Director Clinical Operations - Gene Therapy in North Quincy, MA US at Apex Systems

    Apex Systems
    North Quincy, MA 02171
    Full-time
    Similar jobs pay $11.00 - $24.52

    Job Description

    Director Clinical Operations, Gene Therapy 1068635

    Job Scope & Purpose:

    Our long-term client, focused in gene therapy is seeking an experienced and motivated Director of Clinical Project Management to be responsible for the planning, implementation, execution, and management of one or more clinical programs/studies. This individual will provide leadership of cross-functional study teams to ensure studies are conducted on time, within budget and with high quality. Additionally, the individual will drive vendor oversight activities to ensure the appropriate transfer, accountability, and execution of delegated tasks.

    Primary Job Responsibilities:
    • Direct and manage cross-functional teams in the planning and execution of clinical programs/studies from study start-up through closeout.
    • Represent Clinical Operations on the Product Development Team (PDT); contribute to the product development strategy, provide operational updates and risk analysis, ensure study teams action on PDT decisions.
    • Collaborate with Program Management and Finance to ensure program timelines and budget forecasts are current and accurate.
    • Conduct ongoing risk assessment and implement contingency plans, as appropriate.
    • Lead and oversee the selection of third-party vendors, including CROs.
    • Work with internal and external stakeholders to optimize patient recruitment and enrollment strategies.
    • Identify and implement opportunities to optimize/enhance processes and or systems to accelerate programs.
    • Participate in the authoring, review, and finalization of clinical documents such as protocols, informed consent forms, clinical study reports (CSRs), pharmacy and surgical manuals, regulatory submissions and other documents as required.
    • Develop and implement plans to ensure inspection readiness and oversee activities in support of GCP audits and regulatory inspections.
    • Participate in the development of SOPs and clinical operational systems.
    • Manage and mentor direct reports.
    Primary Job Requirements:
    • Bachelor's degree in a relevant field and ten (10) years of relevant clinical research experience at a Pharmaceutical or Biotech company or CRO, or
    • Master's degree in a relevant field and eight (8) years of relevant clinical research experience at a Pharmaceutical or Biotech company or CRO.
    • At least five (5) years of relevant experience managing/leading clinical studies, including Phase 2 and Phase 3.
    • At least two (2) years of managerial/supervisory experience.
    About Stratacuity:

    Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

    PROVEN SCIENTIFIC PLACEMENT

    Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

    jprice@stratacuity.com

    Code: ClinOps

    EEO Employer

    Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

    Posting ID: 559413880Posted: 2020-06-03