Medical Director - Oncology Clinical Development

    • Collegeville, PA

Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham
Posted Date: Jan 28 2020
Are you interested in a highly visible Oncology Clinical Development role that allows you to shape and be responsible for clinical research activities pertaining to advancing the development of GSK's clinical portfolio while having a leading role in managing effective relationships with Oncology Key Opinion Leaders? If so, this Medical Director role at GSK Oncology R & D could be an ideal opportunity to explore.
GSK's Pharmaceutical Medicines business:
Our pharmaceutical medicines business has a broad portfolio of innovative and established medicines. Currently, we are focusing on developing new medicines in Oncology, Immuno-Inflammation, Respiratory, and HIV/Infectious Diseases. The rebuilding of our Pharmaceuticals pipeline continues with most of our new medicines in development targeting modulation of the immune system. Major progress has been made in our immuno-oncology pipeline with assets now in clinical development, reflecting organic progression, our recent acquisition of Tesaro, Inc., and our new global strategic alliance with Merck KGaA, also known as EMD Serono in the U.S.. (more on the Tesaro acquisition and Merck KGaA alliance below)

Here is some other significant news to be expected in 2019, regarding GSK's multiple new medicines in Oncology, Immuno-inflammation, Respiratory, and HIV/Infectious Diseases:

  • FDA approval decision expected for dolutegravir + lamivudine.
  • FDA filings planned for long-acting injectable cabotegravir + rilpivirine, and fostemsavir for highly treatment-experienced patients.
  • Pivotal stage data readouts expected for BCMA for 4L multiple myeloma, Zejula for 1L maintenance ovarian cancer, and PD1 dostarlimab for endometrial cancer.
  • Updated phase I PFS data from DREAMM-1 study for BCMA to be published in leading journal.
  • Phase III start planned for anti-GMCSF for treatment of rheumatoid arthritis.
  • Results of pivotal CAPTAIN study to support filing of Trelegy for use in asthma expected.

GSK's Research & Development Pipeline in 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.GSK's approach to oncology is focused on innovation in the areas of immuno-oncology, cell therapy, cancer epigenetics, and most recently in genetic medicine, thanks to our recent acquisition of Tesaro, Inc. and a new global alliance with Merck KGaA. (also known as EMD Serono in the U.S.)

Global strategic alliance with Merck KGaA
  • In February 2019, GSK and Merck KGaA announced a global strategic alliance to jointly develop and commercialise M7824 (bintrafusp alfa), an investigational bifunctional fusion protein immunotherapy currently in clinical development for multiple difficult-to-treat cancers. This includes a Phase II trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced non-small cell lung cancer (NSCLC).It has the potential of offering new ways to fight difficult-to-treat cancers beyond the established PD-1/PD-L1 class as a single agent or for use in combination with other therapies.With this alliance, we can have a leadership position in this new class of immunotherapies, specifically leveraging TGF-β biology. For GSK, this is a further step to strengthen our pharmaceuticals pipeline, along with our recent acquisition of TESARO, Inc., an oncology-focused company based in Waltham, Massachusetts in January 2019.

Acquisition of Tesaro, Inc.
  • GSK's acquisition of Tesaro, Inc. an oncology-focused company based in Waltham, Massachusetts, significantly strengthens our pharmaceuticals business through accelerating of GSK's pipeline and commercial capability in oncology.TESARO has a major marketed oncology product, Zejula (niraparib), an oral poly ADP ribose polymerase (PARP) inhibitor currently approved in the US and Europe as a treatment for adult patients with recurrent ovarian cancer.PARP inhibitors are transforming the treatment of ovarian cancer, notably demonstrating marked clinical benefit in patients with or without germline mutations in a BRCA gene (g BRCA ).GSK also believes that PARP inhibitors offer significant opportunities for use in the treatment of multiple cancer types, therefore Zejula is also being investigated for use as a possible treatment in lung, breast, and prostate cancers, both as a monotherapy and in combination with other medicines, including TESARO's own anti-PD-1 antibody (dostarlimab, formerly known as TSR-042).In addition to Zejula and dostarlimab, TESARO has several other oncology assets in its pipeline, including antibodies directed against TIM-3 and LAG-3 targets.

R&D Collaboration with Merck's Keytruda
  • GSK's experimental drug GSK095 is designed to work in tandem with checkpoint inhibiting medicinesin the hopes of empowering the immune system to launch a more aggressive attack against tumors than it does with checkpoint inhibitors alone. Early results from a preclinical trial of a related GSK drug suggest that the combo holds promise in treating pancreatic cancer-so much so that, in late 2018, we have launched a Phase I of the drug in combination with Merck's blockbuster PD1 checkpoint inhibitor,Keytruda.

Details about our portfolio can be found here: GSK 2018 Annual Report GSK Product Pipeline

For more Information on GSK Oncology, please visit: https://us.gsk.com/en-us/careers/a-career-in-oncology

The Position The Medical Director as a study physician will be responsible for clinical research activities pertaining to advancing the development of GSK's clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key Opinion Leaders.

Job Responsibilities:
  • Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others as necessary to development and execute clinical trials from beginning to end.Contribute to ongoing or planned interventional clinical trials (phase 1-3)
  • In collaboration with clinical teams, drive clinical trial execution to achieve timely completion of clinical studies.
  • Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and safety data review.
  • Conduct safety monitoring in collaboration with CRO pharmacovigilance group of active clinical studies.
  • Analysis, interpretation and presentation of clinical study data.
  • Collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
  • Participate in clinical study report writing and review, using medical expertise to identify ways to best analyze and present data
  • Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.
  • Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK's vision.
  • Represent GSK at medical meetings, advisory boards and outreach meetings as needed/appropriate.
LI-GSK

Why You? Basic Qualifications:
  • MD (or equivalent) with board certification or board qualifications in medical oncology. US State Licensure to practice medicine is desirable.
  • At least 3 years of clinical development experience within the pharmaceutical or biotechnology industry with focus and strong track record of experience with leading oncology clinical trials.
  • Strong working knowledge of the clinical drug development process Track record in the conduct/participation in clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
  • Successful academic research publication history or history of medical practice in a relevant field
  • Solid personal and professional relationships with key opinion leaders (KOLs) in medical oncology. Strong credibility within the US medical community which includes the ability to reach out to key thought leaders in academia.
Preferred Qualifications:
  • Board certification in Medical Oncology

Why GSK?
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
  • Managing individual performance.
  • Creating a performance culture and driving results, prioritisation, execution, delivering performance.
  • Setting strategic direction and leading on-going organisational transformation.
  • Building a resilient organisation.
  • Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
  • Managing P&L and capital allocation.


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