Senior Director Clinical Lead

3 months ago


Brentford, United Kingdom Lifelancer Full time

A Senior Director Clinical Lead is sought toprovide clinical and scientific support for potential newestablished and emerging indications for a late stage asset in therespiratory portfolio. As Senior Director of Clinical Developmentyou will work with project teams to plan and assure delivery ofclinical research and development activities. You will work withearly development teams to plan clinical development programs andestablish efficient collaboration throughout all stages ofdevelopment.
Key responsibilities indetails:

  • Lead theendtoend clinical development strategy for a drug or program.Manage specific clinical development plans for product(s) and/orindication(s) in specific therapy/diseaseareas.
  • Contribute to the strategic managementof the Integrated Evidence Plan (IEP) including oversight of theClinical Development Plan (CDP) and its component clinical trialsfor an asset in development. Be accountable for the clinicalcomponents of the Target Medicine Profile(TMP).
  • Provide strategic leadership for examplein assuring that the clinical study designs are aligned with theIEP and CDP and consider the scientific rationale regulatoryrequirements product development plan and commercialgoals.
  • Establish and deliver to clinicaldevelopment timelines enabling key decision points and Go/No Gocriteria for the CDP.
  • Develop and maintainrelationships with program counterparts in Commercial ResearchRegulatory Clinical Operations andStatistics.
  • Serve as a clinical point ofcontact for senior management and senior level matrixteams.
  • Contribute to the strategic andorganizational initiatives in ClinicalDevelopment.
  • Contribute to Business Developmentactivities including due diligenceprojects.
  • Support technical and leadershipdevelopment of Clinical Sciences staff via direct line managementmentoring and coaching.
  • Interface with andinfluence a range of scientific external experts (e.g. regulatorspayors CROs consultants investigators) to deliver clinical programsthat align to business strategy and address patientneeds.
  • Lead and be accountable for theevaluation of the probability of technical success (PTS) ofclinical studies/programs.
  • Identify andhighlight transformational opportunities where projects can offerhighly significant benefit to patients.
  • Assessrisk/benefit at the study and/or project level. Take action tomitigate risk where appropriate.
  • Makesubstantial contributions to global regulatory interactions andfiles including briefing documents presentations submissiondocuments and responses to questions.
  • Championimplementation of innovative methods and processes within clinicaldevelopment and gains stakeholder support; encourages others tothink differently and produce businesssolutions.



Whyyou
BasicQualifications:

  • Bachelorof Science
  • Experience in (bio)pharmaceuticalindustry experience in clinical drugdevelopment.
  • Experience with planning clinicaldevelopment for an asset and/or indication. Proven record ofdelivery of clinical trials andprojects.
  • Experience of clinical researchmethodology and principles of biostatistics to facilitateinnovative and efficient designs of clinical trials and clinicaldevelopment plans with clear datadriven decisionrules.
  • Experience of global regulatoryfilings/submission
  • Line/matrix managementexperience including also coaching mentoring and development with arecord of inspiring and motivating highperformanceteam.


PreferredQualifications:

  • MSc PhDPharmD or Medical Degree preferred
  • If Physicianspecialist training or board qualification/eligibility (or havingcompleted the comparable level of postmedical school clinicaltraining)
  • Thorough understanding of respiratorydiseases underlying biology and potential therapeutictargets
  • Robust knowledge of ICH and GCPguidelines regulatory and reimbursement datarequirements
  • Solid understanding of needs andpriorities of regulators payers and prescribers in relevant globalmarket(s)
  • Experience collaborating withmultiple stakeholders on complexprojects.
  • Record of building and maintainingstrong relationships with internal and externalstakeholders

Please usethe below link for job application and quickerresponse.


RemoteWork :

No



  • Brentford, United Kingdom 1925 GlaxoSmithKline LLC Full time

    We’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright,...


  • Brentford, United Kingdom GlaxoSmithKline Full time

    Site Name: Belgium-Wavre, GSK House, Siena Posted Date: Mar 24 2023 Senior Clinical Science Lead (SCSL) Reporting to the Clinical Project Lead (CPL) you will conduct Phase I-IV Clinical Development activities within a large program or group of related programs or, for a mid-size program, to lead Clinical Development activities in order to ensure the high...

  • Associate Director

    2 months ago


    Brentford, United Kingdom SRG Full time

    Role: PET Production Associate Director Job Type: Permanent Location: London (On-site) Salary: Competitive + Bonus, Life Assurance, Private Medical Insurance + flexible benefits SRG is working with a leading CRO that is providing a world class service to Pharmaceutical, Biotechnology and drug discovery organisations supporting the development and...

  • Associate Director

    2 months ago


    Brentford, United Kingdom SRG Full time

    Role: PET Production Associate DirectorJob Type: PermanentLocation: London (On-site)Salary: Competitive + Bonus, Life Assurance, Private Medical Insurance + flexible benefitsSRG is working with a leading CRO that is providing a world class service to Pharmaceutical, Biotechnology and drug discovery organisations supporting the development and clinical...


  • Brentford, United Kingdom City Calling - Recruitment Agency and Jobs in Harr Full time

    Working with a well established residential construction company we are looking for an experienced Construction Sales Director to join their senior management team. With over 13 years industry experience they specialise in new builds, large developments, extensions, conversions and major refurbishments and pride themselves on high-quality work and strong...


