Us Medical Affairs Lead, Specialty New Medicines

3 weeks ago

Collegeville, United States GSK Full time

**Site Name**: USA - Pennsylvania - Upper Providence

**Posted Date**: Apr 25 2024

**Job Purpose**:
The US Medical Affairs Lead for Specialty New Medicines is focused on providing US medical leadership, input and support for emerging assets in development, ensuring US Market needs/insights are considered and integrated into product development, evidence generation, and launch plans. This role will also work with the US Specialty Therapeutic Head to ensure the US Medical team has the appropriate expertise and resources in place to support new medicines coming to market. They will partner closely with Commercial New Product teams, Global Medical Affairs, and R&D teams.

**Key Responsibilities**:

- Maintains understanding of US market dynamics and treatment landscape associated with priority pipeline assets in the Specialty Medicine Research units.
- Serves as the US representative on pipeline Global Medical Affairs teams and co-creates medicine strategy and plans; Represents US Medical Affairs interests across matrix teams to ensure medical plans represent the needs of the US business
- Gathers and communicates medical insights from internal and external stakeholders (Investigators/HCP’s, Patients, Payors and Regulators) to shape product development decisions, Global Medical Affairs Plans, and integrated evidence strategy and plan.
- Develops the US strategy and operational plan for Specialty assets in the pipeline laying the initial foundation for future US Medical Affairs launches; Performs advanced scenario-planning and preliminary preparation for US launches
- Inputs into the design of Clinical Trials, development plans, and Integrated Evidence planning; coordinating with relevant Global Medical Team roles and R&D technical experts e.g. Global Value Evidence and Outcomes and Epidemiology as required.
- Understands and communicates clinical and market access data requirements for US market; shapes clinical and health outcomes evidence plans to support anticipated US Market needs
- Partners with Global Medical Affairs on Advisory Board design and discussion, ensuring compliance with SE governance and documentation requirements
- Leads US Medical/Clinical Operations partnership process, determining scope of US Medical Affairs support for ongoing US Clinical Trials.
- In partnership with US Medical Affairs Lead and US Head, ensures early input into priority US research site strategy (COEs, Cooperative groups, Research Networks); builds external relationships in partnership with Field Medical and collaborates with internal R&D stakeholders to foster internal relationships with external experts & leaders.
- Facilitates preparation for GSK Product Investment Board reviews and other governance meetings, ensuring compliance with timelines and required inputs
- Collaborates with the Group Head of the Field Medical Team and other relevant internal stakeholders on pipeline progress in order to inform field strategy and resourcing.
- Serves as Medical point for US input into Business Development and Acquisition opportunities
- In partnership with US Medical Communications and Scientific Training team, shapes, reviews, and approves Globally created Scientific Communication and Medical Information materials that will be used with US HCPs, ensuring alignment with US medical strategy and business needs
- Effectively manages transition of assets to Medical Matrix/Launch teams
- Accountable for budget management to plan

**Why You?**:
**Minimum Qualifications**:

- Education: PharmD, PhD, nursing, allied health professional (eg, epidemiology) or other Advanced scientific degree.
- Experience: 5+ years of experience in Pharmaceutical Industry with Medical Affairs experience

**Preferred Qualifications**:

- Medical Doctor
- Board Certification (or equivalent credentials)
- Demonstrated success leading and managing 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.
- Significant diverse disease and therapeutic area knowledge.
- Robust understanding of 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.
- Demonstrated ability to build strong internal and external networks.
- Ability to effectively collaborate and influence in a highly matrixed environment.
- Adaptable to a dynamic environment and shifts in business priorities
- Strong business acumen including:

- understanding of medicine development stages, clinical development, and lifecycle planning
- market research
- understanding of asset forecasting and resource planning
- Experience leading and coaching medical professionals
- E

  • VP, Global Vaccine Strategy Lead, Shingles

    2 weeks ago

    Collegeville, United States GlaxoSmithKline Full time

    Site Name: Belgium-Wavre, UK - London - Brentford, USA - Pennsylvania - Upper Providence Posted Date: May 1 2024 Purpose The VP, Global Medical Strategy Lead is a key senior business leadership role, reporting to the VP and Head of Vaccines Global Medical Affairs who is a key member of GSK's Global Medical Leadership Team. The leader will have full...

  • Project Manager, Us Medical

    4 weeks ago

    Collegeville, United States GSK Full time

    **Site Name**: USA - Pennsylvania - Philadelphia, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence **Posted Date**: Apr 19 2024 As the **Project Manager, US Medical **for the US Medical Anti-Infective & Respiratory Therapeutic Area (TA) you will be responsible for providing process, discipline, and structure to support effective...

  • Director, Regulatory Affairs CMC Small Molecule, Mature Products

    1 week ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: USA - North Carolina - Research Triangle Park, Bangalore, India - Maharashtra - Mumbai, Poznan Grunwaldzka, UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date: May 9 2024 Are you interested in a highly visible, global role that allows you to lead a team of regulatory experts while being part of...

  • Associate Director

    3 weeks ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: GSK House, USA - Pennsylvania - Upper ProvidencePosted Date: Apr We're excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we're building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it'll be one of the...

  • Clinical Study Team Lead

    4 days ago

    Collegeville, United States Pfizer Full time

    JOB SUMMARY. - Clinical Development expert focused on the execution of clinical studies and brings that expertise to the design & conduct of clinical studies in alignment with the program and portfolio strategies for the specific category(ies)/Therapeutic Areas. - Single point of accountability for input into study design to ensure feasibility of execution,...

