RHO

  • Senior Nonclinical Research Scientist

    Job Location US-NC-Durham
    ID
    2019-1456
    Type
    Regular Full-Time
  • Overview

    Rho is currently looking for a Senior Nonclinical Research Scientist who will provide strategic and tactical leadership to projects and teams by developing viable and long-lasting solutions to cross-program, cross-functional, and organizational issues and initiatives.

    Responsibilities

    • Serves as Rho’s nonclinical product development expert, responsible for the full range of nonclinical product development activities and services required to support the integrated product development programs and regulatory submissions of Rho’s clients, including gap analyses, strategic planning, executing and reporting of nonclinical studies, and authorship and review of regulatory submissions
    • Leads the nonclinical/preclinical and related regulatory components of integrated product development programs
    • Provides leadership, guidance, and support to a team, program, or project of large scope, as well as to the Program Management discipline within the company
    • Mentors and advises staff in nonclinical product development by providing strategic and tactical guidance to team members, creating a strong sense of team unity and team identity, and providing regular and ongoing positive and corrective feedback to team members
    • Proactively identifies risks and critically analyzes problems affecting the programs
    • Develops contingency plans as needed
    • Facilitates achievement of strategic goals for a program
    • Monitors ongoing progress of key nonclinical deliverables against Global Integrated Product Development Plan goals, including the identification of potential risks and contingency plans
    • Ensures effective, accurate and timely communication of key issues and progress to the team and Sr. Management
    • Manages the nonclinical components of regulatory submissions projects including INDs, IMPDs, IDEs, NDAs, BLAs, MAAs, and PMAs or portions thereof and is comfortable with all requirements related to electronic submissions
    • Manages scope of work, budget, and timelines for external nonclinical vendors, including consultants, preclinical toxicology houses, laboratories, and other vendors as appropriate
    • Participates in the planning, preparation, and conduct of regulatory authority meetings, and leads nonclinical discussions with regulatory authorities as appropriate
    • Plans, conducts, and/or leads nonclinical facilities qualification assessments, audits, and mock inspections.
    • Participates in business development activities, including assisting in the identification and assessment of new opportunities, representing Rho at conferences and meetings, and conducting capture activities for anticipated proposals
    • Provides guidance and input to the budgets and business submissions of proposals
    • Mentors other technical leads in business development and proposal creation activities

    Qualifications

    • PhD in Toxicology or related Life Sciences field, or equivalent demonstration of analytical ability, and 8+ years of relevant nonclinical product development and regulatory experience (DABT certification is desirable)
    • Experience with FDA is required; experience with ex-US regulatory authorities (meetings, submissions, strategy) desired
    • Excellent written, verbal, and interpersonal communication skills and the ability to interact effectively with all levels both within and outside the company
    • Proven ability to establish credibility with professionals on program teams
    • Excellent regulatory intuition and project management acumen
    • Ability to understand and motivate others and build effective teams
    • Ability to proactively develop and foster constructive interactions among team members in order to address difficult situations, including resolving and negotiating conflicts or problems with tact, diplomacy, and composure
    • Excellent presentation and critical thinking skills
    • Ability to handle multiple projects and priorities with exceptional organizational and time management skills (both project and self)
    • Proficient in advanced techniques with relevant software: MS Project, Visio, Excel, PowerPoint, Word, etc. in addition to experience working within shared work environments
    • Ability to travel as needed

    EOE. Veterans/Disabled

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