Director of Medical Affairs

AP MAX INC•Houston, TX

23h

About The Position

The Director of Medical Affairs provides strategic and operational leadership for the organization’s medical affairs function, supporting sterile and nonsterile compounded preparations. This individual serves as the senior medical and scientific authority for internal teams and external healthcare professionals and ensures that clinical information, education, and scientific communications are accurate, evidence-based, balanced, and compliant. The Director will develop the medical affairs strategy, oversee medical information activities, lead clinical education, establish medical review and governance processes, and partner with Pharmacy Operations, Quality, Compliance, Regulatory Affairs, and executive leadership. This position is also responsible for building and developing the medical affairs team and ensuring continued readiness for inspections, audits, and changes in applicable standards.

Requirements

Doctor of Pharmacy degree from an accredited school of pharmacy.
Active pharmacist license in good standing.
Minimum of seven years of relevant experience in medical affairs, medical information, clinical pharmacy, pharmaceutical services, or compounding pharmacy.
At least three years of leadership or people-management experience.
Strong knowledge of sterile and nonsterile compounding and the associated regulatory and quality environment.
Demonstrated ability to critically evaluate and synthesize scientific and clinical literature.
Experience developing medical information resources, clinical policies, educational programs, or scientific communications.
Strong understanding of medical governance, documentation, compliance, and risk-management principles.
Excellent written, verbal, presentation, and stakeholder-management skills.
Demonstrated ability to lead cross-functional initiatives and manage multiple priorities.

Nice To Haves

Experience working in a compounding pharmacy, outsourcing facility, specialty pharmacy, pharmaceutical company, or healthcare organization.
Working knowledge of USP <795>, <797>, and <800>, as applicable.
Experience supporting regulatory inspections, accreditation surveys, quality investigations, or compliance audits.
Experience building or expanding a medical affairs or medical information function.
Experience reviewing clinical, educational, or promotional materials.
Board certification or other advanced clinical credentials.
Experience with adverse-event assessment, product complaints, medication-error review, or safety surveillance.

Responsibilities

Develop and execute the organization’s medical affairs strategy in alignment with clinical, operational, quality, compliance, and business objectives.
Establish the structure, priorities, policies, and standard operating procedures for the medical affairs function.
Serve as the organization’s senior medical and scientific advisor on matters involving sterile and nonsterile compounded preparations.
Provide medical leadership and evidence-based recommendations to executive leadership and cross-functional teams.
Recruit, lead, mentor, and evaluate medical affairs personnel, including pharmacists and medical information professionals.
Establish departmental goals, performance measures, staffing plans, and resource requirements.
Maintain appropriate independence of medical and scientific decision-making from commercial influence.
Oversee the intake, evaluation, documentation, and response process for medical and clinical inquiries.
Ensure responses are accurate, timely, evidence-based, appropriately referenced, and tailored to the requester’s scope of practice.
Provide oversight for complex inquiries involving: Formulation rationale and excipient selection, Dosing, administration, and route-specific considerations, Stability, beyond-use dating, and storage requirements, Sterility assurance and risk-based clinical decision-making, Safety, contraindications, drug interactions, and special populations, Clinical considerations when commercially available products do not meet an individual patient’s needs.
Develop and maintain standard response documents, clinical FAQs, scientific summaries, literature reviews, and reference guides.
Establish escalation procedures for inquiries requiring input from Pharmacy Operations, Quality, Compliance, Regulatory Affairs, or legal counsel.
Analyze inquiry trends to identify safety signals, knowledge gaps, educational needs, and opportunities for operational improvement.
Establish medical review processes for clinical, educational, and externally facing scientific materials.
Ensure medical content is accurate, balanced, substantiated, and consistent with applicable requirements and organizational policies.
Chair or participate in clinical governance, formulary, quality, safety, or risk-management committees, as appropriate.
Provide medical oversight for the evaluation of new formulations, therapeutic areas, clinical services, and strategic initiatives.
Define standards for literature evaluation, evidence grading, scientific referencing, and medical content approval.
Ensure clear separation between scientific exchange and promotional communications.
Develop and oversee comprehensive medical and clinical education programs for pharmacists, pharmacy technicians, customer-facing teams, leadership, and other relevant personnel.
Ensure training addresses: Sterile and nonsterile compounded preparations, Therapeutic areas supported by the organization, Appropriate clinical use and patient-specific considerations, Formulation rationale and beyond-use dating, Safety, contraindications, and risk considerations, Requirements governing compliant scientific communication.
Lead or oversee clinical updates, professional presentations, lunch-and-learns, onboarding programs, and continuing education activities.
Establish methods for documenting training completion and assessing comprehension and effectiveness.
Ensure training materials are reviewed and updated when clinical evidence, regulations, standards, or organizational procedures change.
Maintain current knowledge of laws, regulations, accreditation requirements, and professional standards affecting sterile and nonsterile compounding.
Monitor developments involving applicable USP chapters, FDA guidance, state boards of pharmacy, and accreditation organizations.
Translate new or revised requirements into clear clinical guidance, medical content, and training.
Partner with Quality and Compliance to promote consistent interpretation and implementation of applicable requirements.
Support inspection and audit readiness by ensuring medical affairs documentation, training, and processes are current and complete.
Participate in investigations, corrective and preventive actions, risk assessments, and responses to inspection or audit findings when medical or clinical input is required.
Escalate potential patient-safety, regulatory, ethical, or compliance concerns promptly through established channels.
Collaborate with Quality, Compliance, and Pharmacy Operations on adverse-event reports, product complaints, medication errors, and other potential safety concerns.
Ensure medical assessments and follow-up activities are completed and documented in accordance with established procedures.
Evaluate aggregate medical information and safety data for emerging trends or potential risks.
Recommend risk-mitigation measures, educational interventions, or process improvements when appropriate.
Represent the organization at medical, pharmacy, and industry conferences.
Lead compliant scientific exchange with pharmacists, prescribers, researchers, and other healthcare professionals.
Develop and maintain credible professional relationships with key clinical stakeholders and subject-matter experts.
Gather and communicate relevant medical insights from external engagements to inform clinical education, operations, quality initiatives, and organizational strategy.
Ensure external engagements are appropriately documented and conducted in accordance with applicable policies.