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Vp, Pharma Clinical Program Delivery

10+ years
preferred by company
10 Nov. 22, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences/BBA/MBA/phd 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: Vice President of Pharma Clinical Program Delivery
Site Locations:

  • UK – London – New Oxford Street
  • Belgium
  • Canada - Ontario - Mississauga
  • Greater Poland
  • India - Karnataka - Bengaluru
  • UK - Hertfordshire - Stevenage
  • USA - Pennsylvania - Upper Providence
  • Warsaw
     

Job Overview:

The Vice President (VP) of Pharma Clinical Program Delivery will be a key member of the Clinical Operations Leadership Team, contributing to the overall strategy of Clinical Operations (ClinOps) and governance decisions for new medicines. The VP will lead a global team and be accountable for the operational delivery of the entire end-to-end Pharma clinical portfolio, ensuring the achievement of key clinical development plan progression targets from design to submission.

This role will involve collaboration with internal and external stakeholders, including the Research Unit leadership teams, MDLs/EDLs, Clinical Sciences, Supply Chain, Regulatory, ClinOps functions, and senior leaders, to optimize the operational delivery of development plans and accelerate cycle times. The VP will also enhance relationships with strategic partners to improve delivery, productivity, and vendor performance.


Key Responsibilities:

  • Strategic Leadership: Provide strategic leadership and single-point accountability for the global delivery of Pharma Clinical Program Delivery, ensuring alignment with stakeholders and meeting progression targets.

  • Team Leadership: Lead a large, global, cross-functional team of clinical professionals. Oversee training, performance management, career development, and deployment of staff to projects, ensuring business requirements are met.

  • Protocol Optimization: Drive innovative approaches to optimize protocols, accelerate recruitment, and reduce amendments before FSFV. Focus on speeding up study start-up cycle times and enhancing overall development timelines.

  • CRO Excellence: Implement the principles of Contract Research Organization (CRO) excellence to enhance productivity and quality with strategic partners.

  • Collaboration Across Teams: Enable close collaboration between clinical scientists, MDLs, medical writers, and other stakeholders to complete key strategy documents (e.g., briefing books, CTD/NDA) and ensure timely, high-quality submissions.

  • Clinical Sourcing Strategy: Own and assess the enterprise clinical sourcing strategy. Reassess strategic partners regularly to ensure alignment with the future pipeline and organizational needs.

  • Clinical Planning: Embed clinical planning as a core capability within asset lead and SDL communities, ensuring optimized plans and clear mitigation strategies.

  • Culture Development: Foster a culture of best practice sharing, community building, talent development, innovation, and problem-solving. Encourage collaboration across the development organization to deliver the portfolio and define key performance metrics.

  • Quality Management: Stay informed on quality trends and issues related to clinical trials. Take a holistic approach to Corrective and Preventive Action (CAPA) development and implementation.

  • Regulatory Inspection Readiness: Support regulatory authority inspection readiness across the entire R&D pharma and franchise clinical portfolios.


Basic Qualifications:

  • Education: Bachelor’s degree in Sciences or Business.
  • Experience:
    • Leading global, multidisciplinary, functional, line, and matrix teams.
    • Establishing and executing a strategic vision for a global function.
    • Clinical operations experience, including study/asset leadership, data, and site management.
    • Therapeutic area expertise in oncology, respiratory, and inflammation.
    • Experience in driving transformation across organizational changes, digital upgrades, and accelerating operational processes.

Preferred Qualifications:

  • Education: Master’s degree or PhD.
  • Skills:
    • Ability to simplify and understand complex situations.
    • Project management skills/experience.
    • Effective communication, negotiation, and presentation skills at senior organizational levels.
    • Collaborative mindset.

This role offers a unique opportunity for a strategic leader to influence global clinical program delivery, optimize processes, and drive innovation in clinical trial execution. The VP will be instrumental in shaping the future of Pharma clinical development at GSK, contributing to the success of groundbreaking therapies.