- Lead a team of US medical affairs senior directors with responsibilities for multiple assets in-line and launch readiness disease areas months pre-authorization).
- Ensure novel and aligned medical objectives are thoughtfully incorporated into Global Respiratory Medical Affairs plans and US Integrated Brand Strategy to address unmet patient/provider needs and support strategic imperatives at the enterprise level.
- Create strong collaborative partnerships internally with key stakeholders: Global VP/Heads Medical Affairs, VP US Marketing, Global R&D Clinical Development area leads to foster strong communication, understanding, and advocacy for the US and Medical Matrix Teams for in-line and pre-launch assets and disease areas.
- Accountable for building strong priority external relationships and scientific engagement with key external experts, academic accounts, societies, patient advocacy groups in respective disease areas in support of USMA Portfolio-Level strategic engagement goals.
- Provide leadership for regulatory agency support as needed with FDA, label reviews, safety discussions, etc.
- Work in partnership with central teams, to optimize plans in support of a reimbursable file and life cycle strategy.
- Share medical insights and advocate with cross-functional partners to shift strategy and plans (US, Commercial, Global, Clinical Development, Regulatory) as needed and act based on informed US feedback from external stakeholders, including changes to protocol design, publication planning, evidence generation, integrated strategic plans, etc.
- Accountable for review of US VEO plans for in-line and pre-approval months) in partnership with US VEO business partner and input into novel evidence generation to meet US needs. · Help define strategic areas of interest and provide leadership to ensure US Investigator Sponsored Studies are moving through internal strategic and process pathways. Advise on development of US collaborative trials.
- Establishes exemplary collaboration with VP, US Marketing to ensure strategic alignment with Internal Brand Commercialization Teams within US Business Unit.
- Provide medical leadership and decision making for Promotional Review Committee escalations. · Provide US medical input and expertise into potential BD&L activities related to respective disease areas. · Responsible for leading and developing teams and people including recruitment and talent reviews. · Accountable for financial planning and operational budget goals for in-line asset plans
- PharmD, PhD, or allied health professional with advanced scientific degree
- Must have US Medical Affairs leadership experience and US (or Global) asset launch experience
- 5+ years of Medical Affairs Experience
- Clinical and industry expert in the specified therapeutic area
- Demonstrated success in inspiring/leading/managing teams and cross-functional work
- Drug development (early through late stage) experience with knowledge of GCP regulatory/ market access and reimbursement requirements.
- US Medical Affairs and life cycle management preferred, including launch support requirements.
- Demonstrated ability to build strong internal and external networks with superior external stakeholder management skills across clinical, scientific, population health, policy, and regulatory
- Significant disease and therapeutic area knowledge.
- Robust understanding of US promotional codes/ regulations; previous involvement in review and approval processes
- Highly developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment.
- Excellent presentation and media skills for both internal and external audiences.
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GlaxoSmithKline, plc Philadelphia, United StatesThe US Medical Affairs (USMA) Sr. Medical Lead, Respiratory Portfolio will drive senior scientific leadership with strong and compliant medical strategy and exemplary medical performance as part of an integrated brand ambition. Deliver insight genera Medical, Respiratory, Portfol ...
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USMA Senior Medical Lead, Respiratory Portfolio - Philadelphia, United States - 1925 GlaxoSmithKline LLC
Description
Job Purpose
The US Medical Affairs (USMA) Sr. Medical Lead, Respiratory Portfolio will drive senior scientific leadership with strong and compliant medical strategy and exemplary medical performance as part of an integrated brand ambition. Deliver insight generation and builds plans for evidence needed in partnership with Medical Commercialization, Market Access, and Value Evidence & Outcomes – US and Globally.
The Sr. Medical Leader is accountable for the USMA strategic plans that support multiple in-line and pre-launch assets in a portfolio of disease areas, including new indications. The Sr. Medical Leader partners closely with Global Respiratory Medical Affairs VPs/Heads of the Respiratory Disease areas, Global R&D Respiratory area leads, Regulatory area leads, and US VP & Head, Marketing.
The Sr. Medical Leader is a core member of USMA TA Leadership team, US BU Leadership Team and Commercialization Strategy teams, and Global Medical Affairs strategic boards. The Sr. Medical Leader is also accountable for ensuring evidence generation (Phase IIIb, IV, VEO) and publications plans meet US needs and address unmet patient needs.
This role reports to the VP & Therapeutic Area Head, US Medical Affairs
Key Responsibilities
Basic Qualifications:
Preferred Qualifications:
Please visit 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.
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.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
USMA Senior Medical Lead, Respiratory Portfolio professionals in Philadelphia
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Carl Denys
Senior Executive - Medical Devices - Go to Market