• Job Description

  Req#: 380264

  GSK site preferred locations: Durham, NC, Upper Providence – Collegeville, PA, GSK House.

  On-site presence of 2-3 days per week on average is required.

  ** New GSK UK Headquarters - move from GSK House, Brentford **

  We’re moving towards a more sustainable future with our new headquarters. With better public transport links and proximity to world-class science and technology institutions, we’re excited for our move to the vicinity of Earnshaw Street, London WC1A (“the New HQ”) by end H1 2024.

  At GSK we focus on what matters most to our people, this means managers helping employees to be themselves, feel good and keep growing, in ways that work for them. If you're energized by the opportunity to partner with key leaders in global drug development to drive and accelerate business performance to bring new treatments to patients, this opportunity is for you.

  A Clinical Development Director is sought for our respiratory portfolio. As Clinical Development Director, you will lead the design and implementation of studies from the scientific perspective at multiple stages of drug development and will be a key contributor to clinical research and development activities.

  Job purpose and key responsibilities:

  • Generating the data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe

  • Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery

  • Contributing to regulatory interactions including clinical trial applications, briefing documents, presentations, addressing questions and responses

  • Contributing to the writing of the clinical study synopsis (CSP), study protocols, clinical study reports (CSR) and any subsequent study abstract and manuscript publications

  • Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development

  • Ensuring alignment with and support to project strategic plans, regulatory requirements and commercial goals, optimizing clinical study design aligned with IEP and CDP

  • Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP

  • Developing and maintaining relationships with matrix counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.

  • Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset in development

  • Interfacing and influencing a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs and align to business strategy and address patient needs

  • Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Sciences

  • Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches

  Why you?

  Basic Qualifications:

  We are looking for professionals with these required skills to achieve our goals:

  • Bachelor’s degree in a science related field

  • Clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.

  • Knowledge of ICH guidelines, GCP, FDA requirements, regulatory and reimbursement data requirements in responsible area

  • Experience using new learning and digital tools to create innovation in other areas

  • Experience in clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules

  • Experience integrating genetic data to inform and guide clinical protocols

  • Experience utilizing statistics, and visualisation techniques to interpret or analyse complex information and make correct inferences and conclusions.

  Preferred Qualifications:

  If you have the following characteristics, it would be a plus:

  • PhD or PharmD degree valuable but not required

  • Experience leading matrix teams with a strong reputation of inspiring and motivating high performance

  • Previous experience as a Clinical science Lead (CSL) at GSK, or a similar position in another company

  • Significant experience in respiratory clinical drug development with an understanding of the disease area, the underlying biology and potential therapeutic targets.

  Why GSK?

  We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

  In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

  Find out more:

  Our approach to R&D .

  #LI-GSK

  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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

  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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

  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/ 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.

• About the company

  GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, England.

Notice