Senior Director, Clinical Lead
6 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.
-
Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full timeJob OverviewGSK is a global biopharma company with a mission to unite science, technology and talent to get ahead of disease together. We are seeking an experienced Senior Nephrology Clinical Development Director to join our team in the UK.Salary Range:£120,000 - £180,000 per annum, depending on experience.About the RoleWe are looking for a highly skilled...
-
Senior Clinical Research Director
1 week ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeAbout the RoleWe are seeking an experienced Senior Clinical Research Director to lead our Oncology Therapeutic Area team at GSK. As a key member of our clinical development team, you will be responsible for providing strategic clinical input during protocol development, overseeing study conduct, and interpreting study results.
-
Clinical Development Director Lead
2 days ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeJob OverviewThe Clinical Development Director opportunity at GSK offers a unique chance to partner with key leaders in global medical science to accelerate business performance across the organization. This role is ideal for professionals seeking a challenging position that drives global operational support.
-
Senior Clinical Nurse Leader
1 week ago
Stevenage, Hertfordshire, United Kingdom Ramsay Health Care Clinical Full timeAbout the RoleWe are seeking an experienced Senior General Nurse to join our Pre Assessment team at Rivers Hospital in Stevenage, Hertfordshire. As a Senior Staff Nurse, you will be responsible for delivering high-quality clinical outcomes and providing exceptional patient care.ResponsibilitiesCurrent NMC registrationPrevious experience working within Pre...
-
Clinical Development Director
4 weeks ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeJob Title: Clinical Development DirectorWe are seeking a highly skilled Clinical Development Director to join our team at GSK. As a key member of our clinical development organization, you will be responsible for leading the development of clinical studies, ensuring the highest quality and integrity of data collection, and providing medical governance for...
-
Operations Director for Clinical Assets
7 days ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeClinical Operations DirectorThe Clinical Operations Director will lead the development and implementation of operational strategies for clinical assets at GSK. This role requires a deep understanding of clinical research project management, quality requirements, and processes.Key Responsibilities:Developing and implementing operational strategies for...
-
Stevenage, Hertfordshire, United Kingdom GSK Full timeUnlock Your Potential in a High-Impact Senior Leadership RoleAbout the OpportunityGSK is seeking an experienced and innovative Executive Director Clinical Interface to lead our R&D Clinical Supply Management for Medicines and Vaccines. As a key member of our leadership team, you will drive strategic initiatives and collaborate with senior leaders across...
-
Stevenage, Hertfordshire, United Kingdom GSK Full timeAbout GSKGSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty and general medicines.Our AmbitionWe are driven by a passion to innovate and improve the lives of patients around the world. Our success depends on our people –...
-
Clinical Development Director
4 weeks ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeClinical Development Director - Nephrology Job DescriptionWe are seeking a skilled Clinical Development Director - Nephrology to provide clinical and scientific insights to the Nephrology franchise.This role will involve working within project teams to plan and assure delivery of clinical research and development activities, as well as working closely with...
-
Nephrology Clinical Development Lead
2 weeks ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeClinical Development Director - NephrologyAs a seasoned clinical professional, you will be responsible for providing expert insights to the Nephrology franchise, including emerging indications and adjacencies. Your role will involve working within project teams to plan and assure delivery of clinical research and development activities.Key...
-
Senior Clinical Supply Chain Director
3 days ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeJob Overview">GSK is a global biopharma company committed to unifying science, technology, and talent to get ahead of disease together. As an Executive Director Clinical Interface, you will play a pivotal role in driving scientific innovation across GSK's vaccine and medicine portfolio.">About the Role">The primary purpose of this role is to lead the R&D...
-
Stevenage, Hertfordshire, United Kingdom GSK Full timeUnlock Your Potential as an Oncology Clinical Development LeadEarn a competitive salary of $120,000 - $180,000 per year, depending on experience and qualifications.About the Role:We are seeking an exceptional Medical Director to lead our Oncology Clinical Development team. As a key member of our global biopharma company, you will play a crucial role in...
-
Clinical Director for Immunology Medicines
3 weeks ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeAbout the RoleOverviewAs a Director of Clinical Research and Early Development Immunology at GSK, you will be responsible for providing clinical and scientific insights to the immunology franchise, including emerging indications and adjacencies. You will work within project teams to plan and assure delivery of clinical research and development activities.Key...
-
Global Clinical Innovation Leader
1 week ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeGlobal Clinical Supply Chain DirectorThis role offers a highly visible senior R&D Global Clinical Supply Chain leadership position that will allow you to drive and shape scientific innovation across GSK's vaccine and medicine portfolio.You will lead the R&D Clinical Supply Management for Medicines and Vaccines, delivering optimized demand/supply planning and...
-
Medical Director
1 month ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeJob DescriptionAre you a pharma physician or academic clinician looking to contribute to GSK's growing oncology antibody drug conjugate (ADC) portfolio for the treatment of solid tumors in GI, GU and beyond? This position is a great opportunity to be part of a dynamic team.The PositionThe Medical Director Oncology Clinical Development will report to the...
-
Stevenage, Hertfordshire, United Kingdom GSK Full timeAbout the RoleWe are seeking an experienced Clinical Development Director to join our Nephrology team. This role will play a key part in shaping our clinical development strategy, working closely with research members to define prioritized clinical indications and integrate inputs from across disciplines.ResponsibilitiesDesigning and leading clinical...
-
Stevenage, Hertfordshire, United Kingdom GSK Full timeJob Summary:We are seeking a highly skilled Clinical Development Director to lead our immunology franchise’s clinical development programs. As a key member of our team, you will be responsible for providing clinical and scientific insights to support the development of new treatments for various immunology indications.Responsibilities:Design and Lead...
-
Senior Clinical Pharmacist
2 weeks ago
Stevenage, Hertfordshire, United Kingdom East and North Herts NHS Trust Full timeJob OverviewWe are seeking an experienced Senior Clinical Pharmacist to join our Vascular Surgery Directorate. This is a unique opportunity to lead and deliver a high-quality, proactive, and patient-focused clinical pharmacy service.About UsEast and North Hertfordshire NHS Trust is committed to providing exceptional care to our patients. Our hospitals...
-
(Senior) Clinical QA Specialist
7 months ago
Stevenage, United Kingdom Autolus Ltd Full time**Location**: - StevenageThe (Senior) Clinical Quality Assurance Specialist is responsible for quality oversight activities within Clinical development by supporting and managing cross-functional relationships with business process owners and external stakeholders. Maintains Quality Assurance oversight in Clinical Operations and Clinical Development. This...
-
Clinical Data Analytics Lead
2 weeks ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeGSK Clinical Programming is a collaborative environment where talented professionals engage in advanced data analytics, statistical programming principles, and the development of new computational tools to support innovative research and the creation of novel therapies. Our focus spans six core therapeutic areas: HIV, Immunology, Infectious Diseases,...
