Program specialist Jobs in Sioux Falls, SD

Vice President Of Program Management

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 accountability.
• Serve as the senior program leader for SAB-142, driving execution across internal functions and external partners.
• Develop and maintain integrated development and pre-commercialization R&D and Medical Affairs plans, including critical paths, milestones, dependencies, resources, budgets, and risks.
• Drive cross-functional readiness for major milestones, including BLA submission, regulatory review, inspections, commercial manufacturing, and product launch.
• Partner closely with Regulatory, Clinical, CMC, Quality, Manufacturing, Supply Chain, and Commercial leaders to ensure alignment and timely execution.
• Coordinate activities and deliverables across CDMOs, CROs, laboratories, consultants, and other external partners.
• Identify program risks, gaps, constraints, and interdependencies and develop effective mitigation and contingency plans.
• Establish clear decision-making and escalation processes and ensure timely resolution of critical cross-functional issues.
• Provide executive leadership with concise, accurate, decision-ready program updates, including status, risks, milestones, and resource requirements.
• Oversee program budgets, resource planning, and forecasting in partnership with Finance and functional leaders.
• Support regulatory and commercial readiness activities, including management of BLA preparation timelines, inspection readiness, manufacturing readiness, and launch planning.
• Support strategic partnerships, business development, due diligence, and alliance activities.
• Build, mentor, and lead a high-performing Program Management organization capable of supporting late-stage development and commercialization.
• Foster a culture of accountability, collaboration, urgency, transparency, and disciplined execution.

Education/Experience/Skills

Include but are not limited to:

• 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, with 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 experience 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.
• Leading the 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 where strategic leadership must be combined with hands-on execution strongly preferred.
• Experience 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

Include but are not limited to:

• 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 expected.
• Extended 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