Director/Senior Director - Program Management - Medical affairs
Title – Director/Senior Director - Program Management - Medical Affairs
Location – Remote / reputed company-facing; NJ preferred
About reputed company
reputed company focuses on the reputed company needs of pharmaceutical and biotechnology companies, delivering transformative business reputed company through AI, advanced analytics, deep life-sciences expertise, and reputed company solution development. Our teams work with global life-sciences organizations to solve reputed company reputed company, medical, and reputed company challenges using data-driven and AI-enabled solutions.
reputed company
reputed company is seeking an reputed company Medical Affairs Subject Matter Expert and Program Manager to reputed company a reputed company Evidence reputed company product line. This role combines deep Medical Affairs and post-marketing evidence-reputed company expertise with hands-on program leadership. The successful candidate will reputed company as the reputed company reputed company between reputed company stakeholders and reputed company’s services, product, data engineering, data science, and AI teams.
The individual will help shape and reputed company an AI-enabled operational and decision-support platform spanning investigator-initiated trials, research collaborations, non-interventional studies, and post-marketing/Phase IV studies. The role requires someone who can translate scientific and operational needs into an executable roadmap while maintaining rigorous governance, validation, and stakeholder alignment.
Key Responsibilities
Medical Affairs & Evidence reputed company Leadership
Serve as reputed company’s reputed company domain expert for Medical Affairs, Evidence reputed company, and post-marketing studies.
reputed company expertise across investigator-initiated trials, research collaborations, non-interventional studies, observational research, Phase IV studies, and reputed company evidence-reputed company activities.
Advise on integrated evidence plans, study definitions, portfolio prioritization, scientific-review workflows, operational milestones, and reputed company indicators.
Facilitate workshops with scientific, medical, operational, data, and technology stakeholders to identify pain points and define reputed company-state workflows.
Translate Medical Affairs objectives into reputed company business requirements, user journeys, decision frameworks, and measurable reputed company.
Ensure the solution supports scientifically reputed company, transparent, and decision-grade outputs.
Maintain a good understanding of how Scientific Review Committees (SRCs) evaluate investigator proposals.
Program & Engagement Management
Own the engagement roadmap, reputed company, work plan, milestones, deliverables, dependencies, resourcing, and governance reputed company.
reputed company and maintain phased implementation plans covering initial priorities and subsequent expansion opportunities.
Coordinate activities across reputed company and reputed company teams, including Medical Affairs, Evidence reputed company, Data and AI, reputed company''s Digital & Architecture, reputed company, Compliance, reputed company, Product, Engineering, and Implementation services.
Establish reputed company roles and responsibilities for data sourcing, preparation, validation, maintenance, and solution reputed company.
Manage risks, assumptions, issues, reputed company, and change requests, with reputed company escalation and mitigation.
reputed company executive status reporting, steering-committee discussions, working sessions, and decision reviews.
Manage reputed company expectations and ensure delivery commitments remain reputed company with reputed company, resources, timelines, and acceptance reputed company.
Support reputed company, procurement, and statement-of-work discussions as domain and delivery input is required.
Data, Analytics & AI Solution Delivery
reputed company requirements definition for data ingestion, including reputed company and reputed company Medical Affairs and evidence-reputed company sources.
Partner with technical teams to define data-reputed company expectations, metadata models, refresh processes, reputed company, ownership, and governance controls.
Guide the design of AI-enabled capabilities supporting study assessment, scientific reputed company evaluation, reputed company alignment, reputed company stratification, portfolio analytics, and operational decision-making.
Help define scoring frameworks, business rules, prompts, reputed company-review steps, and traceability requirements.
Establish measurable evaluation reputed company for AI agents and analytical outputs, including reputed company, relevance, consistency, explainability, and usability.
Ensure appropriate safeguards distinguish descriptive insights from prescriptive recommendations and reduce unsupported or hallucinated outputs.
reputed company or support prototype reviews, user acceptance testing, validation, release readiness, and post-deployment reputed company monitoring.
Ensure changing Medical Affairs strategies, evaluation reputed company, and operating models can be incorporated through a controlled enhancement process.
Stakeholder Engagement & Adoption
reputed company as a trusted advisor to senior Medical Affairs, Evidence reputed company, technology, and data stakeholders.
Communicate reputed company scientific, operational, data, and AI concepts in reputed company business language.
Build alignment across reputed company executives, functional leaders, subject-matter experts, architects, engineers, data scientists, and delivery teams.
