Jobs · Information Technology

Vice President Program Management

SAB BIO · Sioux Falls, SD · 1 mo ago
RemoteRemoteInformation TechnologyFull-time
The Vice President of Program Management (PM) will lead SAB’s PM function and serve as the senior program leader for SAB-142 through its late-stage development, BLA preparation and submission, regulatory review, approval, and launch readiness activities. This role will drive cross-functional execution across Clinical, Regulatory, CMC, Manufacturing, Quality, Supply Chain, Finance, and Commercial Operations. It is expected that the workload will be ~70% focused on BLA readiness/filing and launch readiness PM-related activities with the remaining ~30% being focused on operations related PM activities. Reporting to the COO, the VP PM will establish and maintain the integrated development and commercialization plan for SAB-142, ensuring alignment of timelines, resources, budgets, risks, and critical milestones. The successful candidate will bring strong biologics development experience, sound business judgment, and the ability to translate complex scientific, regulatory, and operational issues into clear priorities and executable plans. Duties and Responsibilities (Include but are not limited to): Lead and develop SAB’s Program Management function and establish effective program governance, processes, and accountabilityServe as the senior program leader for SAB-142, driving execution across internal functions and external partnersDevelop and maintain integrated development and pre-commercialization R&D and Medical Affairs plans, including critical paths, milestones, dependencies, resources, budgets, and risksDrive cross-functional readiness for major milestones, including BLA submission, regulatory review, inspections, commercial manufacturing, and product launchPartner closely with Regulatory, Clinical, CMC, Quality, Manufacturing, Supply Chain, and Commercial leaders to ensure alignment and timely executionCoordinate activities and deliverables across CDMOs, CROs, laboratories, consultants, and other external partnersIdentify program risks, gaps, constraints, and interdependencies and develop effective mitigation and contingency plansEstablish clear decision-making and escalation processes and ensure timely resolution of critical cross-functional issuesProvide executive leadership with concise, accurate, decision-ready program updates, including status, risks, milestones, and resource requirementsOversee program budgets, resource planning, and forecasting in partnership with Finance and functional leadersSupport regulatory and commercial readiness activities, including management of BLA preparation timelines, inspection readiness, manufacturing readiness, and launch planningSupport strategic partnerships, business development, due diligence, and alliance activitiesBuild, mentor, and lead a high-performing Program Management organization capable of supporting late-stage development and commercializationFoster a culture of accountability, collaboration, urgency, transparency, and disciplined execution Supervisory Responsibilities: This position has direct supervisory responsibilities and will be responsible for building-out, leading, and developing the Program Management function. The VP will directly manage program management staff and indirectly lead cross-functional internal and external teams through governance structures, program leadership, and project execution authority. Education/Experience/Skills: Advanced degree in life sciences, pharmaceutical sciences, engineering, or a related discipline; PhD, PharmD, MBA, or equivalent advanced training preferred15+ years of progressive experience in the biopharmaceutical industry, with significant experience in biologics development and late-stage programs10+ years’ direct experience as a PM leader managing development programs for new molecular entities or biologicsDemonstrated experience PM experience in R&D and Medical Affairs programsVerifiable experience leading PM efforts for at least 2 BLA/NDA submissions, with at least one being in the past 5 yearsLeading the PM activities across complex cross-functional programs through late-stage development, BLA preparation/submission, regulatory review, approval, and/or commercial launchStrong understanding of biologics development, including CMC, manufacturing, analytical development, process validation, comparability, stability, and commercial readinessWorking knowledge of FDA CBER and global regulatory expectations, including EMA and MHRAExperience with biologics, immunotherapies, immunoglobulins, recombinant proteins, plasma-derived or other complex biologic products strongly preferredDemonstrated ability to lead internal teams and external partners, including CDMOs, CROs, consultants, and testing laboratoriesProven ability to manage complex timelines, budgets, resources, risks, and executive-level communicationsStrong business acumen and ability to translate complex technical and regulatory issues into practical business decisionsExcellent leadership, communication, facilitation, negotiation, and problem-solving skillsAbility to influence across functions and drive results in a collaborative, resource-conscious environmentExperience working in a small or emerging biotech environment where strategic leadership must be combined with hands-on execution strongly preferredExperience supporting commercial readiness, product launch, board-level reporting, strategic partnerships, or alliance management preferred Physical Demands: While performing the duties of this job, the employee is regularly required to walk, stand, and sit. The employee must regularly lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus. Working Environment and Travel: Remote, home office work environment with regular travel to SAB’s physical office locations (currently in Sioux Falls, SD and Miami Beach, FL)Periodic business travel to SAB partner CDMO’s and other locations is also expectedExtended work hours including evenings, weekends and holidays is expected based on business demands ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990. SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vet Powered by JazzHR nmZkQ1cDc0

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