• GlaxoSmithKline PLC
  • $150,470.00 -150,470.00/year*
  • Drexel Hill , PA
  • Healthcare - Physician
  • Full-Time
  • 759 Cornell Ave

Are you looking for an opportunity in Oncology Clinical Development where you can be an integral part of a team supporting preferentially first-in-class transformational drug-candidates that affect the immune system to maximize tumor control and result in increased survival of patients? If so, this is the role for you.

GSK Oncology R&D is focused on building industry-leading portfolios in three cutting-edge areas of science:

  • Immuno-Oncology : Invest to develop differentiated assets and combinations in increasingly crowded IO space.
  • Cancer Epigenetics : Take a more focused approach, pruning some existing assets while maintaining efforts in discovery and clinical development of most promising programs
  • Cell Therapy (CGT): Utilize competitive platform play based on patented technology
  • The Medical Director will be an integral part of the Clinical Team within the GSK Immuno-Oncology (IO) Discovery Performance Unit (DPU). The IO-DPU focuses on the pre-clinical and early clinical development of novel, preferentially first-in-class transformational drug-candidates that affect the immune system to maximize tumor control and result in increased survival of patients. Assets includes ICOS agonist, OX40 agonist, TLR-4 agonist, and other IO agents.

    The Medical Director will be responsible for all aspects related to the clinical development of either a single therapy or combinations.

    In this role, the Medical Director will belong to multi-functional drug development team(s) and will work closely with scientists, statisticians, and other physicians in the discovery and translational medicine groups.

    The Medical Director will be reporting within and managing clinical development team(s) consisting of physicians and clinical scientists, and will provide critical clinical guidance from the selection of a drug candidate to the initial proof-of-concept in clinical trials passing through phase I, II, and pivotal phase IIII, including regulatory filing and registration. The Medical Director will also contribute scientific and medical expertise as well as expertise in clinical trial design insights to the activities of the Clinical Team.

    Responsibilities:

  • Strategic leadership for clinical development plans.
  • Management of critical resources and clinical project timelines.
  • Preparation, design, and/or review of clinical documents, e.g. protocols, investigator s brochures, electronic case report form (e-CRF) design.
  • Immuno-Oncology Clinical Trial Design and optimization.
  • Data optimization and eCRF creation, optimization, and finalization.
  • Participation in interpretation of data analyses of clinical trial results and developing clinical trial reports.
  • Lead preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, etc.).
  • Serve as the Medical Monitor for clinical trials, to address patient eligibility and treatment questions in cooperation with the contract research organization (CRO) or directly with study investigators.
  • Participation in site/investigator identification and evaluation for clinical trials; conduct site initiation and engagement calls and visits.
  • Review safety data for routine medical data review, trend review, and safety signals from ongoing trials.
  • Review adverse event (AE)/ serious adverse event (SAE) reports from ongoing clinical studies and work in close collaboration with GSK safety /the CRO safety team to review causality and develop MedWatch/CIOMS reports (including narratives and analyses of similar events) for reportable SAEs.
  • Serve as program medical expert for internal and external collaborators, investigators, consultants, and contract resources.
  • Represent GSK-Oncology at scientific meetings and presentations.
  • Contribute to scientific affairs by authoring and / or reviewing abstracts, presentations and manuscripts for medical accuracy and content.
  • Attend and provide medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards).
  • Develop and manage relationships with key opinion leaders for clinical programs.
  • *LI-GSK

    Why you?

    Basic Qualifications:

  • M.D.
  • Board certification/eligibility, and clinical experience in oncology or hematology/oncology
  • At least five years pharmaceutical or relevant scientific/medical/clinical experience
  • Experience or interest in experimental cancer-therapeutics especially immune-oncology is an advantageous.
  • Early clinical trial (Phase I and II) or late (phase III) experience in pharmaceutical or biotech industries, or equivalent academic and Clinical Oncology experience especially Immuno-Oncology preferred.
  • Understanding and track record in trial design, conduct, and medical monitoring preferred.
  • Ability to work proactively and effectively applying creative problem-solving skills.
  • Excellent strategic planning, organizational and communication skills.
  • Managerial experience working within or leading high-performance, cross-functional matrix teams.
  • Preferred Qualifications:

  • MD/PhD
  • Why GSK?

    GSK is a science-led global healthcare company that researches and develops and manufactures innovative pharmaceutical medicines, vaccines and consumer healthcare products. GSK currently employs over 100,000 people globally and has offices in more than 115 countries. Our goal is to be one of the world s most innovative, best performing and trusted healthcare companies.

    At GSK, our purpose is to improve the quality of human life by enabling people to do more, feel better, live longer.

    We need a talented, motivated and resilient workforce if we are to deliver against our strategy and tackle global health challenges effectively. To achieve this, we aim to create a working environment where employees feel valued, respected, empowered and inspired.

    About GSK Oncology

    GSK Oncology is committed to the discovery and development of new and potentially life-changing therapies for patients with cancer. Our vision is for people with cancer to not only to live, but to live well, because we are delivering innovative and transformational medicines. We have strictly focused our portfolio on innovation with a focus on the leading edges of science: immuno-oncology, cell therapy and epigenetics. Our deep insight into cancer biology coupled with strategic partnerships will allow us to develop synergistic combinations with transformational potential.

    On December 3, 2018 we announced our agreement to acquire TESARO, an oncology-focused company based in the US. The proposed transaction will significantly strengthen our pharmaceutical business, accelerating the build of our pipeline and commercial capability in oncology.

    If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-###-#### (US Toll Free) or +1 801 ### #### (outside US).

    GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.

    Important notice to Employment businesses/ Agencies

    GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

    Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK s compliance to all federal and state US Transparency requirements. For more information, please visit GSK s Transparency Reporting For the Record site.


    Associated topics: ancmg, breast, hem onc, lah, oncology, palliative, physician md, physician md do, radiation, thedacare

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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