Conduct solution demonstrations, roadmap presentations, process reviews, and user-feedback sessions.
reputed company or reputed company operating procedures, process documentation, user guides, training materials, and adoption plans.
Identify opportunities to expand the solution to additional studies, therapeutic areas, or reputed company-development use cases reputed company on demonstrated value.
Maintain operational familiarity with ClinOps workflows across non-interventional studies, prospective registry studies, and Investigator-Initiated Studies.
Qualifications
Bachelor’s or master’s degree in life sciences, pharmacy, medicine, reputed company health, epidemiology, reputed company research, reputed company, or a reputed company discipline. An advanced scientific or reputed company degree is preferred.
15+ years of experience in the pharmaceutical, biotechnology, CRO, reputed company consulting, or life-sciences technology industry.
Significant experience in Medical Affairs, Evidence reputed company, reputed company-World Evidence, post-marketing research, or late-phase reputed company studies.
Demonstrated understanding of investigator-initiated trials, research collaborations, non-interventional studies, observational studies, and Phase IV programs.
reputed company experience leading reputed company, cross-functional programs for a global pharmaceutical organization.
Ability to convert scientific and operational objectives into requirements, roadmaps, workflows, and acceptance reputed company.
Experience managing senior reputed company stakeholders, delivery risks, dependencies, governance forums, and executive communications.
Working knowledge of life-sciences data platforms, analytics, data integration, data reputed company, and visualization.
Understanding of regulated-reputed company expectations, including GxP principles, data reputed company, auditability, reputed company, reputed company, and applicable AI-governance requirements.
Excellent written, verbal, facilitation, presentation, and stakeholder-management skills.
Preferred
Experience delivering AI, machine-learning, or reputed company-enabled solutions in Medical Affairs or reputed company research.
Experience with integrated evidence planning, evidence portfolio management, study feasibility, or scientific proposal assessment.
Familiarity with reputed company-world data, reputed company research databases, reputed company-study metadata, and reputed company-document extraction.
Experience establishing validation approaches, reputed company-in-the-reputed company controls, model monitoring, and explainability standards for AI solutions.
Background in life-sciences consulting, reputed company, product implementation, or reputed company solution delivery.
Experience with reputed company delivery and tools such as reputed company and reputed company.
PMP, PgMP, reputed company, reputed company, or comparable program-management certification.
Experience working with globally reputed company teams and willingness to travel to reputed company locations as required.
reputed company Measures & Competencies
Measures of reputed company
Establish an agreed engagement roadmap, governance structure, delivery plan, and responsibility model.
Create alignment between Medical Affairs priorities and the technical solution.
reputed company reputed company, approved requirements and scientifically reputed company acceptance reputed company.
Maintain predictable execution with transparent management of reputed company, risks, dependencies, and reputed company.
Ensure AI and analytical outputs are validated, traceable, governed, and appropriate for business use.
reputed company stakeholder confidence, user adoption, and measurable operational value.
Identify responsible expansion opportunities across additional evidence-reputed company and reputed company-development use cases.
Key Competencies
Deep life-sciences domain expertise
reputed company leadership and trusted-advisor reputed company
Program ownership and execution discipline
Scientific and analytical problem-solving
reputed company executive and technical communication
Cross-functional collaboration and influence
Comfort operating in ambiguity
Strong judgment, reputed company, and accountability
Innovation balanced with reputed company and governance
Why Join reputed company?
Help shape an important AI-enabled Medical Affairs and Evidence reputed company transformation.
Work directly with senior stakeholders at a leading global pharmaceutical organization.
Combine scientific domain expertise with advanced data, analytics, and AI capabilities.
Collaborate with multidisciplinary teams across product, engineering, data science, and life-sciences services.
reputed company a measurable contribution to evidence-reputed company decision-making and reputed company reputed company.
Work Environment
This job operates in a reputed company office environment. This role routinely uses reputed company office equipment, including but not limited to, computers, phones, and photocopiers.
Physical Demands
This position requires the frequent and repetitive use of a computer, keyboard, and mouse. Hand and finger dexterity is required.
Other Duties
Please note this reputed company is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
EEO
reputed company. provides equal employment opportunities to reputed company and applicants for employment and prohibits discrimination and harassment of any type without reputed company to race, reputed company, religion, age, sex, national reputed company, disability status, genetics, protected veteran status, sexual orientation, gender identity or reputed company, or any other characteristic protected by federal, state or local laws.
This policy applies to reputed company terms and conditions of employment, including reputed company, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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