Key Responsibilities and Required Skills for Associate Medical Director

🎯 Role Definition

The Associate Medical Director (AMD) is a mid‑senior level medical affairs and clinical development leader responsible for providing clinical and scientific leadership across product development, lifecycle management, safety surveillance, and stakeholder engagement. The AMD partners cross‑functionally with clinical operations, regulatory, pharmacovigilance, commercial, HEOR, and R&D to develop and execute medical strategies that ensure patient safety, scientific integrity, regulatory compliance, and successful product adoption. This role requires an ability to interpret clinical data, author medical communications, support regulatory submissions, manage KOL relationships, and mentor medical affairs colleagues.

📈 Career Progression

Typical Career Path

Entry Point From:

Medical Science Liaison (MSL) with therapeutic area expertise and field experience
Medical Affairs Manager or Medical Advisor with product lifecycle exposure
Clinical Development Physician or Clinical Program Lead involved in trial design

Advancement To:

Medical Director / Senior Medical Director
Head of Medical Affairs
Clinical Development Lead / VP, Clinical Development

Lateral Moves:

Safety Physician / Pharmacovigilance Lead
Medical Writing & Publications Lead
HEOR & Market Access Medical Lead

Core Responsibilities

Primary Functions

Develop and execute the product-specific medical strategy and tactical plans that align with the overall corporate and commercial objectives, ensuring clear scientific positioning and evidence generation priorities across pre‑ and post‑marketing lifecycle stages.
Serve as the medical lead for assigned therapeutic area(s), providing clinical expertise to cross‑functional project teams (clinical, regulatory, commercial, safety, and legal) to ensure medically accurate, compliant and commercially relevant decisions.
Oversee design, implementation and medical monitoring of clinical trials and observational studies, including protocol development, site selection input, clinical endpoints, and safety monitoring plans in alignment with GCP and regulatory expectations.
Act as medical reviewer and approver for promotional and non‑promotional materials, ensuring scientific accuracy, regulatory compliance, and alignment with approved labeling and medical strategy.
Lead safety surveillance and signal detection activities for assigned products in collaboration with pharmacovigilance; contribute to periodic safety reports (PSURs/PBRERs), safety risk management plans (RMPs), and post‑marketing commitment programs.
Contribute to regulatory submission packages by authoring or reviewing clinical summaries, benefit‑risk narratives, investigator brochures, and responding to agency queries with high‑quality scientific rationale and supporting literature.
Develop, draft, review and approve scientific publications, abstracts, posters and oral presentations; manage the publications plan to increase scientific visibility and support product value story.
Lead advisory boards, expert panels, and KOL engagements to capture external insights, validate scientific positioning, and inform clinical and commercial strategies while ensuring appropriate compliance and documentation.
Provide medical and scientific input to pricing and market access dossiers, health economic models, and value dossiers in collaboration with HEOR and Market Access to support reimbursement and formulary decisions.
Mentor and coach junior medical affairs colleagues and MSL teams; define training content, competency expectations, and ensure field teams are medically enabled to support scientific exchange.
Provide medical training and scientific education to commercial teams, ensuring accurate interpretation of clinical data, appropriate messaging, and compliant responses to medical inquiries.
Collaborate with clinical operations and CRO partners to ensure high quality data capture, protocol adherence, and timely resolution of clinical study issues including SAE reporting and adjudication processes.
Analyze and synthesize clinical and real‑world evidence to deliver actionable insights, slide decks, and scientific narratives to support internal stakeholders and external engagements.
Support due diligence and lifecycle decision‑making by interpreting clinical data and providing expert input on indications, label changes, and potential new development opportunities.
Provide oversight and quality control for medical writing deliverables including clinical study reports, synopses, investigator brochures, and regulatory briefing documents.
Maintain up‑to‑date expertise in the therapeutic area, competitor landscape, guideline changes, and relevant scientific literature; proactively translate changes into business implications and recommendations.
Ensure compliance with applicable industry codes, company policies, GCP, and local regulatory requirements in all medical activities and external communications.
Represent the company at scientific meetings, congresses and symposia; develop congress strategy, manage abstract submissions and support faculty engagement.
Lead cross‑functional medical input into commercialization planning, including product launch medical plans, field medical support models, and post‑launch evidence generation.
Drive continuous improvement of medical affairs processes and standard operating procedures (SOPs), including quality metrics and governance for medical review and approvals.
Provide medical oversight for compassionate use, expanded access programs and patient support initiatives ensuring ethical standards, documentation and regulatory compliance.
Prepare and present regular medical dashboards and performance metrics to senior leadership to demonstrate progress against medical objectives, safety signals, and evidence generation milestones.

