Vaccines Development Lead - Shingrix at GlaxoSmithKline
Posted in Health Care 30+ days ago.
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Location: Annapolis, Maryland
Position Title: Vaccines Development Lead - Shingrix
Working Location: Maryland
Employment Status: Full time
Required Experience: 7 years
Required Education: Masters
Travel Required: 10%
The Vaccine Development Leader (VDL) manages one or more development projects and leads one or more cross functional vaccine development teams (VDTs or lifecycle (LC) development streams) to drive the development of the vaccine candidate from “Proof-of-principle” to launch. The VDL may also support Vaccine Commercialization Team(s) (VCT) on life cycle management (LCM) projects for marketed vaccines.
The VDL drives the strategy, in alignment with the portfolio strategy, overall delivery, and effective resource management (including budget accountability) for the project assigned to him/her.
• Take direct responsibility for one or more development projects (new vaccine and/or LCM)
• Generate and regularly update the Integrated Development Plans for the assigned projects.. Provide project strategy support to the functions/matrix team members accountable for delivering the appropriate project evidences (e.g., TPP, asset profile, value pack, CDP, GRP, ERP, COS, risk register, PTS and costs,…).
• Lead one or more Vaccine Development Team (VDT) or LC development streams embracing all required components of the business: e.g. Regulatory, Preclinical and Clinical Development, Medical Affairs, Commercial, Technical Development, Manufacturing, Health Economics, Epidemiology, Global Patents, Business Development, etc…
• Lead, empower and set clear expectations to team members and sub-teams to deliver project strategy and project evidence timely, within budget and with the highest quality. Make the final decision in the absence of team consensus.
• Drive the preparation for presentations to GSK governing bodies ensuring the right information to drive the optimal decision.
• Endorse resources, costs, risks and timelines for product development, and resolution of issues requiring changes to the plan and assuring smooth transitions between key decision points and making the final decision in the absence of consensus.
• Be the focal point throughout the organization on the assigned projects and represent the project voice at the strategic decision making table.
• Participate in selection of the matrix team members, personal objective setting and evaluation of performance of team member.
• Provide input performance assessment and contribute to professional development and recognition of project team members in collaboration with member’s functional N+1.
• Ensure that patient and customer’s unmet needs and insights (regulatory authorities, LoCs, payors, policy makers) are sought and incorporated appropriately into the functional plans (e.g. Medical Affairs, Epidemiology, Health Outcomes, etc.) including appropriate engagement of external experts/scientific community
• Lead internal & external communication strategy outside of the data dissemination plan (e.g. info-projects, R&D news, Publication of data) for his/her project(s)
• Promote project-related innovation and generation of intellectual property
• Responsible for approval of scientific engagement activity for pre-approval indications.
• MD, PhD or Master Degree (University Degree) in life sciences (animal sciences, (molecular) biology, vaccinology, immunology, infectious disease), pharmacy.
• At least 7 year experience in biopharmaceutical, biotechnology industry, or governmental vaccine development organization.
• At least 3 year experience in matrix management
Expertise & skills
• Knowledge, experience and understanding of the development process from asset inception through lifecycle management
• Scientific depth and the integrated knowledge of all aspects of the vaccines business
• Track record of successfully demonstrating the GSK Leadership Expectations
• Experience in managing a cross-functional team with diverse skill sets and implement strategies within a complex matrix organization.
We are an Equal Opportunity Employer and do not discriminate against
any employee or applicant for employment because of race, color, sex,
age, national origin, religion, sexual orientation, gender identity,
status as a veteran, and basis of disability or any other federal,
state or local protected class.