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(Oncology) US Medical Affairs Lead - Cell and Gene Therapy at GlaxoSmithKline

Posted in Science 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Philadelphia, Pennsylvania





Job Description:

GSK has been involved in Cell and Gene Therapy since 2010 and is building a world-leading organization to accelerate the development of these agents for patients with cancer.   Are you committed as we are to rapidly progress these novel cell-based technologies and keen to help us prepare for medical affairs activities to help improve patients lives? Then this opportunity should not be missed.

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.

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


  • 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

New advances in the field of Cell and Gene Therapies (CGT) are transforming science and are unlocking a new approach to medicines development.  GSK have been involved in CGT since 2010 and is building a world-leading organization to accelerate the development of these agents for patients with cancer.   GSK are committed to rapidly progress these novel cell-based technologies, establish new development paradigms, innovative clinical trial designs, production techniques, engage with global regulatory authorities and external experts to effectively scale-up these programs and make these technologies a reality for patients with cancer.    

PURPOSE:

Our medical affairs physicians and scientists are the experts on our medicines/vaccines and an extremely valuable part of our global business. In all countries where our medicines and vaccines are marketed, these professionals help to ensure that healthcare professionals can understand the appropriate use of our products and ensure that the patient remains at the heart of our decision making.  Our Global Medical organization, under the leadership of Sabine Luik, SVP-Global Medical & Regulatory Affairs and Chief Medical Officer, is at the forefront of the industry-leading changes to improve patient treatment options.  We are committed to making GSK’s Medical Affairs team the best in our industry, and a trusted valued partner in the delivery of healthcare to patients. 

The US Medical Affairs (USMA) organization is part of the Worldwide Medical Affairs in R&D. The Worldwide Medical Affairs organization includes Japan and the US in addition to Local Operating Companies (LOCs) in Europe, Emerging Markets & Australia and China. Within USMA, there are three primary Therapy Areas:  Oncology; Respiratory; and Specialty, Classic & Established Medicines. Each team is supported by Medical/Scientific Directors, health outcome scientists, field medical liaisons, medical information scientists, strategic capabilities, medical governance, operations and analytics. The US Medical Affairs organization provides critical insight into the needs of US Medical customers and patients, ensuring the accuracy and relevance of GSK’s medical and scientific information in the US and assessing the evidence needs for US prescribers and payers.

The US Medical Affairs Lead - Cell and Gene Therapy is the single point of medical accountability for a medicine or medicine(s) and leads the development and execution of US Medical Affairs strategies for a medicine(s) including (if applicable) the launch optimization of such medicine(s). The US Medical Affairs Lead - Cell and Gene Therapy reports to the VP and Therapy Area Head- Oncology.


  • Aligns and directs all medical affairs resources into a focused vision and strategy

  • Provides one medical affairs voice, medical expertise, and insight within the US

  • Collaborates with clinical development to provide insights and ensure US needs and issues are addressed

  • Incorporates US Medical Affairs voice at the global franchise or business unit level

RESPONSIBILITIES


  • Responsible for the direction and execution of all medical affairs work for a medicine(s) by leading the US Medical Matrix Team(s) and co-leading the US .

  • Leads the development and execution of the US Medical Affairs Plan and the medical sections for the strategic launch plan for one or more medicines.

  • Incorporates medically appropriate health outcomes research over the lifecycle of the medicine(s) to meet US reimbursement needs.

  • Leads the interpretation, translation and integration of medical voice of customer (patients, providers, payers) into medical affairs strategy and prioritizes patient’s benefit and welfare.

  • Maintains deep product and disease expertise on the medicine(s) and includes market and competitive knowledge in all medical plans.

  • Oversees the design and delivery of Phase IIIB/IV studies (US Pharma funded) and provides input in the selection of investigator sponsored studies in alignment with the global franchises.

  • Collaborates with field based medical team to lead appropriate US scientific engagement between GSK and external communities.

  • Proactively partners with commercial, clinical development and the global franchise to deliver all medical activities to support life cycle management and instills integrity of scientific content of these activities.

  • Closely aligns with safety, regulatory, and manufacturing to ensure best benefit-risk assessment and to quickly integrate relevant changes.

  • Provides development, coaching and other support as needed to direct reports

*LI-GSK

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:


  • Medical Doctor with board Certification (or equivalent credentials)

  • Extensive US Pharma/Biotech industry experience in medical affairs and/or clinical development with a specific focus in oncology

  • Significant disease and therapeutic area knowledge

  • Effective team and matrix and line management leadership, with proven ability to motivate, influence, negotiate, and collaborate

  • Excellent communications and leadership skills with a demonstrated ability in building collaborative relationships – ability to work effectively with others, delegate appropriately and foster a culture of collaboration.

  • Strong business acumen and communication skills (oral and written), including the ability to identify and articulate the value of clinical and heath outcome data to internal stakeholders and external customers.

  • Product lifecycle management experience, including the ability to detect and foresee potential changes in the healthcare, regulatory and competitive environments throughout the product lifespan; to understand the impact of new data on the value / positioning of products in guidelines / formularies; and to proactively identify unmet needs and how to address them.

  • Robust knowledge of the US Oncology healthcare environment including disease-specific research priorities, public health need, competitor landscape, clinical practice trends and treatment guidelines evolution.

Clinical research/drug development experience obtained while working in the pharmaceutical industry or substantial clinical trial experience collaborating with pharmaceutical sponsors in either the academic or clinical practice setting is desirable

Preferred Qualifications:

If you have the following characteristics, it would be a plus:


  • Board Certification (or equivalent credentials) in Hematology or Oncology Preferred

  • Clinical research/drug development experience obtained while working in the pharmaceutical industry or substantial clinical trial experience collaborating with pharmaceutical sponsors in either the academic or clinical practice setting is desirable.

Why GSK?

Our values and expectations are 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.



If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (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.

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