Secondary Functions

Support ad‑hoc medical information requests from internal stakeholders and external healthcare professionals, ensuring timely, evidence‑based responses.
Contribute to cross‑functional working groups (e.g., launch, safety, commercial readiness) and act as the medical representative to provide clinical insight and risk‑benefit rationale.
Participate in investigator selection and feasibility assessments for clinical studies, offering clinical judgment on protocol feasibility and patient population considerations.
Assist in development and review of training materials, SOPs and job aids for field medical teams and clinical staff to ensure consistent scientific communication.
Support management of external vendors (medical writing agencies, publication planners, CROs) to deliver high‑quality outputs on budget and on schedule.

Required Skills & Competencies

Hard Skills (Technical)

Strong clinical knowledge in relevant therapeutic area(s) with demonstrated ability to interpret complex clinical trial data and real‑world evidence.
Clinical trial design and medical monitoring experience, including protocol development, safety escalation, and site interactions.
Pharmacovigilance familiarity: adverse event reporting, signal detection, risk management plans (RMP), and regulatory safety submissions.
Regulatory knowledge: experience contributing to regulatory dossiers, clinical overviews, and responding to health authority queries.
Medical review and compliance: review of promotional materials, medical information letters, and safety communications with knowledge of applicable industry codes and regulations.
Scientific writing and publications management: drafting manuscripts, abstracts, clinical study reports and publication plans.
Health economics & outcomes research (HEOR) collaboration: ability to translate clinical outcomes into value messages and support reimbursement discussions.
Data literacy: ability to read statistical outputs, interpret biostatistical results, and synthesize findings for non‑statistical stakeholders.
Project and stakeholder management: managing timelines, deliverables and cross‑functional alignment across complex medical projects.
Experience with GxP, GCP, ICH guidelines and clinical study quality assurance.

Soft Skills

Excellent written and verbal communication with the ability to present complex medical information clearly to diverse audiences.
Strong strategic thinking and business acumen to align medical plans with commercial and regulatory objectives.
Leadership and people development: mentoring, coaching and motivating cross‑functional teams and field medical staff.
Influencing and negotiation skills to align external KOLs and internal stakeholders around scientific strategies.
Problem solving and critical thinking with a pragmatic, evidence‑based approach to decision making.
High integrity and ethical standards in interactions with HCPs, regulators, and internal teams.
Adaptability and resilience in a fast‑paced, changing clinical and regulatory environment.
Collaboration and teamwork across geographically dispersed and culturally diverse teams.
Detail orientation and quality focus for medical writing and regulatory documentation.
Time management and prioritization to balance multiple competing medical responsibilities.

Education & Experience

Educational Background

Minimum Education:

MD, DO, PharmD, or PhD in a relevant biomedical science field (or equivalent clinical degree with strong clinical research experience).

Preferred Education:

MD or DO with active clinical experience and specialty training in the therapeutic area of responsibility.
Additional training or certification in clinical research, regulatory affairs, or pharmacovigilance is a plus.

Relevant Fields of Study:

Medicine (MD/DO)
Pharmacy (PharmD)
Clinical Epidemiology / Public Health
Life Sciences (PhD)
Regulatory Science / Clinical Research

Experience Requirements

Typical Experience Range: 5–10+ years of progressive experience in medical affairs, clinical development, pharmacovigilance, or related roles within the pharmaceutical, biotech, or medical device industry.

Preferred:

7+ years of industry experience with demonstrated ownership of medical strategy, clinical program involvement, and external KOL engagement.
Experience in managing or mentoring MSLs, medical advisors or small medical teams.
Prior exposure to regulatory interactions and contribution to submission documents (e.g., IND/CTA, NDA/MAA) is strongly preferred.
Demonstrated track record of publications, congress participation and medical communication outputs in relevant therapeutic area.