Executive Medical Director/COPD Hub Leader- US Medical Affairs
- Physician (M.D. or equivalent) with board certification. Active or eligibility for a US Medical licensure (or equivalent previously outside of the US) is required. Board certified Pulmonologist or Allergist.
- Demonstrated ability of interacting with the key medical/scientific experts the capability of effectively interacting and/or collaborating with the experts to develop and execute medical strategies
- Medical Affairs is required and Clinical Development experience is strongly preferred.
- Effective team and matrix and line management 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 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 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.
- 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 be the educator-in-chief on his/her disease area within the USMA group.
The ideal candidate will demonstrate the following competencies:
- Excellent communications and leadership skills.
- Learning agility – ability to rapidly acquire and integrate new information and knowledge and apply them in a constantly changing environment.
- Enable and drive change –ability to influence/lead directly to deliver results, proactively look for new opportunities and constantly anticipate the need for change.
- Building collaborative relationships – ability to work effectively with others, delegate appropriately and foster a culture of collaboration.
- Customer driven – ability to understand patient needs and institutional concerns, integrate into strategies and build a team that is customer-focused.
- Continuous improvement – ability to drive a performance-based culture.
- Flexible thinking – ability to analyze the external environment and translate to strategy and gain support of others to implement a vision. Must demonstrate good judgment.
- Developing people – ability to develop influencing/leadership skills in others, act as teacher, coach and mentor toward others.
GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical companies. Our powerful combination of skills and resources provide the platform for delivering strong growth and the platform for responding quickly to the rapidly changing global healthcare environment. We are a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. We have a significant global presence with commercial operations in more than 150 markets, a network of 86 manufacturing sites in 36 countries and large R&D centers in the UK, USA, Spain, Belgium and China.
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 also ensure that the patient remains at the heart of our decision making. Our Global Medical organization, under the leadership of R&D, Chief Medical Officer Murray Stewart, 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 Executive Medical Director, COPD Hub Leader is the accountable leader of a portfolio of respiratory products used in the treatment of COPD, delivering therapy area strategic and cross functional resourcing to ensure successful launch and/or lifecycle management for the US Respiratory Franchise. The incumbent is responsible for ensuring strategic alignment with Clinical Development, the Global Franchise and US Pharma. The incumbent should be able to lead a staff of medical and scientific directors in developing and executing multiple US Medical Affairs Strategic and External Engagement Plans. 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 lifecycle of the medicine(s) to meet US reimbursement needs.
The leader will ensure Global and US external experts are appropriately engaged over the life cycle of the medicine in close collaboration with the Global Franchise Medical Leaders and US field medical organization to gain insights into our medicine(s) and diseases through advisory boards, consultations, scientific meetings, publications and research related activities. This person will provide input to the global Integrated Evidence Plan for the medicine(s) and lead the design and delivery of US-focused late phase studies in collaboration with the Global Franchise, critically review Investigator-sponsored US studies, and manage US funded studies. Also, (s)he will 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. The incumbent will work closely with R&D, Global Franchise, safety, regulatory, and manufacturing to ensure appropriate decisions based on a benefit-risk assessment. In addition, the Medical Director will serve as the COPD US Medical Affairs point of contact for safety issues and lead/contribute to the copy approval process. Approximately 20% travel time, mostly domestic, will be required.
The COPD Hub Leader is expected to develop and lead a "community of expertise" in COPD by ensuring appropriate training, knowledge sharing and dissemination, and external engagement for all COPD hub staff. They should maintain an effective personal network both internally and externally. They will directly line manage a 4-5 member staff of scientists and physicians, and coordinate utilization of deployed Medical Affairs resource from other Medical Affairs functions across the COPD portfolio.
In addition, the COPD Hub Leader is a core member of the US Respiratory Therapy Area Leadership team, working in collaboration with functional and other hub leaders (Asthma and Biologics) to build a culture of excellence in Medical Affairs, ensure strategic alignment across the broader portfolio and work with other Respiratory TA leaders to role model effective matrix working and enterprise thinking/problem solving.
Please use the cover letter to highlight how you meet the qualifications and competencies for the role. Your CV along with your cover letter will be used to assess your application.
You may apply for this position online by selecting the Apply now button.
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