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    Director Clinical Development - Respiratory

    Teva Pharmaceuticals
    2+ years
    Not Disclosed
    Parsippany
    10 Jan. 3, 2025
    Job Description
    Job Type: Full Time Education: MD/DO 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

    Director, Clinical Development - Respiratory
    Location: Parsippany, NJ, USA (Hybrid or Remote)
    Date Posted: December 17, 2024

    Join Teva Pharmaceuticals, a global leader in improving health access and affordability. Teva develops innovative medicines that impact millions of lives daily across nearly 60 countries.

    The Opportunity

    The Director, Clinical Development - Respiratory will oversee the planning, execution, and management of clinical programs worldwide, covering all phases of research. This individual will lead cross-functional teams, provide strategic input, and ensure compliance with regulatory standards. The role requires an ability to work independently in the management of clinical research projects and related documentation, contributing to INDs, NDAs, BLAs, and global filings.

    Key Responsibilities

    • Strategic & Operational Leadership:

      • Serve as a core member of the Global Project Team.
      • Lead the development and execution of multiple Clinical Development Plans.
      • Collaborate with cross-functional teams (Regulatory, CMC, Biostatistics, Marketing, etc.) to ensure successful execution.

    • Clinical & Regulatory Oversight:

      • Ensure compliance with ICH, GCP, and country-specific regulations.
      • Oversee the preparation of key documents, including protocols, Investigator’s Brochures, and clinical study reports.
      • Address safety and clinical issues in consultation with Global Drug Safety and Pharmacovigilance.

    • Stakeholder Engagement:

      • Build and maintain relationships with opinion leaders in respiratory, pulmonary, and atopic diseases.
      • Represent Teva at scientific meetings, advisory boards, and regulatory agency discussions.

    • Documentation & Communication:

      • Author and review clinical documents, including abstracts, manuscripts, and study protocols.
      • Analyze and interpret clinical results to prepare high-quality reports.

    Your Qualifications

    • Education:

      • MD, DO, or equivalent; PhD, PharmD, or DVM with a proven track record may also be considered.

    • Experience:

      • Minimum of 2 years in the pharmaceutical industry or related clinical trial planning/management.
      • Expertise in respiratory, pulmonary, or allergy therapeutic areas is strongly preferred.

    • Skills:

      • Strong interpersonal, verbal, and written communication skills.
      • Ability to manage multiple priorities in a fast-paced environment.
      • Willingness to travel (~30%, domestic and international).

    Work Environment

    This hybrid role requires an on-site presence 3 days a week at Parsippany, NJ or West Chester, PA. Exceptional candidates may be considered for remote work.

    Benefits

    • Health & Wellness:

      • Comprehensive medical, dental, vision, and prescription coverage from Day 1.

    • Financial Security:

      • 401(k) with a 6% match and annual 3.75% Defined Contribution Plan.

    • Work-Life Balance:

      • Paid Time Off, including 13 paid holidays, floating holidays, and vacation days.

    • Additional Perks:

      • Tuition assistance, Employee Assistance Program, life and disability insurance, and more.

    Equal Employment Opportunity

    Teva Pharmaceuticals is committed to fostering an inclusive workplace and providing equal employment opportunities to all qualified individuals.

    Application Process for Current Teva Employees
    Employees are encouraged to apply through the internal Employee Central portal for priority consideration.

    Notice to Employment Agencies
    Teva does not accept unsolicited assistance from agencies without prior written agreements.

    Contribute to groundbreaking respiratory therapies at Teva—apply today to shape the future of medicine!

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