Job Information
Actalent Director Of Medical Monitoring in Piscataway, New Jersey
Director of Medical Monitoring
We are seeking a highly qualified Director of Medical Monitoring to oversee the medical aspects of our clinical studies. This role ensures subject safety, site compliance with protocols and ICH-GCP requirements, and maintains the scientific integrity and quality of clinical studies conducted in the US.
Roles and Responsibilities:
Medical Leadership and Scientific Input:
- Provide proactive medical leadership and scientific input to enhance project quality across medical science, pharmacovigilance, clinical operations, and data management.
Medical Science and Clinical Operations:
Offer clinical and scientific expertise in the development of clinical trial protocols.
Support medical strategies from IND to NDA for client products.
Develop MMP/SMP.
Provide medical support for monitoring guidelines, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, and medical data review planning.
Conduct medical reviews for AE coding, lab data, medical history, and concomitant medications.
Assess subject eligibility.
Support the clinical operations team with medical queries and emergencies.
Review protocol deviations and ensure medical compliance.
Train teams on therapeutic areas, protocols, and other medical topics.
Participate in SRC and IDMC activities.
Support regulatory activities, including IND and NDA/BLA submissions and discussions.
Pharmacovigilance and Data Management:
Review serious and non-serious adverse events to support drug safety activities.
Conduct medical reviews of assigned cases, including narrative review, coding (e.g., MedDRA), and assessment of adverse events and drug reactions.
Perform weekly reviews of non-serious line listings for potential upgrades to serious events.
Write medical queries and conduct similar event analyses, providing causality assessments.
Review aggregated reports (e.g., patient profiles, line listings, IND Annual Safety Reports, DSUR, and RMP) for product safety profiles.
Assess safety issues in clinical trials and escalate them as necessary.
Review and utilize clinical trial protocols, product information, and other relevant documents.
Provide input to project-specific procedures and participate in related meetings.
Communicate with clients as outlined in project-specific procedures.
Assist in the preparation and conduct of coding conventions.
Potentially support site calls, providing product-related information and assessing reported adverse reactions.
Reconcile SAE data between clinical and safety databases.
Lead IDMC reviews and signal detection analyses.
Skills:
- Oncology, Medical Affairs, Clinical Research, Drug Safety, Clinical Trials
Management Responsibilities:
Identify and improve medical monitoring and safety assessment processes.
Develop department or cross-functional SOPs, policies, and guidelines.
Manage employees within the MM/Safety Physician department, assigning and coordinating projects.
Oversee internal training courses related to MM/Safety Physician roles.
Provide on-the-job training to MM/Safety Physicians.
Participate in and support business development activities.
Requirements:
Medical degree.
10-15 years of industry experience in pharmaceutical or CRO companies, with over 5 years in management leadership positions.
Proficient in clinical research and protocol design, with experience in Phase I-III clinical trials.
Familiar with regulatory requirements such as Good Clinical Practice (GCP).
Strong strategic thinking, planning, and operational skills.
Ability to analyze complex situations and provide effective solutions.
Fluent in written and spoken English.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.