Sr. Program Manager

Sr. Program ManagerWe are seeking an experienced Senior Program Manager to oversee and drive cross-functional development programs for small molecule therapeutics. This role will provide leadership and coordination across CMC, non-clinical, clinical, and regulatory functions, ensuring that programs are executed on time, within budget, and in compliance with global regulatory standards.The Senior Program Manager will serve as the primary point of accountability for assigned programs, leading integrated teams, and reporting progress and risks to executive leadership. The ideal candidate brings broad drug development expertise, strong organizational skills, and the ability to influence and motivate diverse stakeholders to achieve program goals.Roles and responsibilities include:Leading cross-functional teams through all stages of small molecule drug development, from preclinical through late-stage clinical studiesDriving end-to-end program lifecycle – initiation to closure – ensuring stakeholder alignment and objective clarityOverseeing CMC timelines and deliverable completion for activities that include process development, manufacturing, analytical methods, formulation, stability, and clinical supply readiness across multiple suppliers to ensure that materials are delivered on time and within budgetCoordinating with Nonclinical activities such as toxicology, PK/PD, safety pharmacology, and ADME studies to enable on time regulatory submissionsPartnering with Regulatory Affairs to develop and implement regulatory strategy toward NDA completion and submissionDeveloping and maintaining integrated project plans covering scope, timelines, budgets, resources, and risk management strategiesTracking progress against milestones, anticipating issues, and implementing corrective actions when necessaryProviding clear, concise updates and presentations to executive leadership, governance committees, and external stakeholdersIdentifying and mitigating program risks across technical, regulatory, operational, and financial dimensions.QualificationsBasic qualifications include:Advanced degree in life sciences, pharmaceutical sciences, or related field (PhD, PharmD, MS, or equivalent strongly preferred).Minimum of 8 years of experience in the pharmaceutical/biotech industry, with at least 5 years in program management.Proven track record managing small molecule development programs through IND-enabling studies and clinical phases to NDA Submission.Experience with CMC, regulatory submissions, clinical operations, and non-clinical activities.Strong understanding of the drug development lifecycle, from discovery through commercialization.Familiarity with global regulatory requirements (FDA, EMA, ICH guidelines) and compliance standards (GxP).Advanced program management skills with experience in budgeting, forecasting, and scenario planning.Ability to communicate complex issues clearly to both technical teams and executive leadership.Strategic thinker with excellent problem-solving, organizational, and risk management capabilities.Strong interpersonal skills with a demonstrated ability to influence without authority to deliver broad impactExperience working with senior leadership and presenting to executive stakeholdersExcellent written and verbal communication skills; able to synthesize complex topics into clear, actionable plansHighly motivated, detail-oriented, and adaptable in fast-paced, dynamic environmentsPreferred qualifications include:Prior experience in biopharmaceutical launchProject Management Professional (PMP) certification is preferred.Knowledge of Design Controls under US and International Regulations preferred.Proven ability to think strategically, plan and align product development with business goals and market needs.Naturally accountable, a self-starter, self-motivated, self-directed, self-sustaining.Outstanding communication and presentation skills, written and verbal, to all levels of an organization.