Senior Director, Clinical Lead
3 months ago
A Senior Director, Clinical Lead is sought to provide clinical and scientific support for potential new, established, and emerging indications for a late stage, 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 consider 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) 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 and files, 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 produce business solutions.
Basic Qualifications:
Bachelor of Science
Experience in (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 filings/submission
Line/matrix management experience including also coaching, mentoring and development, with a record of inspiring and motivating high-performance team.
Preferred Qualifications:
MSc, PhD, PharmD or Medical Degree preferred
If Physician, specialist training or board qualification/eligibility (or having completed the comparable level of post-medical school clinical training)
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 collaborating with multiple stakeholders on complex projects.
Record of building and maintaining strong relationships with internal and external stakeholders
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.
#LI-DNI
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.
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