Naukrijobs UK
Register
London Jobs
Manchester Jobs
Liverpool Jobs
Nottingham Jobs
Birmingham Jobs
Cambridge Jobs
Glasgow Jobs
Bristol Jobs
Wales Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Sr. Clinical Development Director Future Disease/Genetics

GSK
Job LocationBrentford
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Site Name: UK - London - Brentford, USA - California - San Francisco, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date: Apr 7 2020As a Future Disease Areas Lead/Genetics you will be responsible for leading a group of experts in Specialty Diseases to create a link between Research, Business Development and Clinical Development. This expert will leverage genetics knowledge to inform and help identify promising future transformational medicines and lead strategic reviews for the medicine’s vision and the clinical development strategy for the drug. The expert will engage with external experts as appropriate to leverage best knowledge to inform new disease areas of growth for GSK. Disease areas within Specialty include Neurosciences, Infectious Disease, Rare Disease, Cardiovascular, Metabolic and Renal.This role will provide you the opportunity to lead key activities to progress your career:

  • 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
  • Serves as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset(s) in development
  • Lead and positively interface with and influences 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
  • Integrates 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
  • Assesses and predicts when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit
  • Anticipates 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 youBasic Qualifications: We are looking for professionals with these required skills to achieve our goals:
  • Bachelor’s degree in a science related field
  • Extensive experience in 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: If you have the following characteristics, it would be a plus:
  • MD, PhD or PharmD degree valuable but not requiredSignificant years of experience leading line and matrix teams with a strong reputation of inspiring and motivating high performance</l

    • APPLY NOW

    Sr. Clinical Development Director Future Disease/Genetics Related Jobs

    © 2019 Naukrijobs All Rights Reserved