HiRO provides a professional and culturally enriching environment that enhances the personal and professional growth of our employees. Our goal is to develop competitive medical professionals who contribute to global drug development and help bring innovative treatments to patients in need. At HiRO, our shared values of passion, innovation, trust, and integrity foster a diverse and collaborative workplace. We are committed to supporting our employees in reaching their full potential while driving outstanding results. We respect and celebrate diversity, professionalism, and excellence.
Who We Are Looking For:
Position: Medical Monitor or Associate Medical Director (ANZ-Based)
Reporting To: Chief Medical Officer (CMO), CSMA Team
This role is part of HiRO's global organisation and supports daily operations related to the execution of projects and studies awarded by international sponsors. The Medical Monitor/Associate Medical Director will serve as a subject matter expert in the relevant therapeutic areas required by assigned projects, which may include oncology, general medicine, rare diseases, pediatrics, gynecology, psychiatry, medical devices, diagnostics, radiopharmaceuticals, cell and gene therapy, and vaccines, among others. The broader the experience, the more valuable the candidate.
Key Responsibilities:
Proposal Development & Business Development Support:
* Manage and respond to daily Requests for Proposals (RFPs) received through CRM/BD channels.
* Prepare proposal documents, CVs, experience sheets, and budget proposals.
* Develop presentation materials and participate in business development meetings.
* Engage with clients to understand their needs and align medical expertise with project execution.
Medical Oversight & Study Execution:
* Provide medical expertise and oversight for assigned clinical studies.
* Support investigator site selection, feasibility assessments, and study initiation.
* Conduct safety assessments, including causality evaluations for Serious Adverse Events (SAEs), Adverse Events (AEs), and Suspected Unexpected Serious Adverse Reactions (SUSARs).
* Maintain relationships with key medical experts, clinical sites, and research units.
* Support study execution from initiation to closure, including responding to site inquiries and addressing study-related issues.
Regulatory & Compliance Support:
* Ensure compliance with local (ANZ) and international regulations, including ICH-GCP guidelines.
* Assist in the development and review of medical monitoring plans, protocols, Investigator's Brochures (IBs), Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other regulatory documents.
* Provide input for safety management plans and clinical monitoring plans.
* Participate in Safety Review Committees (SRCs) and interim data review meetings.
Cross-Functional Collaboration:
* Work closely with clinical operations, pharmacovigilance, medical writing, and regulatory teams.
* Support medical training programs for internal teams and external stakeholders.
* Assist in qualification and assessment of vendors, including labs, imaging providers, and AI/data analytics vendors.
* Contribute to strategic initiatives such as joint ventures, licensing, and partnerships.
Performance Tracking & Professional Development:
* Maintain up-to-date project trackers, forecasts, timesheets, and performance review documents.
* Complete required internal and sponsor-assigned training (e.g., Veeva Vault, SOPs).
* Stay informed on industry trends, drug development advancements, and emerging technologies.
* Actively engage in professional development and medical education to maintain expertise in relevant therapeutic areas.
Other Responsibilities:
* Participate in the development of strategic corporate goals and annual business targets.
* Provide mentorship, coaching, and support for new hires and colleagues.
* Maintain a high standard of integrity, scientific excellence, and compliance in all aspects of work.
Qualifications & Experience:
* Indepth experience within the pharmaceutical, biotechnology, or contract research organization (CRO) industry in Australia or New Zealand.
* Medical Doctor (MD) qualification with years of clinical practice experience preferred; Master's or PhD is advantageous.
* Experience in drug development, hands‐on clinical monitoring for Phase 1‐4 studies, post‐marketing studies, and real‐world evidence (RWE) studies.
* Experience in cell therapy, gene therapy, radiopharmaceuticals, and novel therapeutic modalities is welcome.
* Experience with pediatrics, neuroscience, rare diseases, infectious diseases, vaccines, biologics, and small molecules is highly desirable.
* Familiarity with regulatory approval processes in Australia (TGA), New Zealand (Medsafe), and other international agencies is a plus.
* Knowledge of Australian and New Zealand drug safety reporting requirements.
* Strong communication, collaboration, and presentation skills.
* Ability to work in a dynamic, multicultural, and cross‐functional environment.
This role offers an exciting opportunity to be at the forefront of global drug development while contributing to HiRO's mission of advancing innovative treatments for patients worldwide. If you are a dynamic medical professional with a passion for clinical research, we invite you to apply and join our team.
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