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- Tasks: Lead clinical development programs in Immunology, ensuring scientific integrity and regulatory compliance.
- Company: GSK is a global biopharma company focused on advancing health through science and technology.
- Benefits: Enjoy a competitive salary, comprehensive benefits, and opportunities for professional growth.
- Why this job: Make a significant impact on Immunology treatments while working in a collaborative and inclusive environment.
- Qualifications: PhD in Immunology with 5+ years of clinical research experience required.
- Other info: On-site presence required at GSK offices in the UK or US for at least two days a week.
The predicted salary is between 72000 - 108000 £ per year.
Site Name: USA – Pennsylvania – Upper Providence, GSK HQ, Stevenage, USA – Massachusetts – Waltham
Posted Date: Feb 11 2025
Position 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 in 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.
What 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.
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.
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.
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Senior Clinical Development Director - Clinical Research Immunology employer: GlaxoSmithKline
Contact Detail:
GlaxoSmithKline Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Clinical Development Director - Clinical Research Immunology
✨Tip Number 1
Make sure to stay updated on the latest advancements in Immunology and Rheumatology. This knowledge will not only help you during interviews but also demonstrate your commitment to the field and your ability to lead innovative clinical development programs.
✨Tip Number 2
Network with professionals in the Immunology space, especially those who have experience with global regulatory agencies. Building these connections can provide valuable insights and potentially lead to referrals for the position.
✨Tip Number 3
Prepare to discuss your previous experiences in leading clinical trials and managing cross-functional teams. Highlight specific examples where you successfully navigated challenges, as this will showcase your leadership skills and strategic thinking.
✨Tip Number 4
Familiarize yourself with GSK's current Immunology projects and their Integrated Evidence Plan (IEP). Understanding their strategic direction will allow you to align your vision with theirs and demonstrate how you can contribute to their goals.
We think you need these skills to ace Senior Clinical Development Director - Clinical Research Immunology
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Senior Clinical Development Director position. Understand the key responsibilities and qualifications required, especially in Immunology and clinical trial management.
Tailor Your CV: Customize your CV to highlight relevant experience in clinical research, particularly in Immunology and Rheumatology. Emphasize your leadership roles and any successful clinical trials you have managed.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for Immunology and your strategic vision for clinical development. Mention specific experiences that align with GSK's goals and how you can contribute to their mission.
Highlight Regulatory Experience: Since regulatory knowledge is crucial for this role, make sure to detail your experience with global regulatory agencies and any successful submissions or filings you've been involved in.
How to prepare for a job interview at GlaxoSmithKline
✨Showcase Your Strategic Vision
As a Senior Clinical Development Director, it's crucial to demonstrate your ability to provide strategic leadership. Prepare to discuss your past experiences in designing and executing clinical development plans, particularly in Immunology. Highlight specific examples where your strategic oversight led to successful outcomes.
✨Emphasize Regulatory Knowledge
Given the importance of regulatory compliance in this role, be ready to talk about your experience with global regulatory agencies and submissions. Discuss how you have ensured adherence to Good Clinical Practice (GCP) and other regulatory requirements in your previous projects.
✨Demonstrate Leadership Skills
This position requires strong leadership and people management skills. Prepare to share examples of how you've led and mentored teams in clinical research settings. Focus on how you foster collaboration and innovation among cross-functional teams.
✨Stay Updated on Industry Trends
Show your passion for the field by discussing recent advancements in Immunology and Rheumatology. Be prepared to articulate how these trends can influence clinical trial methodologies and the overall strategy for drug development at GSK.
