Demonstrated track record of being a team player and a leader, with hands-on experience in leading teams of science towards delivery of novel therapeutics from target identification to pre-clinical development.
Develop risk management plans with the initial focus on physical contamination (PCCE) that will anticipate reliability related and non-reliability related risks that could adversely impact plant operations.
Leverage your expertise as you work with our Platform Engineering team and focus on the design, contexts and multiple touch points; lead human-centered design activities that frame business and customer problems.
The successful candidate will participate in multidisciplinary drug discovery teams by contributing novel genomics and chemistry analyses (chemogenomics) on human host-microbe interactions; provide expert knowledge to scientific teams.
In this role, you will have an opportunity to drive the UI and UX of the new DevMarket platform focused on developers and technology partners; work with interdisciplinary teams to find metrics to measure your designs against business needs.
Facilitate team expertise in emerging science of our compounds and that of our competition to educate the EEs and other HCPs as appropriate; provide strategic medical advice in the US on pre-launch, launch and lifecycle management activities.
Applies and integrates deep understanding of the external medical and scientific environment to the medical affairs strategy; partners with all stakeholders to ensure delivery of all assigned medical activities to support life
cycle management, ensuring integrity of scientific content, including copy approval process.
Publishes clinical data in peer review journals and presents in external scientific meetings / congresses; maintains and expands knowledge in medical and scientific competencies (as appropriate), vaccinology and trial methodology.
Collaborate and integrate expertise from cross functional matrix team members and organize key evidence for early product planning, global technology assessment analysis, clinical development through to evidence compendia which consistently support the IEP and value proposition for access/reimbursement decisions.
Performing cell culture development activities for recombinant vaccine antigens or viruses used for clinical and commercial development of vaccine candidate manufacturing processes; providing assistance in the execution of analytical methods in support of purification development for viral vaccines.
Collaborate with data services team to provide requirements and direction to enable the enterprise to leverage web and application data for advanced problem solving, information consumption and insight generation.
Coordinate early interactions with key authorities to obtain input on clinical, technical and/or non-clinical development strategy and, as appropriate, on the optimal regulatory pathway to follow to secure registration and/or approval of regulatory submissions for the given asset(s).
Ensure global alignment to evidence generation and commercial strategies; leads the interpretation, translation and integration of medical voice of customer (patients, providers, payers) into medical affairs strategy and prioritizes patient's benefit and welfare.