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Sr Clinical Development Director, Respiratory

Employer
GSK
Location
Collegeville, Pennsylvania; Waltham, Massachusetts
Salary
Competitive
Closing date
Jul 8, 2022

View more

Discipline
Health Sciences, Medicine
Job Type
President/CEO/Director/VP
Organization Type
Pharma
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Our R&D approach is focused on bringing together great science, new technologies and outstanding people to make a difference in people's lives. By exploring science related to immunology, infectious disease, and novel therapeutic platforms, , we are focussing on the prevention and treatment of infectious respiratory disease in high-risk individuals. Our expertise has delivered a broad portfolio of novel medicines and treatments for all stages of disease. Our research explores different modalities and mechanisms to seek to help improve time to resolution of symptoms, reduce risk of hospitalization and ICU admission, and reduce the risk of death in people with viral respiratory diseases. Our commitment to harnessing science and the latest technology to address unmet need for respiratory patients is as strong as ever.

We are seeking a Clinical Development Lead for emerging indications and assets in the Respiratory Clinical Sciences Organization. As Senior Clinical Development Director, you will lead life cycle indications in our developing respiratory anti-viral portfolio, including inhaled therapies, novel monoclonal antibodies, and therapeutic vaccines.

Job Purpose and Key Responsibilities:

Providing integrated and innovative clinical development strategy to support the creation and management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development
​ Strategic Leadership :
  • Integrating scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the IEP and CDP
  • 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
  • Establishing expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP
  • Developing and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
  • Contributing to and partnering on the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development
  • Playing an active role in the technical and leadership development of Clinical Sciences staff via coaching and mentoring and potential direct line management

Scientific Leadership, Direction and Strategy:
  • Employs visioning and strategic thinking to provide expert leadership of disease/therapeutic area specific strategy for a drug(s) or program(s). Leads selected clinical development projects for products/franchise of compounds
  • Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset(s) in development
  • Leading and positively interfacing with and influencing across a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver integrated clinical development strategy, which align to the business strategy and achieves mutual goals related to patient need
  • Integrating inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to the Medicine Profile. Accountable for the clinical components of the Medicine Profile.
  • Accountable for risk/benefit of the asset. Actively leads and makes decisions which balance risk/benefit at the project level with clear understanding of impact on study/project indication approvals; takes action to mitigate risk where appropriate
  • Assessing and predicting when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit
  • Anticipating problems and proactively seeks input from other teams' members/functional lines within R&D. Uses scientific/operational expertise to solve study and/or project related problems
  • Accountable for the evaluation of clinical study/program probability of technical success (PTS)

Study & Program Design and Evidence Generation:
  • Drives the end to end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable medicines, and successful lifecycle management
  • Leads clinical development discussions at regulatory interactions and clinical components of the submissions (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses
  • Provides effective leadership support / oversight of evidence generation activities to assure patient safety and study delivery
  • Delivers value and access insights to inform medical strategy, expand market access and to address unmet patient need

Creating Innovative Scientific and Technical Solutions:
  • Overcomes obstacles by experimenting with and adopting new ways of working including digital tools and technology
  • Champions implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and come up with business solutions


Why you?

Basic Qualifications:

  • MD, PhD or PharmD
  • Extensive experience in Respiratory clinical drug development with an understanding of the disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options
  • Extensive clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.
  • Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication
  • Proven ability to maximize and integrate genetic data to advance disease understanding and inform and guide clinical development plans
  • Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules
  • Demonstrated experience using new learning and digital tools to create innovation in other areas
  • Expertise in inductive and deductive reasoning, statistics, and in providing mechanisms to interpret and analyze highly complex information including digital content

Preferred Qualifications:
  • Experience leading line and matrix teams with a strong reputation of inspiring and motivating high performance


Why GSK?

At GSK, we want to find new medicines and vaccines in ways that are faster, more effective and more predictable.

We start with what matters most, the science. Our approach to R&D focuses on science related to the immune system, the use of human genetics, and advanced technologies. Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including oncology, infectious diseases, immunology / respiratory and HIV. We have pivotal study startsin 2021 for our RSV vaccine in older adults, COVID-19 assets, long-acting anti-IL-5 antagonist, daprodustat , and dostarlimab . In oncology, momentum is building with 15 potential medicines in trials, including nine immuno-oncology and three cell therapies.

We give our scientists the freedom to own the process. Our scientists often use genetic data to help us understand the root cause of disease. We steer the research where the data shows we can do most good . If a project doesn't pan out, we take what we've learned and apply it elsewhere.

Technology can help us find patterns in genetic data better and faster. We're using machine learning to unlock the potential of complex genetic data with new levels of speed, precision, and scale. And we're one of the first biopharmaceutical companies to have created an in-house AI lab dedicated to drug development.

Even with the knowledge, tools, and resources within GSK, there's always a benefit to new perspectives. That's why we're increasingly partnering with and hiring outstanding people from cutting edge fields like tech, data-science and academia. In 2018, GSK formed an exclusive, highly innovative collaboration with 23andMe, the world's leading consumer genetics and research company. Other partners include: the Altius Institute; the UK Biobank, which is generating anonymized genetic sequence data from 500,000 volunteers; and the Open Targets Consortium, the mindset and approach of smaller, more agile startups .

#LI-GSK

#LI-Hybrid

Closing date for applications: 30 April 2022

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.

Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email ukdiversity.recruitment@gsk.com

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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