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- Tasks: Lead clinical development programs in Immunology, overseeing trials and ensuring scientific integrity.
- Company: GSK is a global biopharma company focused on advancing health through innovative treatments.
- Benefits: Enjoy a competitive salary, comprehensive benefits, and opportunities for professional growth.
- Why this job: Make a significant impact on Immunology treatments while thriving 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's UK or US offices for at least two days a week.
The predicted salary is between 72000 - 108000 £ per year.
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Senior Clinical Development Director – Clinical Research Immunology
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 of 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. 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. #J-18808-Ljbffr
Senior Clinical Development Director - Clinical Research Immunology employer: ENGINEERINGUK
Contact Detail:
ENGINEERINGUK 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 highlight your leadership experience in clinical research during networking opportunities. Connect with professionals in the Immunology field through LinkedIn or industry conferences to discuss your background and express your interest in the Senior Clinical Development Director role.
✨Tip Number 2
Stay updated on the latest advancements in Immunology and Rheumatology. This knowledge will not only help you in interviews but also demonstrate your commitment to the field and your ability to contribute to GSK's innovative projects.
✨Tip Number 3
Engage with GSK's current initiatives and publications related to Immunology. Understanding their strategic direction and recent developments can provide valuable talking points during discussions with hiring managers.
✨Tip Number 4
Consider reaching out to current or former employees at GSK to gain insights into the company culture and expectations for the Senior Clinical Development Director role. This can help you tailor your approach and show that you're a great fit for their team.
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: Make sure to detail your experience with regulatory agencies and global clinical trials. This is crucial for the role, so provide examples of how you've navigated regulatory requirements in past projects.
How to prepare for a job interview at ENGINEERINGUK
✨Showcase Your Strategic Vision
As a Senior Clinical Development Director, you'll need 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 Cross-Functional Collaboration
This role requires collaboration with various teams, including research, regulatory affairs, and medical affairs. Be ready to share instances where you successfully worked with cross-functional teams to achieve cohesive clinical development plans. This will show your ability to foster teamwork and communication.
✨Demonstrate Regulatory Knowledge
Given the importance of regulatory compliance in clinical trials, ensure you are well-versed in Good Clinical Practice (GCP) and relevant regulatory requirements. Prepare to discuss your experience with global regulatory filings and how you've navigated complex regulatory landscapes in previous roles.
✨Highlight Leadership and Mentorship Skills
As a leader, your ability to mentor and inspire clinical professionals is crucial. Share examples of how you've led teams, fostered innovation, and created a culture of excellence in your previous positions. This will illustrate your capability to lead and develop talent within the organization.
