Senior Advisor - Antibody Development Government Programs

Company: Mapp Biopharmaceutical
Location: San Diego
Posted on: September 14, 2020

Job Description:

San Diego, CA, USAFull Time Senior Advisor Antibody Development Government ProgramsJob #20-07AMapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.The Early Research and Development Group (ER&DG) and the Advanced Research and Development Group (AR&DG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of robust portfolio with the CMC, Pre-Clinical, Regulatory and Clinical development goals consistent with the product development objectives of Mapp.The Senior Advisor of Antibody Development Government Programs has responsibilities as a Principal Investigator and acting as an advisor and Subject Matter Expert (SME) to the development of other government funded antibody programs at Mapp.-- This individual leads a team of employees by aligning discovery and product strategy with execution through integrated development, budget, risk management, scenario development and team performance support. The Sr. Advisor - Antibody Development Government Programs will implement technical and project management integration activities across Discovery, Candidate Selection, and Phases I IV studies relating to upstream development for a given indication and/or product(s) post-candidate development.Basic Qualifications: Ph.D. or equivalent in a scientific discipline15+ years experience in BioProduct and/or Research and Development with a combination of large and small Biopharmaceutical and/or Government organizations10+ years experience in a Government organization leading technical and strategic activities for drug development from concept to licensure10+ years in a supervisory roleDemonstrated ability to lead a biomolecule program through development to licensureDemonstrated success in leading and motivating a team of drug developers to milestone achievementsExperience in a management-level leadership roleExperience in Contracts, Budgets, and GrantsRegulatory (FDA etc.) experience in leading dossiers and/or other regulatory communications for biomoleculesSignificant experience in Neglected Tropical Disease and Biodefense program developmentExperience in managing difficult technical programs for delivery of material to the clinicExperience in managing technical and non-technical budgets and timelinesExperience in the integration of multiple technical disciplines within a biopharmaceutical organization to deliver drugs to the clinicExperience in leading CHO, Microbial or Plant-made-Biopharmaceutical development programs for early, mid- and late-stage candidatesExperience in over-seeing/managing CMC, nonclinical, and clinical product development program integration for bio moleculesAbility to manage multiple tasks and complete priorities in a fast-paced environment while maintaining a flexible demeanorExperience in using standard project management capabilities for drug developmentAbility to speak effectively before groups and individuals including Senior Executive staff and corporate employeesAbility to conduct self in a professional and respectful manner at all times under stressful situationsStrong sense of urgency and the ability to work within deadlines and exhibit an ability to work both independently and in a teamAbility to utilize Word, Excel, Microsoft Outlook, PowerPoint, MS-ProjectAbility to plan and manage work under time constraintsStrong written, verbal and people skillsComfortable conducting day to day activities via teleconferenceStrong organizational skills and keen attention to detail and accuracyAbility to build strong internal and external relationships using effective verbal and written communication skillsAbility to act accordingly to solve problems and resolve unique situations with professionalism and service orientation Preferred Qualifications: Vaccine development Responsibilities Acts as program point of contact for Executive leadership, with responsibility and accountability for delivering a mAb program to developed timelines and budgetProvides leadership and develops/mentors staff internally or at CRO/CMO through effective coaching and developmentLeads and oversees the technical and project management aspects of a mAb development, clinical manufacturing, and commercialization for therapeutic biologics in DevelopmentTakes the lead role in partnering with the Mapp technical team and CRO/CMO teams to establish the development strategy to meet the program Target Product Profile, process development, clinical manufacturing, regulatory, quality, and commercialization needsTakes the lead role in partnering with the other Mapp technical and PM leads to assure that shared learning of the program development plan is appropriately disseminatedAssures the development program plan progresses as it relates to timeline and budget, changes to plan are rationalized and documented, risks are identified, communicated, and tracked, and program reporting expectations, deliverables and requirements are metServes as a Subject Matter Expert (SME) on Mapp's development programs to the Mapp cross-functional team, specifically in response to technical and budgetary queries and managing government interactions as it relates to the development of other assets in the Mapp portfolioCompiles metrics and performs analysis of the budget, in parallel with the timelines for Mapp, in partnership with R&D Ops, Contracts, and executive management Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego, CA or may have the opportunity to work remotely. Willingness to Travel to clinical trial sites (4-6 times per year domestic & 1-2 times per year international) will be required for this position. Mapp wants you to join their team and invites you to apply.No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.Mapp Biopharmaceutical https://mappbio.applicantpro.com

Keywords: Mapp Biopharmaceutical, San Diego , Senior Advisor - Antibody Development Government Programs, Government & Protective Services , San Diego, California