GSK
Senior Medical Director, Clinical Development - Rheumatology/Immunology
GSK, Collegeville, Pennsylvania, United States, 19426
Overview
Senior Medical Director, Clinical Development - Rheumatology/Immunology role at GSK. Lead clinical and scientific strategies for advanced-stage assets in immunology and fibrosis, shaping treatments for complex diseases. The role provides clinical and scientific leadership for potential new, established, and emerging indications in the immunology and fibrosis portfolio. The Senior Medical Director will work with medicine teams to plan and assure delivery of clinical research and development activities, and with early development teams to plan clinical development programs and enable seamless transition from early to late phase of development. This position requires on-site presence (minimum two days a week) at one of GSK’s US sites (Upper Providence, PA or Waltham, MA). Responsibilities
Lead the end-to-end clinical development strategy for a drug or program. Manage specific clinical development plans for product(s) and/or indication(s) in defined therapy areas. Oversee Integrated Evidence Plan (IEP), Clinical Development Plan (CDP) and its component trials; be accountable for clinical aspects of Target Medicine Profile (TMP). Provide strategic leadership to ensure study designs are aligned with the IEP and CDP, considering scientific rationale, regulatory requirements, product development plan and commercial goals. Establish and deliver clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP. Collaborate with internal teams (Commercial, Research, Regulatory, Clinical Operations, Statistics, etc.) and serve as the clinical point of contact for senior management. Contribute to strategic and organizational initiatives in Clinical Development, including due diligence projects with Business Development activities. Build and manage external relationships with scientific experts to align clinical programs with business strategy and patient needs. Assess and mitigate risks, evaluate technical success probabilities, and identify transformational opportunities with significant patient impact. Contribute to global regulatory submissions and interactions, including briefing documents and responses. Champion implementation of innovative methods and processes within clinical development and promote stakeholder buy-in. Basic Qualifications
Medical degree and clinical medical specialty board qualification in Rheumatology or Allergy/Immunology. Experience in (bio-)pharmaceutical industry with Rheumatology or Immunology clinical drug development. Experience planning clinical development for a Rheumatology or Immunology asset and/or indication. Experience in drug development, including Phase 2 and Phase 3 trial design, initiation, execution, and closure. Experience with global regulatory filings/submissions. Experience with immunologic-mediated diseases, underlying biology, and potential therapeutic targets. Preferred Qualifications
Deep experience in Rheumatology, Autoimmune, or Neuroinflammation space. Solid understanding of needs and priorities of regulators, payers, and prescribers in relevant global markets. Experience collaborating with multiple stakeholders on complex projects. Proven ability to build and maintain strong relationships with internal and external stakeholders. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, including pregnancy, gender identity, sexual orientation, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law. If you require accommodation to apply for a job at GSK, please contact the GSK Service Centre for assistance.
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Senior Medical Director, Clinical Development - Rheumatology/Immunology role at GSK. Lead clinical and scientific strategies for advanced-stage assets in immunology and fibrosis, shaping treatments for complex diseases. The role provides clinical and scientific leadership for potential new, established, and emerging indications in the immunology and fibrosis portfolio. The Senior Medical Director will work with medicine teams to plan and assure delivery of clinical research and development activities, and with early development teams to plan clinical development programs and enable seamless transition from early to late phase of development. This position requires on-site presence (minimum two days a week) at one of GSK’s US sites (Upper Providence, PA or Waltham, MA). Responsibilities
Lead the end-to-end clinical development strategy for a drug or program. Manage specific clinical development plans for product(s) and/or indication(s) in defined therapy areas. Oversee Integrated Evidence Plan (IEP), Clinical Development Plan (CDP) and its component trials; be accountable for clinical aspects of Target Medicine Profile (TMP). Provide strategic leadership to ensure study designs are aligned with the IEP and CDP, considering scientific rationale, regulatory requirements, product development plan and commercial goals. Establish and deliver clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP. Collaborate with internal teams (Commercial, Research, Regulatory, Clinical Operations, Statistics, etc.) and serve as the clinical point of contact for senior management. Contribute to strategic and organizational initiatives in Clinical Development, including due diligence projects with Business Development activities. Build and manage external relationships with scientific experts to align clinical programs with business strategy and patient needs. Assess and mitigate risks, evaluate technical success probabilities, and identify transformational opportunities with significant patient impact. Contribute to global regulatory submissions and interactions, including briefing documents and responses. Champion implementation of innovative methods and processes within clinical development and promote stakeholder buy-in. Basic Qualifications
Medical degree and clinical medical specialty board qualification in Rheumatology or Allergy/Immunology. Experience in (bio-)pharmaceutical industry with Rheumatology or Immunology clinical drug development. Experience planning clinical development for a Rheumatology or Immunology asset and/or indication. Experience in drug development, including Phase 2 and Phase 3 trial design, initiation, execution, and closure. Experience with global regulatory filings/submissions. Experience with immunologic-mediated diseases, underlying biology, and potential therapeutic targets. Preferred Qualifications
Deep experience in Rheumatology, Autoimmune, or Neuroinflammation space. Solid understanding of needs and priorities of regulators, payers, and prescribers in relevant global markets. Experience collaborating with multiple stakeholders on complex projects. Proven ability to build and maintain strong relationships with internal and external stakeholders. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, including pregnancy, gender identity, sexual orientation, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law. If you require accommodation to apply for a job at GSK, please contact the GSK Service Centre for assistance.
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