Sr. Director Medical Monitoring
Integrated Resources, Inc
Title: Sr. Director Medical Monitoring
Duration: 7 months+
POSITION SUMMARY :
Provides oversight of medical monitoring activities that span across the clinical trials that are being conducted by Pharmaceuticals. This position serves as Medical Monitoring Subject Matter Expert (SME) for clinical studies and provides oversight of contract medical monitors, helping to ensure the safety and well-being of clinical trial subjects. Also serves as a critical conduit helping to ensure effective communications between stakeholders including sites, CROs, CRAs, Clinical Development, and Medical Safety and Pharmacovigilance (MSPV).
This role reports to the Senior Vice President of Clinical Development or their designee.
CORE ACCOUNTABILITIES :
The successful candidate must be able to perform each of the following satisfactorily.
Major Responsibilities Include:
- Medical Monitoring (MM) oversight for ongoing clinical trials to ensure the safety and well-being of study subjects.
- Ensure that appropriate “day-to-day” medical monitoring activities (e.g. medical data documentation/review) occur consistent with protocols, SOPs, GCPs, and other requirements to support regulatory filings.
- Serve as the Medical Monitoring Subject Matter Expert (SME), providing support to CROs, CRAs, and internal groups/stakeholders (through ad hoc and scheduled cross-functional meetings, etc.).
Key Activities & Responsibilities:
- Provide medical support towards the development and execution of clinical trials including:
- Protocol development
- Training related to the study protocol, ICF, and IB
- The review of safety data
- Interpretation of trial results with emphasis on patient safety
- Support finalization of the clinical study report and other documents (e.g. DSMB charter, RMP, SAP, IB, ICF, reports to Health Authorities, etc.).
- Support responses to Health Authorities (audits, inspections, requests), IRBs, Ethics Committees, etc.
- Aggregate blinded safety data review
- Automated tools for use in medical data review & safety analysis
- Contribute to and/or author MM related documents including budgets, Medical Monitoring contracts and plans (e.g. Medical Monitoring Plans – MMPs, and Medical Data Review Plans – MDRPs).
- Collaborate with cross-functional teams (internal and external staff) to address medical and safety issues in real time (e.g. protocol deviations, inclusion/exclusion criteria, lab alerts, hepatic safety issues, IP interruption, dose modification, rechallenge).
- Work with Clinical Operations and others to help identify significant safety issues that may impact overall project plans and initiate contingency plans as appropriate (e.g. subject retention strategies).
- Maintain close cooperation with the Medical Safety Pharmacovigilance team to support Safety Evaluation & Risk Management (e.g. support the interpretation of medical safety issues and provide regular safety updates from ongoing trials).
- Oversight management of vendors such as CRO’s, CRA’s, Labs etc.; ensure compliance with MM related SOPs, regulations, and support CAPA/deviation management.
- Oversight of CRO Medical Monitors and their support for sites; review MM communication logs, evaluation of CRO MM performance, coaching and mentoring.
- Oversight of medical data review by CRO’s to ensure that line listings, queries, IP decisions, lab alerts, periodic reviews etc. are being managed (meeting quality and timeliness criteria per the MDRP and archived as directed; e.g. eTMF) and escalated as appropriate by CRO MMs.
- Contribute to departmental resource planning, budgeting and timeline setting to meet company needs.
- Ensure appropriate resource planning, e.g., Medical Monitors, Research Scientists, CRAs, etc., are assigned to adequately support current and upcoming clinical trials.
- Provide medical support via cross-functional collaborations into the product strategy and development program (e.g. CSR reviews, DMC reviews, and other adjudication committees, etc.).
- Identify the gaps in medical monitoring oversight management and contribute to continuous/process improvement.
- Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team.
- Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients and customers as our top priorities.
- Other duties as assigned.
- MD degree with a minimum of 7 years of biotechnology or pharmaceutical industry experience in Clinical Research / Medical Monitoring.
- Prior clinical experience in Hepatology, Gastroenterology, Endocrinology/Diabetes, Cardiovascular/Lipidology or related field, preferred.
- Prior industry experience as a medical monitor contributing to the preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents. Prior industry experience with interactions and support of Pharmacovigilance, Medical Affairs and Clinical Trial monitoring activities.
- Management experience; prior responsibility for overseeing a team of Medical Monitors (either direct reports or contractors/CROs).
- Knowledge of GVPs, GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.
- Strategic thinker, driven toward teamwork, excellence and continuous improvement.
- Demonstrated ability as a medical safety expert in a complex matrix environment.
- Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
- Detail-oriented, with solid leadership, organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously.
- General familiarity with biostatistics and clinical data review; expert in navigating scientific literature, interpretation of data, display of data (e.g. JReview, SpotFire, etc.).
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
- Highly proficient in standard computer software and MM related applications (MS Office 365, CTMS, eTMF, Safety Database).
- Ability to travel, in some cases, internationally. Learning agility and ‘scalability’ to take on increasing responsibility as grows .
- Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity.
- Understanding the legal and compliance environment.
- Ability to have fun!