VP - Clinical Development - Immuno-Oncology
- Collegeville, PA
Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Jan 15 2021
Are you a pharmaceutical executive with expertise in oncology medicine development and successful drug registration and you seek to join a company committed to focus on Oncology R & D? If so, this VP position may be ideal for you to explore.
GSK Oncology is in an exciting and expanding transformation in response to a significant increase in GSK's early and late stage medicine development volume in Oncology. This transformation has resulted in a rapidly expanding portfolio of clinical development assets requiring both strong scientific and clinical development expertise and leadership skills for influencing internal and external stakeholders. In that regard, GSK seek a Vice President - Clinical Development to support the Immuno-Oncology platform. The position of VP reports to the SVP- Oncology Clinical Development
GSK Oncology R&D is focused on building industry-leading portfolios in four cutting-edge areas of science:
•Immuno-Oncology : using the human immune system to treat cancer
• Cell/Gene Therapy: engineering human T-cells to target cancer
•Cancer Epigenetics: modulating the gene-regulatory system of the epigenome to exert anti-cancer effects
•Synthetic Lethality: targeting two mechanisms at the same time which together, but not alone, have substantial effects against cancer
For more Information on GSK Oncology, please visit:
GSK's Oncology Transformation: https://bit.ly/2zTytwmon https://www.lifescienceleader.com/doc/building-gsk-oncology-r-d-0001 ASCO 2020: https://us.gsk.com/en-us/gsk-at-asco-2020/
Axel Interview 2.0 : https://urldefense.com/v3/https://xconomy.com/national/2020/06/12/glaxosmithkline-keeps-oncology-2-0-growth-plans-on-track/2/;!!AoaiBx6H!jzE3gZin5i5U6-4GipkOCaogED6cJDtNaH30f1ZPo4TTWmnNsGGVSOUYqSFDLfJS$
IO PIPELINE AT A GLANCE
Blenrep (GSK2857916, BCMA immunoconjugate)
The first patient was dosed in the pivotal second line multiple myeloma study, DREAMM-8, of Blenrep in combination with pomalidomide and dexamethasone.
The European Commission granted approval and marketing authorization of Blenrep® for the treatment of patients with relapsed and refractory multiple myeloma
The US FDA granted accelerated approval of Blenrep® for the treatment of patients with relapsed and refractory multiple myeloma
Dostarlimab (TSR-042, PD-1)
New data from the GARNET study of dostarlimab in patients with advanced or recurrent DNA mismatch repair deficient (dMMR) or proficient (MMRp) endometrial cancer were presented at ESMO 2020 as a late-breaking presentation.
Bintrafusp alfa (TGF beta trap/ anti-PDL1)
Three-year follow-up data for first-in-class bifunctional immunotherapy bintrafusp alfa targeting TGF-β/PD-L1, in second-line NSCLC, and twenty-eight month follow-up data for patients with pre-treated biliary tract cancer were shared at ESMO 2020.
GSK3359609 (ICOS receptor agonist)
The first patient was dosed in the INDUCE-4 Phase II/III gated study of GSK'609 in combination with pembrolizumab and chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma.
Following GSK's 2019 acquisition of Tesaro, the Oncology organization has undergone a substantial transformation with a significant increase in early and late-stage medicine development volume in Oncology. A key part of this transformation also includes GSK's focus in Oncology as one of the core strategic focus areas of medicine.
This transformation has resulted in a rapidly expanding portfolio, requiring both strong scientific and clinical development expertise along with exceptional leadership skills for influencing internal and external stakeholders. On this basis GSK has established the new role of VP Clinical Development, IO to focus on the continued advancement of the IO pipeline.
GSK is now seeking to appoint a new Vice President Clinical Development, IO to further advance the objective to be a leading player in Oncology by offering transformational benefit to patients, focusing on cutting edge innovation within the Oncology arena.
