Senior Clinical Development Director - Clinical Research Immunology

Company: Disability Solutions
Location: Collegeville
Posted on: March 27, 2025

Job Description:

Site Name: USA - Pennsylvania - Upper Providence, GSK HQ, Stevenage, USA - Massachusetts - WalthamPosted Date: Feb 11 2025Position Overview: We are seeking a dynamic and experienced Senior Director Clinical Lead for Immunology to lead our clinical development programs within the Immunology therapeutic area. This role will involve strategic oversight, leadership, and management of programmes and clinical trials, ensuring scientific integrity and adherence to regulatory requirements.Key Responsibilities:

• Provide strategic leadership and direction for the design, execution, and management to clinical development plans and clinical trials in Immunology.
• 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 specific therapy/disease areas.
• Contribute to the strategic management of the Integrated Evidence Plan (IEP), including oversight of the Clinical Development Plan (CDP) and its component clinical trials for an asset in development. Be accountable for the clinical components of the Target Medicine Profile (TMP).
• Oversee the development and implementation of clinical trial protocols, ensuring alignment with regulatory requirements and GSK's scientific standards.
• Collaborate with cross-functional teams, including research, regulatory affairs, medical affairs, and commercial teams, to ensure cohesive and comprehensive clinical development plans.
• Serve as the primary point of contact for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators.
• Ensure the integrity, safety, and efficacy of clinical trials through rigorous monitoring, data analysis, and risk management.
• Lead and mentor clinical professionals, fostering a culture of innovation, collaboration, and excellence.
• Stay abreast of advancements in Rheumatology research, clinical trial methodologies, and regulatory changes to maintain GSK's competitive edge.
• Contribute to above asset Immunology strategy.
• Assist in clinical evaluation of business development opportunities.
• Represent GSK in scientific meetings, conferences, and industry forums to advance our Immunology clinical research initiatives.
• An on-site office presence (minimum of two days a week) is required in one of GSK's UK (London - New Oxford Street or Stevenage) or US (PA or MA) offices.Basic Qualifications:
  • PhD with experience in Immunology and Rheumatology
  • Experience in the pharmaceutical/biotechnology industry and/or clinical academic medicine in the field of Immunology. Minimum of 5 years of experience clinical research and development, with a focus on Immunology/Rheumatology or related therapeutic areas.
  • Experience with planning clinical development for an asset and/or indication. Proven record of delivery of clinical trials and projects.
  • Experience of clinical research methodology and principles of biostatistics to facilitate innovative and efficient designs of clinical trials and clinical development plans with clear data-driven decision rules.
  • Regulatory experience to support product registration and GCP principles
  • Experience of global regulatory filings/submission
  • Experience of leading and managing clinical trials.
  • Understanding of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research.Preferred Qualifications:
    • Experience (minimum 3 years) working with global regulatory agencies and managing global clinical trials in Rheumatology.
    • Leadership/People Management experience in clinical practice, academia and/or industry.
    • Robust knowledge of Rheumatology-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution.
    • Leadership of a global clinical development program in the biopharmaceutical industry.*LI-GSKWhat We Offer:
      • Competitive salary and comprehensive benefits package.
      • Opportunities for professional growth and development within a leading global healthcare company.
      • A collaborative and inclusive work environment that values diversity and innovation.
      • The chance to make a significant impact on the advancement of Immunology treatments and improve patients' lives.Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Keywords: Disability Solutions, Lower Merion , Senior Clinical Development Director - Clinical Research Immunology, Executive , Collegeville, Pennsylvania