Role Description
The Clinical Science & External Research (CSER) Associate Director will drive end-to-end evidence generation and dissemination strategies (EGS/EDS). In collaboration with cross-functional teams and research investigators, the CSER Associate Director will generate clinically relevant evidence for the company's innovative pipeline that impact patient lives.
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Leads evidence generation and dissemination strategy for assigned product portfolio, including developing and implementing publication plan
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Leads publication development in partnership with Clinical Research, Biostatistics and physician authors
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Provides critical scientific input to publications
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In partnership with cross-functional teams, develops and implements training and dissemination plans for scientific communication materials
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Handles assigned investigator sponsored studies
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Leads retrospective real-world evidence (RWE) studies including developing study protocol and report for assigned studies
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Provides input to company and investigator sponsored studiesβ protocols as needed
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Develops positive relationships with diverse cross-functional teams including Medical Affairs, Health Economics and Market Access, Global Strategic Marketing, Biostatistics etc. to drive timely project's execution and success
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Leads or participates in monthly literature review with global teams; performs literature review as needed to support evidence generation and dissemination strategies
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Handles budget associated with assigned research and publication projects
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Supports congress planning as needed including clinical booth activities and scientific sessions coverage
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Mentors junior CSER staff as needed
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Responsible for communicating business related issues or opportunities to next management level
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Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
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For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
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Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
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Performs other duties assigned as needed
Qualifications
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A minimum of a Master's Degree with at least 10 years of clinical, medical affairs or related technical experience
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PhD/MD/PharmD with at least 8 years industry/academic research experience preferred
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A minimum of 1-2 year people management related experience is required for this role
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A Life Science, Physical Science, Nursing, or Biological Science degree preferred
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Medical device experience, especially in neurovascular therapeutic experience highly preferred
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Clinical research experience
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Experience with medical writing and systematic literature review desired
Requirements
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Strong scientific capabilities and research background, can think creatively to bring forth new insights and innovative ideas to grow external research collaborations leading to impactful publications
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Able to influence others along with strong written and oral communication skills
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Advanced project management skills with the ability to balance multiple projects
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Strategic mentality and critical analytical skill
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Working knowledge of biostatistical methods
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Successful experience in publication planning and development
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Knowledge of Good Clinical Practices and ICMJE standard
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Leadership in Evidence generation strategy
Benefits
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Vacation β 120 hours per calendar year
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Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado β 48 hours per calendar year; for employees who reside in the State of Washington β 56 hours per calendar year
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Holiday pay, including Floating Holidays β 13 days per calendar year
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Work, Personal and Family Time - up to 40 hours per calendar year
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Parental Leave β 480 hours within one year of the birth/adoption/foster care of a child
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Bereavement Leave β 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
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Caregiver Leave β 80 hours in a 52-week rolling period
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Volunteer Leave β 32 hours per calendar year
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Military Spouse Time-Off β 80 hours per calendar year