  • Brentford, United Kingdom GlaxoSmithKline Full time

    Site Name: Canada - Ontario - Mississauga, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Pennsylvania - Upper Providence, Warsaw, Wavre Posted Date: Apr 4 2023 Global Clinical Development Manager Please note it is your responsibility to notify your manager if you are interested in applying to an open position prior to the interview taking...


  • Brentford, United Kingdom Mandeville Full time

    An established residential and commercial construction company seeks a Sales Director to take their company to the next levelMy client, a vibrant and highly reputable construction company nestled in the heart of West London, is seeking an established and passionate Sales Director to join their team.As the Sales Director, this is what the role will entail :*...


  • Brentford, United Kingdom City Calling Full time

    Working with a well established residential construction company we are looking for an experienced Construction Sales Director to join their senior management team.With over 13 years industry experience they specialise in new builds, large developments, extensions, conversions and major refurbishments and pride themselves on high-quality work and strong...

  • Lead Housekeeper

    3 months ago


    Brentford, United Kingdom Healthshare Group Full time

    Undertake specific cleaning duties when requested. Maintain security within the department. Any other duties commensurate in line with the requirements of the post. Undertaking the day to day cleaning of patient, public and employee areas. Maintaining a safe and pleasant environment for patients, visitors and Healthshare employees. Replenishment of linen...

  • SERM Medical Director

    2 months ago


    Brentford, Greater London, United Kingdom GlaxoSmithKline Full time

    Site Name: UK - London - BrentfordPosted Date: Mar 1 2023Position summaryWho We Are: The ViiV Phase Safety Evaluation and Risk Management (SERM) Group GlobalGlobal Safety is responsible for the collection, processing and regulatory reporting of adverse events experienced by patients receiving GSK products, and for the ongoing safety evaluation and risk...

  • Lead Housekeeper

    3 months ago


    Brentford, United Kingdom Healthshare Group Full time

    Job summary Healthshare is a successfulprovider of clinical and diagnostic services to the private and NHS sectorsacross various locations throughout the country. At Healthshare Clinic WestLondon we have an 8 bedded day surgery unit and theatre complex with 1 theatreand 4 recovery bays, radiology unit, endoscopy unit, 6 consulting rooms and 2minor...

  • Senior Sales Director

    14 hours ago


    Brentford, Greater London, United Kingdom Otis College of Art and Design Full time

    Job Title: Senior Sales Manager, Major ProjectsLocation: GlobalCompany: OtisJob Description:Lead the Sales team to meet targets and drive business growthDevelop and maintain customer relationshipsCreate and implement sales strategiesManage sales team and drive performanceKey Responsibilities:Drive revenue growth through strategic sales planning and...


  • Brentford, United Kingdom GlaxoSmithKline Full time

    Site Name: Belgium-Wavre, Bengaluru Luxor North Tower, Italy - Siena, UK - London - Brentford, USA - Pennsylvania - Upper Providence Posted Date: Mar 13 2023 Job purpose: Apply experience, scientific and operational expertise, and leadership in a matrix organization to provide Medical Writing strategy to one or more Therapy Area assets, the design and...

  • Finance Director

    4 days ago


    Brentford, United Kingdom Harper May Ltd Full time

    Harper May is proud to partner with a dynamic retail company. As the company gears up for exponential growth, they are actively seeking a visionary Finance Director to spearhead their financial strategy and drive operational excellence. About the Company: Our client is a trailblazer in the retail sector, consistently pushing boundaries and setting new...

  • Lead Epidemiologist

    1 week ago


    Brentford, Greater London, United Kingdom 1925 GlaxoSmithKline LLC Full time

    GSK's Epidemiology Department is seeking a highly motivated and experienced Director to lead our efforts in shaping epidemiological strategy and studies across drug development.As a key member of our team, you will play a pivotal role in applying epidemiological expertise to address challenges throughout the drug development lifecycle, from initial discovery...

  • Director of Music

    3 weeks ago


    Brentford, Greater London, United Kingdom Kew House School Full time

    Kew House School was established in the conviction that there exists an opportunity for a different kind of independent secondary school in London – academically demanding but with a forward-thinking approach to selection criteria, the flexibility of the curriculum, the shape of the school day, and recognition of creativity and talent. A...

  • Director of Music

    3 weeks ago


    Brentford, United Kingdom Kew House School Full time

    Kew House School was established in the conviction that there exists an opportunity for a different kind of independent secondary school in London – academically demanding but with a forward-thinking approach to selection criteria, the flexibility of the curriculum, the shape of the school day, and recognition of creativity and talent. A...


  • Brentford, United Kingdom West London NHS Trust Full time

    Job summary Due to recent expansion of psychological provision and exciting developments in our service, we are seeking a passionate and committed clinical or counselling psychologist to join our Mental Health Integrated Network Team (MINT) in Hounslow. MINT is a multidisciplinary service providing holistic support and treatment to adults presenting...


  • Brentford, United Kingdom Sky Group Full time

    Want to do the best work of your life? With 24 million customers in 6 countries, make your mark at Europe's leading media and entertainment brand. A workplace where you can proudly be yourself; our people make Sky a truly exciting and inclusive place to work. The Occupational Health Physician role will be working closely with the rest of the Sky O...

  • Director, Epidemiology

    3 months ago


    Brentford, United Kingdom 1925 GlaxoSmithKline LLC Full time

    Would you like to be part of GSK’s Epidemiology Department, with an opportunity to drive Epidemiology strategy and studies across the spectrum of drug development? If so, this is an excellent opportunity to explore. Our staff in Epidemiology provide leadership and expertise to develop and execute the Epidemiology strategy across the entire spectrum of...