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    Director-Clinical Development, Ophthalmology ( Remote)

    Exegenesis Bio Inc
    1-4 years
    $76,900 to $104,800 per year
    Remote, USA
    10 Nov. 14, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Director - Clinical Development, Ophthalmology
    Reports to: CEO
    Location: Remote
    Exempt/Non-Exempt: Exempt
    Direct Reports: No
    Department: Clinical Science

    Job Summary:
    The Director of Clinical Development, Ophthalmology, is responsible for driving clinical development strategies and execution for investigational and/or marketed products in the Ophthalmology Therapeutic Area (TA). The role includes providing critical input into the development, management, and execution of Phase 1-4 clinical studies, while collaborating with the Clinical Operations team and offering medical expertise in the clinical development plan.

    Essential Job Functions:

    • Clinical Development Expertise & Strategy:

      • Lead clinical scientific strategy for Exegenesis Bio’s Ophthalmology programs.
      • Develop study protocol synopsis, perform benefit/risk analysis for clinical protocols, and ensure protocol validation and amendments.
      • Build relationships with principal investigators (PIs), key opinion leaders (KOLs), and thought leaders to enhance drug development and clinical trial design.
      • Stay informed about the latest scientific advancements and regulatory issues within the Ophthalmology field.

    • Medical Monitoring:

      • Oversee medical data review during trials, including eligibility and ongoing medical review.
      • Lead medical interactions at clinical trial sites, providing training and addressing protocol requirements, safety management, and drug mechanisms.
      • Assess key safety-related adverse events and collaborate with Worldwide Patient Safety.
      • Ensure GCP and compliance obligations are met throughout the clinical process.

    • Health Authority Interactions & Publications:

      • Serve as a medical expert in key Health Authority interactions and advisory board meetings.
      • Contribute to clinical content for Clinical Study Reports (CSRs), regulatory filings, and briefing documents.

    Job Requirements:

    • Experience / Education:

      • Bachelor’s degree in a related scientific field required; US board-certified or eligible (or foreign-equivalent) MD strongly preferred.
      • Minimum of 3 years in clinical medicine and 3 years in drug development or biomedical research, preferably with Ophthalmology experience (gene therapy experience is a plus but not required).

    • Knowledge / Skills / Abilities:

      • Expertise in clinical trials, including statistical principles, medical monitoring, and GCP/ICH Guidelines.
      • Familiarity with US FDA and EMEA regulations, with experience in FDA interactions essential.
      • Proven success in managing Phase I-IV clinical studies, trial design, IND submissions, and marketing approval filings.
      • Strong communication skills with investigators, KOLs, and regulatory agencies.
      • Ability to lead cross-functional teams and develop strategic growth plans.
      • Flexibility to work in a fast-paced environment and handle large data volumes.

    • Travel Requirements: Ability to travel up to 25% as needed.

    About the Company:
    Exegenesis Bio is a clinical-stage global cell and gene therapy company focused on developing innovative genetic medicines. The company, founded in 2019 with strong financial backing, has a pipeline targeting therapeutic areas such as CNS, ophthalmology, and liver. With locations in Philadelphia, Boston, China, and Singapore, Exegenesis aims to increase access to gene and cell therapies worldwide.

    Benefits:

    • Medical, Dental, Vision Insurance and FSA
    • Generous Paid Time Off (PTO), including vacation, sick time, and national holidays
    • 401(k) match and annual company contribution
    • Company-paid life insurance, AD&D, and LTD
    • Employee wellness program and gym reimbursement
    • Annual corporate bonus and quarterly sales incentives for eligible positions
    • Long-term incentive plan for eligible positions
    • Referral bonus program

    Equal Opportunity Employer:
    Exegenesis Bio is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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