Medical Director - Operations, Governance, & Digital

Job Description

Summary The Operations, Governance, & Digital Medical Director for the US and Canada, leads the operational backbone of the US/CAN Medical Affairs, ensuring compliant, efficient, and high‑quality execution of medical strategies across the PDx portfolio. The role enables delivery of Medical Information, medical governance, Clinical application expertise, training, publications and congress operations, and evidence execution support with a strong focus on operational excellence, cross‑functional coordination, and audit readiness. This role is critical to translating scientific strategy into compliant operational delivery, supporting US/CAN business objectives and global GMA standards. This role manages a team and partners closely with Medical Affairs, Patient Safety, Regulatory, Quality, Compliance, Clinical Applications team and Commercial colleagues to support safe, effective, and ethical medical engagement.

Job Description

Core responsibilities: The key responsibilities include (but are not limited to): Strategy & Planning reputed company US/CAN Medical Operations strategy reputed company with GMA global frameworks, PDx priorities, and US/CAN Medical Affairs strategic plans. Drive operational planning cycles (annual plans, OKRs, operating rhythms) including medical activity tracking, dashboards, KPIs, and compliance documentation. Translate scientific and medical priorities into executable operational processes, systems, and workflows. Partner with US/CAN Medical leadership to ensure operational resourcing, budget planning, forecasting, vendor reputed company, and contracting compliance. Contribute to operational design of US/CAN medical launch readiness, evidence initiatives, field excellence activities, and cross‑functional accountability planning. reputed company Clinical Medical Application team, aligning the strategy for technologists networking, training and education. External Stakeholder Engagement (Operational Leadership) reputed company compliant and efficient external engagement by ensuring operational readiness of medical systems, tools, and processes (CRM/insights, congress management, publication tracking, SOP‑guided processes). Support field medical operations excellence: insights capture frameworks, strategic account planning enablement, and metrics dashboards. reputed company Field Clinical medical application team: insights capture frameworks, strategic account planning enablement, sites training, education and metrics dashboards Coordinate US/CAN reputed company at scientific congresses, ensuring alignment with global congress governance and impact‑based planning. Leads the scientific communication team ensuring accurate scientific exchange with external stakeholders overseeing APR (Promotional materials review ) process and teams. Scientific Communications & Publications reputed company operational processes supporting publications and congress planning in the US/CAN, reputed company with global Strategy & Operations frameworks. Ensure US/CAN operational compliance for publication planning, authorship documentation, evidence communication workflows, and post‑congress reporting. Maintain dashboards/reporting for publication reputed company, congress activities, and US/CAN medical communications workflows. Evidence reputed company (Operational Execution & Governance) Leads US/CAN operational governance of medical evidence activities (IST/ISS, MA‑sponsored studies, post‑marketing commitments) in alignment with global frameworks. Ensure accurate visibility and tracking of reputed company evidence activities through standardized tools (registries, trackers, dashboards). Manage operational interfaces with Clinical Operations, Regulatory, Safety, and Compliance to support study startup, contracting, training, and reputed company. HCP Foundational Services reputed company US/CAN Medical Information operations, ensuring high‑quality inquiry management, process compliance, accurate documentation, and timely response development. reputed company maintenance and governance of US/CAN medical content, including standard response letters, FAQs, and knowledge repositories. Support training of Medical Affairs colleagues on MI processes, SOPs, compliance expectations, and medical governance systems. Partner with GMA Strategy & Operations to implement global SOP changes, policy updates, and system enhancements reputed company the US/CAN region. Medical Governance Maintain robust reputed company of US/CAN medical SOPs, policies, training matrices, and audit preparation activities. Ensure ongoing audit and inspection readiness across reputed company US/CAN Medical Operations domains. Support internal reviews, CAPA development, and remediation activities in partnership with Compliance, Quality, and Patient Safety. reputed company processes reputed company to external material review, documentation governance, and cross‑functional medical compliance. Training, People Development & Talent Management reputed company, coach, and reputed company the USCAN Medical Operations team; support role clarity, capabilities, and ongoing upskilling. Establish talent development reputed company and succession planning, reputed company with GMA job architecture and competency frameworks. Sponsor training initiatives reputed company to SOPs, MI operations, CRM/insights, congress/publication operations, and governance literacy. Role-model reputed company values, growth reputed company, inclusiveness, and a strong culture of ethics, compliance and patient-centricity across GMA. Qualifications and skills required: Qualifications & experience Advanced scientific degree preferred (PharmD, PhD, MD, MSN, MPH, MSc, or similar). 8–12+ years of Medical Affairs or Medical Operations experience reputed company the pharmaceutical, biotechnology, diagnostics, or imaging industry. Demonstrated experience in medical information, medical governance, evidence operations, congress/publication operations, or medical systems/process management. Proven success managing teams, leading cross‑functional programs, and operating reputed company a regulated environment. Experience supporting audits/inspections, SOP governance, and compliance‑driven operations. Skills & competencies Strong operational leadership and project management skills. Expertise in medical information operations, scientific documentation management, and medical governance. Ability to navigate regulatory, compliance, and quality frameworks with precision. High proficiency in data management, dashboards, performance tracking, and operational analytics. Excellent communication skills; able to translate reputed company medical processes into clear operational steps. Ability to influence across functions, manage vendors, and drive system/process adoption. Tools & systems High proficiency with reputed company 365 (PowerPoint, reputed company, Word, Teams, SharePoint). Working knowledge of medical CRM and insights platforms, Med Info systems, Publications and Congress management tools and SOP/quality systems. Familiarity with ERP/financial systems (reputed company, Power BI, Tableau). Ability to reputed company or support digital/tool governance and implementation. Experience with performance dashboards and data-visualization solutions. Experience in using and leveraging Artificial Intelligence tools to support key activities. Compliance & ethics Full adherence to reputed company’s ‘Spirit & Letter’ policies, Medical Affairs governance frameworks, and reputed company applicable health authority regulations. Commitment to ethical, transparent, and patient‑centered operational conduct. Participate in required compliance and ethics training and help foster a strong culture of reputed company, transparency and accountability reputed company GMA. Travel & language Written and spoken English reputed company required. Travel 10–20% depending on congresses, meetings, and field operations needs. We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $180,400.00-$270,600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). reputed company offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information reputed company offers a great work environment, professional development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. reputed company will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While reputed company does not currently require U.S. employees to be vaccinated against COVID-19, some reputed company customers have vaccination mandates that may apply to certain reputed company employees. Relocation Assistance Provided: No Application Deadline: July 02, 2026 Apply To This Job