Director, Clinical Research and Early Programmes Immunology

3 weeks ago

Durham, North Carolina, United States GlaxoSmithKline Full time
Site Name: UK - Hertfordshire - Stevenage, Belgium-Wavre, UK - London - Brentford, USA - Massachusetts - Waltham, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence
Posted Date: Apr

A Director, Clinical Research and Early Programmes Immunology is sought to provide clinical and scientific insights to the immunology franchise including emerging indications and adjacencies . You will work with in project teams to plan and assure delivery of clinical research and development activities. You will work with early and late development teams to plan clinical development programs and facilitate close collaboration between different groups within the Respiratory & Inflammation Research Unit.

The responsibilities of the Director Clinical Research and Early Programmes Immunology include (but are not limited to) several key areas:
  • designing and leading , as appropriate , clinical development protocols / studies/ programs in Immunology across all phases of development , as required by business imperatives as part of clinical and medicine development matrix teams.
  • accountability for study Ph1-2/3 design
  • providing clinical expert input into regulatory documentation and leading regu latory interactions from clinical perspective for their studies/ indications, as appropriate
  • working closely with R esearch Unit members to define prioritised clinical indication s for early target s and integrate inputs from across disciplines (scientific, clinical , commercial, regulatory and stats ) to contribute to the Medicine Profile, Target Validation , Translational Plans , Candidate Selection . , clinical development plan and integrated evidence pla n
  • a ccountab ility for design and delivery of an earl y clinical development plan that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile to support progression to full development
  • And/or accountability for design and delivery of the full development clinical development plan that effectively demonstrates benefit-risk and leads to a successful submission to regulators, payors etc
  • accountability for leading the integrated evidence planning to address the needs of regulators, payors and patients
  • participating/ l ead ing the c linical Team (CT) (or equivalent cross-functional clinical team) and Integrated Evidence Team (IE T)
  • a ccounta bility for engaging external academic and clinical experts to enhance quality and delivery of clinical programmes / studies
  • a ccountab ility, if medically qualified , for Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across all studies and other GSK activities/functions impacting safety and efficacy ( i.e., manufacturing, formulation, etc.)
  • a ccountab ility, if medically qualified , for providing medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study and, together with the Safety Pharmacovigilance Physician, providing input into aspects of study design that relate to subject safety
  • a ccountability for providing clinical input into presentations, supporting documentation for and participation in the governance bodies presentations, as requested
  • a ccountab ility for escalation of clinical safety incidents to the Immunology Clinical Research and Early Programs Head and GSK Pharmacovigilance, as appropriate
  • accountability for clinical input to regulatory documentation to support the desired indication (e.g., IB, IMPD)
  • responsibility for addressing clinical questions at meetings with regulatory authorities/ethics committees
  • a ccountab ility for regulatory reporting requirements including Development Safety Update Reports (DSUR's) and IB updates
  • a ccountab ility for incorporating patient perspective in the design and conduct of clinical studies


Leadership
  • You will be experienced in drug development and/ or translational medicine , preferably with industry experience
  • You will be expected to work across multiple projects and be independently accountable for your own projects
  • You will be expected to input into disease area strategy and be capable of executing this strategy based on your own expertise and that gained from your network
  • You will play a leadership role in - medical governance initiatives in R&D ( e.g., safety panel or governance board) - discovery/development policy, processes or guid elines, as requested by the business - or in professional networks in/outside of GSK
  • You will be able to input into relevant business development activities representing , as requested
  • You will be able to be mentoring and coaching other members of Clinical Research and Early Programmes Immunology - applying extensive knowledge of clinical development to more than one research unit/disease area
  • You will be able to build an external network with academia/pharma, bringing expertise back to GSK
  • You will be able to anticipat e , communicat e , and suggest solutions on trends/events outside GSK that affect our business direction - utilizing command of the drug discovery and development process to influence a culture of continuous improvement


Candidate Profile

Basic Qualifications:
  • Doctor of Medicine OR ' MD, PhD ' OR PhD with industr y experience
  • S ignificant proven clinical or scientific e xpertise in rheumatology/dermatology/immunology


Qualifications & Preferable Expertise

In addition to the above, the following will be highly desirable:
  • Specialty training in rheumatology /dermatology/ immunology area, in particular lupus and adjacencies , would be a dvantageous
  • Industry experience in translational medicine and early /late phase drug development ; e xperience of setting and executing scientific strategy, whilst being mindful of overall company goals
  • Understanding and knowledge of early /late drug development and translational sciences
  • Experience in working with relevant regulatory bodies and professionals in early / late stage discovery and development
  • Project Management
  • Demonstrates the discipline of risk-based planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time-based metrics.


We're excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we're building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it'll be one of the healthiest workplaces in the world, with best-in-class tech and bright, light spaces to help us thrive.

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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Important notice to Employment businesses/ Agencies

GSK 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 GSK's Transparency Reporting For the Record site.

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