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(ONCOLOGY) USMA Medical Director - Cell & Gene Therapy (NY-ESO-1) at GlaxoSmithKline

Posted in Science 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Philadelphia, Pennsylvania





Job Description:

Are you interested in a career step where you can make more impact and get in on the ground floor of GSK's oncology build in US Medical Affairs? If so, this Medical Affairs Medical Director role 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.

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.    

MEDICAL AFFAIRS AT GSK

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

PURPOSE:

The Medical Director is accountable for the work of US Medical Affairs for a specific medicine(s) in partnership with the Global Franchise, R&D, US medical matrix team(s) and US medical commercial strategy team(s).  The incumbent should be able to contribute to the development and execution of the US Medical Affairs Plan and the medical sections for the strategic plan for one or more medicines integrating US environment and medical voice of customer (patients, providers, payers) into medical affairs strategy.  In addition, the candidate must ensure US needs for medical and health outcomes evidence generation are represented and incorporated into the global medical work and recommend scientifically appropriate measures within health outcomes research over the life cycle of the medicine(s) to meet US reimbursement needs.

KEY RESPONSIBILITIES:


  • Ensure US external experts are appropriately engaged over the life cycle of the medicine in close collaboration with the field medical organization to gain insights into our medicine(s) and diseases through advisory boards, consultations, scientific meetings, publications and research related activities.

  • Provide input to the global Integrated Evidence Plan for the medicine(s) and should be able to lead the design and delivery of US-focused late phase studies in collaboration with the Global Franchises, act as medical monitor when appropriate and manage US funded investigator sponsored studies.

  • Partner with stakeholders to ensure delivery of all assigned medical activities to support life cycle management, ensuring integrity of scientific content and sound medical governance.

  • Work closely with R&D, Global Franchise, safety, regulatory, and manufacturing to ensure appropriate decisions based on a benefit-risk assessment.

  • Serve as the US Medical Affairs point of contact for safety issues and contribute to the copy approval process.

  • Approximately 20% travel, mostly domestic, may be required.

*LI-GSK

Why you?

Basic Qualifications:

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


  • Physician (M.D. or equivalent) with demonstrated interest and experience in Oncology. Active or eligibility for a US Medical license (or equivalent previously outside of the US) is required. 

  • In-depth knowledge of Oncology especially related to disease mechanisms, patient care, treatment options, clinical decision making, and key issues and advances in the field.

  • Familiarity with the key medical/scientific experts in the Oncology field with the capability of effectively interacting and/or collaborating with the experts.

  • Effective team leadership, with proven ability to motivate, influence, negotiate, and collaborate; strong project management skills; solid planning and organizational skills; strong scientific/analytical problem-solving skills.

  • 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 life cycle 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 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 preferred.

  • Knowledge and experience in late phase trials and solid knowledge of drug development and FDA guidance to industry.

  • Teaching skills.  The candidate is expected to become the educator-in-chief on his/her medicine within the US Medical Affairs group.

Preferred Qualifications:

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

  • Board certification in Oncology is preferred 

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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