  • Publication Director- Oncology

    1 month ago

    Collegeville, United States GSK Full time

    **Site Name**: USA - Pennsylvania - Upper Providence, Switzerland - Zug, UK - London - Brentford **Posted Date**: Apr 17 2024 The Director, Oncology Publications will lead the establishment of a Strategic Publication Plan in alignment with Global Medical Plans, medical/scientific communication strategy and objectives. In addition, the Global Oncology...

  • Associate Director of Disability and Access and Section 504 Coordinator

    3 weeks ago

    Collegeville, United States InsideHigherEd Full time

    DepartmentAcademic AffairsOverview The Associate Director of Disability and Access and Section 504 Coordinator works to ensure equitable access for students with disclosed disability impacts. The Associate Director collaborates with stakeholders including students, faculty, and staff to create equitable environments that support the success of students who...

  • Senior Cloud Engineer

    2 weeks ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: London The Stanley Building, Cambridge MA, Upper Providence, USA - Pennsylvania - Upper ProvidencePosted Date: Apr The Onyx Research Data Platform organization represents a major investment by GSK R&D and Digital & Tech, designed to deliver a step-change in our ability to leverage data, knowledge, and prediction to find new medicines. We are a...

  • IT Support Technician

    1 month ago

    Collegeville, United States US Tech Solutions, Inc. Full time

    Job Title: IT Support Technician Location: Collegeville, PA 19426 (Onsite Work). Duration: 6+ Months Contract Job Description: Looking for candidates as IT Support Technician who can resolve customer issues in the areas of hardware installation, repair, upgrade, and maintenance, instructs customers in the operation and maintenance of...

  • Campus Safety Officer

    2 weeks ago

    Collegeville, United States Ursinus College Full time

    Department Student Affairs Overview Ursinus College is seeking a full-time Campus Safety Officer (CSO) to work an assigned schedule which will include nights, weekends, and holidays. In addition, the successful candidate will be required to work special events, attend mandatory in-service training, including monthly staff meetings, as well as be available...

  • Data Engineer

    2 weeks ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: UK - Hertfordshire - Ware RD, UK - Hertfordshire - Stevenage, Upper Merion, USA - Maryland - Rockville, USA - Massachusetts - Cambridge, USA - North Carolina - Zebulon, USA - Pennsylvania - Upper ProvidencePosted Date: May 7 2024GSK Pharma R&D is seeking innovative leaders to help improve the global clinical supply chain through data science and...

  • External Label Specialist

    9 hours ago

    Collegeville, United States GlaxoSmithKline Full time

    Site Name: Belgium-Rixensart, UK - Essex - Harlow, UK - Hertfordshire - Ware, USA - Pennsylvania - Upper ProvidencePosted Date: May 16 2024About the role External Label Specialist within Global Pack Management is responsible for the creation and approval of label content for third parties for the following modalities:Vaccines Pharmaceuticals (supplies packed...

  • External Label Specialist

    16 hours ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: Belgium-Rixensart, UK - Essex - Harlow, UK - Hertfordshire - Ware, USA - Pennsylvania - Upper ProvidencePosted Date: May About the role External Label Specialist within Global Pack Management is responsible for the creation and approval of label content for third parties for the following modalities:Vaccines Pharmaceuticals (supplies packed...

  • SENIOR DIRECTOR AND RWA LEAD, RESPIRATORY AND IMMUNOLOGY RU

    2 weeks ago

    Collegeville, PA 19426, USA, United States GlaxoSmithKline Full time

    Site Name: UK - London - Brentford, USA - Pennsylvania - Upper ProvidencePosted Date: May 1 2024We're excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we're building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us,...

  • Senior Director and RWA Lead, Respiratory and Immunology RU

    4 days ago

    Collegeville, PA, United States GlaxoSmithKline Full time

    Site Name: UK - London - Brentford, USA - Pennsylvania - Upper Providence Posted Date: May 14 2024 We're excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we're building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us,...

  • Senior Financial Analyst

    3 weeks ago

    Collegeville, United States PowerSecure International Full time

    PowerSecure has a new opportunity in Finance! As a member of the Corporate FP&A team, this role will be responsible for supporting the monthly reporting, quarterly forecasting and annual budgeting processes, including model building/support, consolidated reporting as well as supporting the Corporate functional teams with managing costs to budget. Minimum...

  • Medical Matron

    1 day ago

    Collegeville, MN, United States MRG Exams Full time

    We are looking for the right Nurse Practitioner to perform medical assessments on United States Veterans as part of the VA's disability benefits process. In performing Disability Assessments, you will review medical records electronically through a web portal and perform a focused, in-person physical exam on each Veteran. You will electronically document...

  • Director, Tech Product

    2 weeks ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: London The Stanley Building, UK - Hertfordshire - Stevenage, USA - Massachusetts - Cambridge, USA - Pennsylvania - Upper ProvidencePosted Date: May 8 2024Director, Tech Product & Data Governance Product PortfolioThe Onyx Research Data Platform organization represents a major investment by GSK R&D and Digital & Tech, designed to deliver a...

  • Medical Sonographer-PRN

    1 month ago

    Collegeville, PA, United States Jefferson Outpatient Imaging Full time

    Are you passionate about patient care? Come and join our team as an Ultrasound Technologist PRN working shifts as needed at our outpatient imaging center located in Collegeville and Malvern PA. Apply for immediate consideration! We offer a total compensation package including competitive base pay and for benefits eligible a comprehensive benefits program...

  • Senior IT Procurement Manager

    1 day ago

    Collegeville, United States eTeam Full time

    POSITION TITLE: Senior IT Procurement Manager - Core Technology DURATION: 6 Months from start date (Potential for extension and/or conversion) SHIFT: (M - F / 9am - 5pm) Pay Range: $92.14/hr on W2 to $92.14/hr on W2 HYBRID (Upper Providence and Philadelphia (FMC) Are you looking for a highly visible procurement leadership role that allows you to shape...