The VP Clinical Development, IO will play a central role within the Oncology TA as s/he will be responsible for architecting and implementing the clinical development strategy for the IO portfolio and ensuring the allocation of the necessary resources within the GSK R&D budget to advance the development and launch of transformational new medicines.
Reporting to the SVP Oncology Clinical Development, the VP Clinical Development, IO will be accountable for all aspects related to the clinical development of the clinical stage assets in the Immuno-Oncology portfolio.
This individual will be responsible for managing physicians and clinical scientists assigned to the clinical development team(s). As a key responsibility, the VP Clinical Development, IO will supervise the design and implementation of the clinical development strategy and plan for the Immuno-Oncology portfolio, including the strategic clinical positioning of individual assets, the effective allocation of development resources, and the timely and successful execution of clinical trials.
This role of VP Clinical Development, IO requires an experienced, cross-matrix senior leader capable of leading a team of 45+ FTEs focused on implementing and executing an integrated clinical strategy in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Immuno-Oncology agents.
The successful candidate will be accountable for:
- End-to-end clinical development of the Immuno-Oncology portfolio from First Time In Human (FTIH) clinical trials through Proof-of-Concept (POC) studies, and pivotal trials to regulatory approval and initial market launch.
- Providing medical guidance for pre-clinical research activities from drug candidate Selection through to POC.
- Building and maintenance of effective business partnerships within GSK Oncology R&D and with external partners and collaborators.
- Leading intra- and inter-departmental teams, matrix-management of cross-functional teams.
Problem Solving & Innovation
- The role of VP requires exceptional problem solving skills and innovative thinking in order to anticipate emerging therapeutic standards in Oncology and to successfully position the GSK portfolio of Cancer Epigenetic compounds in an increasingly competitive pharmaceutical business environment
- The role of VP requires strong interpersonal and communication skills in order to successfully promote the strategy guiding the clinical development of the Immuno-Oncology portfolio within the GSK organization and to generate interest in the international, scientific and clinical Oncology community for emerging drug development programs and transformational, new therapies.
- The role of VP requires an in depth understanding of multi-cultural responsibilities in order to organize, motivate, and lead multi-functional teams of scientific and clinical experts located in different research centers within the global GSK R&D organization
- The VP - Clinical Development - Immuno-Oncology will play a central role within the Oncology TA as he will be responsible to enforce the clinical development strategy for the Immuno-Oncology portfolio and ensure the allocation of the necessary resources within the GSK R&D budget to development and launch transformational new medicines
- Medical Degree with qualifications in a related medical specialty
- At least 5+ years clinical development experience in the pharmaceutical industry, including late stage development and registrational experience
- Experience with clinical and translational investigation of cell-based therapy, cancer immunotherapies and/or Immuno-Oncology modifiers is a plus.
- Relevant experience in early phase drug development and translational medicine is an advantage
- Demonstrated track record of successfully developing and executing Clinical Development Plan
Key professional requirements for this role will include:
- Scientific expertise in experimental Oncology with an emphasis on Immuno-Oncology or related fields of research.
- Ability to develop a competitive, long-term strategic vision for the Immuno-Oncology portfolio.
- Track record in the planning and execution of early and late-stage clinical Oncology projects.
- Experience integrating translational research activities into first-time-in-human (FTIH) trials to establish clinical proof-of-concept.
- Experience working with regulatory agencies and ability to provide clinical leadership for the filing of INDs and NDAs.
- Experience managing the interface between R&D and Commercial Oncology business units.
- Experience working with external scientific experts and clinical key-opinion-leaders to position clinical development programs in a highly competitive business environment.
- Expertise in planning and executing risk-adjusted clinical development programs with high agility and accuracy.
- Experience managing and motivating multi-functional project teams.
- Managerial expertise in establishing clear accountability, alignment and connectivity within clinical development teams.
- Strong motivation to advance Immuno-Oncology R&D to establish an industry leadership position.
- Desire to work collaboratively within the Oncology organization to identify transformational clinical development opportunities.
- Preferred Qualifications:
- Medical degree with sub specialty qualifications in Oncology
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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