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Senior Director, Clinical Development (Respiratory Clinical Research)

Stevenage

Job Type

Job Function

Medical and Clinical

Location

Stevenage

On-Site or Remote

Job Type

Salary

Competitive salary and benefits

About the Role

*Job description* *Site Name:* UK - London - Brentford, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence *Posted Date:* Jan 26 2024 A Senior Clinical Development Director is sought to provide clinical and scientific support for potential new, established and emerging indications for a late stage, acquired asset in the respiratory portfolio. As Senior Director of Clinical Development, you will work with project teams to plan and assure delivery of clinical research and development activities. You will work with early development teams to plan clinical development programs and establish efficient collaboration throughout all stages of development. *Key responsibilities in details*: - 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). - Provide strategic leadership, for example in assuring that the clinical study designs are aligned with the IEP and CDP, and take into account the scientific rationale, regulatory requirements, product development plan and commercial goals. - Establish and deliver to clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP - Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics. - Serve as a clinical point of contact for senior management and senior level matrix teams. - Contribute to the strategic and organizational initiatives in Clinical Development. - Contribute to Business Development activities, including due diligence projects. - Support technical and leadership development of Clinical Sciences staff via direct line management, mentoring and coaching. - 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 - Lead and be accountable for the evaluation of the probability of technical success (PTS) of clinical studies/programs. - Identify and highlight transformational 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 global regulatory interactions, including briefing documents, presentations, submission documents, and responses to questions. - Champion implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and come up with business solutions *Basic Qualifications:* - Medical Degree with specialist training or board qualification/eligibility (or having completed the comparable level of post-medical school clinical training) - Significant (bio-)pharmaceutical industry experience in clinical drug development - 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 - Experience of global regulatory filing/submission - Line/matrix management experience including also coaching, mentoring and development, with a track record of inspiring and motivating high-performance team *Preferred Qualifications:* In the addition to the above, the following will be highly desirable - Thorough understanding of respiratory diseases, underlying biology and potential therapeutic targets - 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 global market(s) - Experience working collaboratively with multiple stakeholders on complex projects - Track record of building and maintaining strong relationships with internal and external stakeholders *Why Us?* 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 organization 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. 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 Ukdiversity.recruitment@gsk.com or 0808 234 4391. 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. 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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. 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.

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