Senior/ Group Clinical Development Director, Immunology - Open to flexible working

Location
Brentford, Stevenage
Salary
£Competitive
Posted
28 Jun 2022
Closes
28 Jul 2022
Ref
324866
Contract Type
Permanent

Are you energized by the opportunity to lead global drug development programs, build on new technologies, such as Artificial Intelligence/ Machine Learning (AI/ML) for understanding autoimmune diseases and potential therapies, and drive accelerated business performance to bring new treatments to patients? If so, consider exploring this opportunity.

A Senior/Group Clinical Development Director is sought to provide clinical and scientific support for potentially additional and established indications for belimumab and emerging indications for other early and late stage assets in the immunology portfolio. As Senior /Group Clinical Development Director, you will lead an important new initiative to apply AI/ML methods to autoimmune diseases and therapies, building on GSK’s rich clinical trial datasets. You will work with project teams to plan and assure delivery of clinical research and development activities. You will work late development teams to plan clinical development programs and also facilitate close collaboration between Research and Development. You will have direct line management responsibilities, and will also lead senior clinicians and  clinical scientists in a matrix role.

Job purpose and key responsibilities:

  • Lead matrix team of senior clinicians and clinical scientists with responsibilities for various clinical development programs. Support technical and leadership development of Clinical Sciences staff via direct line management, mentoring and coaching.
  • Develop vision and lead exploration of extensive data from clinical trials in autoimmune diseases, including but not limited to, SLE, in collaboration with experts in AI/ML, biostatistics, and biomarkers. Identify opportunities for expanding this program to include other datasets, as warranted.
  • Identify and highlight acceleration, innovation and transformational opportunities where projects can offer highly significant benefit to patients.
  • Champion implementation of innovative methods and processes within clinical development and gain stakeholder support; encourage others to think differently and come up with business solutions. Oversee the strategic management of the Integrated Evidence Plan (IEP), including oversight of the Clinical Development Plan (CDP) and its component clinical trials for those assets in development under your leadership. Provide strategic leadership in designing the CDPs and IEPs, and then, for example in assuring that clinical study protocol designs are aligned with the IEP and CDP, and take into account the scientific rationale, regulatory requirements, product development plan and commercial goals.
  • Develop and maintain relationships with corporate counterparts in Commercial, Early Development, Research, Regulatory Affairs, Clinical Operations, Biostatistics and other groups.
  • Oversee clinical aspects of Business Development activities, including due diligence projects.
  • Serve as a clinical point of contact for senior management and senior level matrix teams.
  • Interface with and influence a range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs that align to business strategy and address patient needs
  • Identify and highlight acceleration and value-finding opportunities where projects can offer highly significant benefit to patients.
  • Assess risk/benefit at the study and/or project level. Take action to mitigate risk where appropriate.
  • Make substantial contributions to regulatory interactions, including briefing documents, presentations, submission documents, and responses to questions.

Why you?

Basic Qualifications:

  •  MD or PhD or PharmD degree
  • Significant industry experience in clinical drug development, including leading preparation of submission documents to regulatory authorities for approval of a new drug or indication, preferably in Immunology.
  • Experience with leading and driving clinical development for an asset and/or indication. Proven record of delivery of clinical trials and projects.Knowledge of clinical research methodology and principles of biostatistics to facilitate accelerated. innovative and efficient designs of clinical trials and clinical development plans with clear data-driven decision rules
  • Line management, coaching, mentoring and development experience. Experience leading line and matrix teams with a track record of inspiring and motivating high performance
  • Strong leadership skills, with proven ability to inspire high performance from cross-functional teams
  • Track record of building and maintaining strong relationships with internal and external stakeholders
  • Robust knowledge of ICH and GCP guidelines, regulatory and reimbursement data requirements
  • Solid understanding of needs and priorities of regulators, payers and prescribers in relevant market(s)
  • Immunology previous experience and expertise

Preferred Qualifications:

  • Post-graduate qualification valuable

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and speciality medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.​

With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.​

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers.  As a candidate for a role, we want you to feel the same way.

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 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.

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.

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