Associate Director / Director, Managed Access (Oncology)

The Director provides strategic and operational leadership for TUMM activities, including Expanded Access, Post Trial Access and Compassionate Use Programs. The role is responsible for providing vision and leadership to ensure that Managed Access programs are embedded in GSK culture and ethics, and that GSK delivers access to our medicines for patients with unmet need who have no reasonable treatment option. This Director is responsible for planning and operationalizing of asset-based programs working closely with Global Medical Leads. The director is the strategic and/or operational contact for global stakeholders and is responsible for collaboration with CMO leadership to assure programs are built, led, and managed according to GSK policies, SOPs and ethics. The Director should have a solid understanding of oncology based clinical research and the use of unapproved products for compassionate use/expanded access. The candidate must have a strong ability for and desire to expand upon their knowledge of GSK oncology pipeline products across multiple disease indications. The Director will be responsible for establishing strong partnerships with internal and external teams including physicians, medical directors, MSLs, internal cross functional team members, local operating countries, and other partners. Please note that the scope of your responsibilities will vary depending on the position for which you are hired. Responsibilities

• Lead the continued development and growth of TUMM activities at GSK in partnership with TA head, GMLs, and Office of the CEO, and cross functional partners.
• Provide strategic and operational leadership for GSK oncology TUMM programs including Expanded Access, Compassionate Use, Post Trial Access, and other program activities.
• Plans and strategies for program footprint, drug supply, regulatory coordination, physician oversight, vendor set up and management, safety reporting, and other related activities accordance with GSK Policies and SOPs.
• Select and oversee the management of vendors associated with access programs.
• Builds expertise in country level regulatory environment, importation requirements that are shared across all GSK TA s and programs.
• Ensures program metrics and management monitoring are performed.
• Establish strong relationships with internal and external stakeholders, including Global Medical Affairs colleagues, Supply, Regulatory and Safety teams, LOCs, HCPs.
• Stays current with the external environment that may impact GSK Managed Access activities including industry standards, country level regulations, requests from regulators and payers other updates.
  
  Proven leadership skills with experience working motivating team members.
• Flexible, resourceful, creative, enthusiastic, and results oriented.
• Proven ability to work with a high level of integrity, accuracy, and attention to detail.
• Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting to complete assignments on time and on budget.
• Strong technical/analytical skills to identify and solve problems.
• Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
• Comfortable with ambiguity and can make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
• Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
• Ability to thrive in a fast-paced environment., Scientific degree with significant progressive experience either in Medical Affairs / Clinical Science or Clinical Operations field. Advanced scientific degree is preferred.
• Proven experience with Managed Access program.
• Oncology medical or scientific experience highly preferred but other Therapy Areas are also welcome.
• Demonstrated experience with contracting and managing Vendors.
• Demonstrated knowledge of protocol design in oncology studies.
• Thorough knowledge and understanding of FDA, ICH, GCP, and OIG guidelines.
• Strong planning and project management skills.
  
  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. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are., Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov