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Senior Manager - Medical Affairs Interventional Studies, Speciality & General Medicine

5+ years
Not Disclosed
10 Jan. 16, 2025
Job Description
Job Type: Full Time 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: Senior Manager - Medical Affairs Interventional Studies, Specialty & General Medicine
Location: USA - Pennsylvania - Upper Providence, UK – London – New Oxford Street
Posted Date: Jan 15, 2025

GSK is a global healthcare company committed to improving the quality of human life by enabling people to do more, feel better, and live longer. We discover, develop, and deliver innovative medicines, vaccines, and consumer healthcare products, all while dedicated to helping people worldwide.

At GSK, we foster an inclusive and diverse workplace that reflects the communities we serve. We offer competitive compensation and benefits, professional development opportunities, and a culture centered on innovation, collaboration, and integrity.

Position Overview:
The Senior Manager - Medical Affairs Interventional Studies, Specialty & General Medicine is responsible for overseeing the execution of a program of sponsored clinical trials by the medical affairs organization. This role requires expertise in industry-sponsored clinical research, global medical affairs, and cross-functional team management. The Senior Manager will ensure that all interventional studies are conducted to the highest quality, ethical, and operational standards, leveraging the latest clinical trial innovations, including digital health, to drive GSK’s pipeline of therapeutics. This individual will work collaboratively with the Global Medical Affairs therapy area teams and clinical operations & Biostatistics organizations to execute the program.

Key Responsibilities:

  • Operational Management: Oversee the operational aspects of medical affairs interventional studies, including planning, budgeting, resource allocation, and timeline management. Collaborate with cross-functional teams and third-party vendors to ensure seamless execution and delivery.

  • Regulatory and Compliance: Ensure studies comply with GCP and other relevant regulatory guidelines. Oversee regulatory submissions and interactions related to interventional studies and ensure quality control for clinical trials.

  • Stakeholder Engagement: Serve as the primary contact for internal and external stakeholders. Collaborate with key opinion leaders, investigators, and external partners to enhance study design and execution. Communicate study progress and challenges to senior leadership.

  • Innovation and Continuous Improvement: Identify and implement innovative approaches to improve the efficiency and effectiveness of interventional studies. Stay up to date on industry trends, emerging technologies, and new methodologies in clinical research.

Basic Qualifications:

  • Advanced degree in a relevant scientific discipline (MD, PhD, PharmD, or equivalent).
  • 5+ years of experience managing large-scale interventional clinical trials.
  • 5+ years in clinical research, including study set-up and informing treatment guidelines.
  • Experience in supporting Clinical Development work and managing operational aspects of medical affairs studies.
  • Work experience in therapeutic areas like Oncology, Specialty Care, General Medicine, or Respiratory.
  • Familiarity with regulatory requirements, GCP, and clinical research standards.

Preferred Qualifications:

  • Strong leadership, communication, and interpersonal skills.
  • Excellent problem-solving abilities.
  • Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities.

Why GSK?
At GSK, we unite science, technology, and talent to get ahead of disease together. Our company’s mission is to positively impact global health, deliver sustainable shareholder returns, and create an environment where people can thrive. If you share our ambition and desire to make a difference, we invite you to join us in this exciting journey.

GSK is an Equal Opportunity Employer. We value diversity and encourage individuals from all backgrounds to apply. We provide equal consideration for employment without regard to race, gender, sexual orientation, disability, and other protected characteristics.

For more information about GSK US Benefits, please visit the GSK US Benefits Summary page.