Manager, Oncology Managed Access Program
4 weeks ago
Site Name: USA - Massachusetts - Waltham, Durham Blackwell Street, GSK House, Stevenage, Upper Providence, Ware RD, Zug House
Posted Date: May
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.
As Manager, Oncology Managed Access Program you will provide strategic and operational management for expanded access and/or compassionate use programs. This position is responsible for planning and operationalizing of asset based programs in conjunction with Global Medical Affairs Leads and sets up processes from initial patient request through program transition.
Key Responsibilities- Work with internal stakeholders, provide operational leadership for GSK oncology expanded access/compassionate programs including plans and strategies for footprint, drug supply, regulatory coordination, physician oversight, vendor set up and management, safety reporting, and other related activities accordance with GSK Policies and SOPs
- Oversee the management of vendors associated with access programs
- Set up operations to ensure rapid response to requests from physicians regarding patient access to EAP/CU programs
- Provide regular status updates on program utilization to internal stakeholders
- Provide operational input and assistance when required
- Establish strong relationships with all stakeholders, including Global Medical Affairs colleagues, LOCs, physicians, program managers, regulatory and safety teams
- BSc degree in a life science related field
- Four or more years of demonstrable, varied, and progressive experience in a professional scientific or clinical role, either in Medical Affairs/Clinical Operations or at a relevant institution or vendor
- Two or more years of experience managing an individual compassionate use program or Expanded Access Program, or proven experience managing clinical research studies in a professional setting
- Oncology medical or scientific experience very much desired
- Experience managing Vendors
- Demonstrated knowledge of protocol design in oncology studies.
- Strong planning and project management skills
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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GSK is an Equal Opportunity Employer and in the US, we adhere to Affirmative Action principles. This ensures that 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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