Program Manager (SME) - Medical Affairs

Apptad; United States; Remote; USD 150,000 - 190,000; Full time

Job summary

Apptad is seeking a Program Manager and Medical Affairs SME to lead an AI-enabled Evidence Generation platform. You will bridge client stakeholders and internal Product, Data, and AI teams, translating IITs, non-interventional studies, and Phase IV research into actionable roadmaps.

The role requires 10+ years in life sciences, deep Medical Affairs and Real-World Evidence expertise, and experience with data platforms, regulatory standards, and AI governance.

Qualifications

• Education in Life Sciences, Pharmacy, Medicine, Public Health, or related field.
• 10+ years in pharma, biotech, CROs, or life-sciences consulting.
• Deep domain mastery in Medical Affairs and Real-World Evidence.
• Experience leading global pharma programs and executive governance.
• Proven data, analytics, and AI governance experience.

Responsibilities

• Define and lead Integrated Evidence Planning across IITs and observational studies.
• Oversee end-to-end roadmap, dependencies, and cross-functional delivery.
• Lead governance forums, RAID, and SOW scoping.
• Design data architectures and AI guardrails for HITL and explainability.
• Drive adoption with SOPs and training for ClinOps and Medical Affairs.

Skills

Medical Affairs

Evidence Generation

AI/ML

GxP

Program Leadership

Education

Bachelor's or Master's in Life Sciences / related field

Tools

Jira

Confluence

Job description

Title: Program Manager - Medical Affairs (Evidence Generation)

Location: Remote (Client-facing; New Jersey preferred)

Target Profile: Medical Affairs Subject Matter Expert (SME) specializing in Evidence Generation and downstream scientific/commercial evidence consumption.

The Opportunity

Our client is seeking a Program Manager & Medical Affairs SME to lead an AI-enabled Evidence Generation platform. Acting as the primary bridge between pharmaceutical client stakeholders and internal Product, Data, and AI engineering teams, you will translate scientific workflows across Investigator-Initiated Trials (IITs), research collaborations, non-interventional studies, and Phase IV research into a compliant, executable roadmap.

Key Responsibilities

Medical Affairs & Evidence Generation

• Domain Strategy: Serve as the principal SME for Integrated Evidence Planning (IEP), IITs, observational studies, registries, and Phase IV research.
• Workflow Design: Lead stakeholder workshops to define future-state workflows, Scientific Review Committee (SRC) evaluation models, and decision-grade requirements.

Program & Governance Leadership

• Delivery Ownership: Manage the end-to-end roadmap, scope, dependencies, resources, and phased rollouts across external client and internal cross-functional teams.
• Executive Governance: Lead steering committees, status reporting, and RAID management while supporting procurement and Statement of Work (SOW) scoping.
• Data, Analytics & AI Delivery
• Data Architecture: Define ingestion specs, metadata models, lineage, and quality controls for structured and unstructured Medical Affairs data.
• AI Guardrails: Guide AI capabilities for study feasibility and scientific merit scoring-establishing human-in-the-loop (HITL) controls, explainability, and anti-hallucination safeguards.
• Validation: Oversee prototype reviews, UAT, system validation, and post-launch performance monitoring.

Adoption & Expansion

• Change Management: Deliver SOPs, training guides, and demos to drive adoption across ClinOps and Medical Affairs teams.
• Growth: Identify expansion opportunities into new therapeutic areas and clinical-development use cases.

Qualifications:

Education: Bachelor's or Master's in Life Sciences, Pharmacy, Medicine, Public Health, Epidemiology, or Clinical Research (advanced scientific/clinical degree preferred; CS/IT degrees considered with extensive Medical Affairs experience).

Experience:

10+ years in pharma, biotech, CROs, healthcare consulting, or life-sciences technology.

Domain Mastery:

Proven expertise in Medical Affairs, Real-World Evidence (RWE), post-marketing research, IITs, non-interventional studies, and SRC processes.

Program Leadership:

Track record leading complex global pharma programs, executive governance forums, and senior client engagements.

Regulatory & Data Fluency:

Working knowledge of life-sciences data platforms, analytics, and regulated-system standards (GxP, data integrity, privacy, auditability, and AI governance).

Preferred

• Experience deploying AI/ML/GenAI solutions in Medical Affairs or clinical research, including HITL validation and model monitoring.
• Familiarity with Integrated Evidence Planning, real-world data (RWD), and unstructured document extraction.
• Background in life-sciences consulting or enterprise software delivery using Agile (Jira/Confluence).
• PMP, PgMP, or SAFe certification; willingness to travel to client sites as needed.

Success Measures & Competencies

Success Measures

Alignment:

Unified roadmap linking Medical Affairs goals to technical architecture | Predictability: On-scope execution with rigorous RAID and dependency control

AI Trust:

Validated, traceable, hallucination-free outputs for scientific decisions | Adoption: High user uptake and expansion across therapeutic areas

Core Competencies

Domain Authority:

Deep fluency in Evidence Generation & consumption | Executive Presence: Trusted-advisor credibility with senior stakeholders

Structured Agility:

Decisive execution in complex, evolving environments | Governed Innovation: Balancing AI innovation with strict GxP rigor.