial design
    Possess excellent communication skills (both written and verbal)
    Learn quickly, follow complex directions under pressure
    Multi-task while remaining organized and attentive to detail
    Work hard, be a trustworthy and collaborative team player
    Take initiative and solve problems of moderate complexity
    Demonstrate sound judgement in terms of handling complex, confidential, and regulated information
    Lead both directly and by example
    At least 5 years of experience with clinical trial design and execution
    At least 5 years of pharmaceutical industry experience
    Experience with regulatory submissions and interactions preferred
    Estimated compensation K/year DOE
    Medical insurance
    Vision insurance
    Dental insurance
    401(k)
    Paid maternity leave
    Paid paternity leave
    Commuter benefits
    Disability insurance

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