Vice President – Program Management

🔥 6 minutes ago

🐊 Florida, South Dakota – Remote

🐊 Florida – Remote 🗿 South Dakota – Remote

⏰ Full Time

🔴 Lead

📋 Program Manager

👻 Ghost score 12%

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SAB BIO

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

SAB BIO is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency human immunoglobulin G (hIgG) therapies to treat and prevent immune and autoimmune disorders, with a stated mission to redefine diagnosis and treatment of type 1 diabetes (T1D) through disease-modifying medicines. Founded in 2014 and traded on Nasdaq (SABS) since 2021, SAB BIO uses proprietary genetic engineering and antibody technologies to generate therapeutic candidates without relying on human donors or convalescent plasma. The company has conducted seven clinical trials dosing roughly 700 individuals across multiple therapeutic areas, reporting no patients with serum sickness or neutralizing anti-drug antibodies in its safety and immunogenicity database. Its lead candidate, SAB-142, is aimed at delaying onset and potentially preventing progression of Stage 3 T1D.

📋 Description

• Lead and develop SAB’s Program Management function • Establish effective program governance, processes, and accountability • Serve as senior program leader for SAB-142 through late-stage development, BLA preparation and submission, regulatory review, approval, and launch readiness • Drive cross-functional execution across Clinical, Regulatory, CMC, Manufacturing, Quality, Supply Chain, Finance, and Commercial Operations • Establish and maintain the integrated development and commercialization plan for SAB-142 • Align timelines, resources, budgets, risks, and critical milestones • Develop and maintain integrated development and pre-commercialization R&D and Medical Affairs plans • Drive readiness for BLA submission, regulatory review, inspections, commercial manufacturing, and product launch • Partner with functional leaders to ensure alignment and timely execution • Coordinate activities and deliverables across CDMOs, CROs, laboratories, consultants, and other external partners • Identify risks, gaps, constraints, and interdependencies and develop mitigation and contingency plans • Establish decision-making and escalation processes and resolve critical cross-functional issues • Provide executive leadership with concise, decision-ready program updates • Oversee program budgets, resource planning, and forecasting with Finance and functional leaders • Support regulatory and commercial readiness, BLA preparation timelines, inspection readiness, manufacturing readiness, and launch planning • Support strategic partnerships, business development, due diligence, and alliance activities • Build, mentor, and lead the Program Management organization • Directly manage program management staff and indirectly lead cross-functional internal and external teams • Foster accountability, collaboration, urgency, transparency, and disciplined execution

🎯 Requirements

• Advanced degree in life sciences, pharmaceutical sciences, engineering, or a related discipline • PhD, PharmD, MBA, or equivalent advanced training preferred • 15+ years of progressive experience in the biopharmaceutical industry • Significant experience in biologics development and late-stage programs • 10+ years’ direct experience as a PM leader managing development programs for new molecular entities or biologics • Demonstrated PM experience in R&D and Medical Affairs programs • Verifiable experience leading PM efforts for at least 2 BLA/NDA submissions, with at least one being in the past 5 years • Experience leading PM activities across complex cross-functional programs through late-stage development, BLA preparation/submission, regulatory review, approval, and/or commercial launch • Strong understanding of biologics development, including CMC, manufacturing, analytical development, process validation, comparability, stability, and commercial readiness • Working knowledge of FDA CBER and global regulatory expectations, including EMA and MHRA • Experience with biologics, immunotherapies, immunoglobulins, recombinant proteins, plasma-derived or other complex biologic products strongly preferred • Demonstrated ability to lead internal teams and external partners, including CDMOs, CROs, consultants, and testing laboratories • Proven ability to manage complex timelines, budgets, resources, risks, and executive-level communications • Strong business acumen and ability to translate complex technical and regulatory issues into practical business decisions • Excellent leadership, communication, facilitation, negotiation, and problem-solving skills • Ability to influence across functions and drive results in a collaborative, resource-conscious environment • Experience working in a small or emerging biotech environment strongly preferred • Experience supporting commercial readiness, product launch, board-level reporting, strategic partnerships, or alliance management preferred • Ability to walk, stand, sit, and regularly lift or move up to 10 pounds • Expected to work extended hours including evenings, weekends, and holidays based on business demands • Citizenship or employment eligibility information required in the application

🏖️ Benefits

• Remote, home office work environment • Regular travel to SAB’s physical office locations • Reasonable accommodations in compliance with the Americans with Disabilities Act of 1990 • Equal employment opportunity and non-discrimination commitment

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