MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
**Relocation assistance available**
This position provides project management expertise and leads a cross-functional team through all aspects of design, planning, startup, conduct, analysis, reporting and closeout of assigned clinical trials. Responsibilities including managing timelines, budgets, clinical sites, vendors and deliverables while maintaining quality and regulatory compliance.
Responsibilities and Job Duties:
- Project Management – Responsible for overall execution of clinical trials within designated study budgets, timelines and quality standards.
- Clinical Trial Planning - Provides overall operational and strategic input prior to commencement of clinical trials that include, but are not limited to: clinical planning tools, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, Investigator selection, systems (e.g., CTMS, IXRS etc.), clinical trial related operational manuals, training materials, and various clinical trial plans (e.g., monitoring, risk mitigation, communication etc. plans) site selection and budget planning. Directs Clinical Operations team members on daily tasks and activities.
- Monitoring Activities - Oversee and directs other team members on clinical monitoring and site activities to ensure compliance with Good Clinical Practices (GCP) and applicable regulations. Oversee clinical monitoring (site qualification, site initiation, interim monitoring, clinical trial closeout visits) to ensure integrity, accuracy and accountability of clinical data. Informs Clinical Operations Director and other leadership (as appropriate) on overall clinical trial status and of potential issues/mitigation. May participate on site visits as needed or accompany junior team members for training purposes.
- Site Management – Develops communication pathways and study specific processes to allow team members to communicate with clinical trial sites regarding all logistics including contract agreements, support materials and training and IRB/EC application process, including review of informed consent / HIPAA forms for conformance to pertinent government regulations. Oversees set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance. Develops study training for study team, investigational sites, and vendors. Develops and oversees clinical site budgets, investigator payment processes and invoices related to projects assigned.
- Vendor Oversight – Key decision maker in the selection of clinical service provider personnel including contractors, and clinical research organizations, and with specification development, and management/oversight of third party personnel. Serves as the primary project contact for communication and coordination for the third-party vendors. Oversees the monitoring trip reports process and ensures resolution of all action items related to CROs. Ensures that vendors comply with all required standards and raises any issues and/or concerns. Oversee contract and budget preparation, negotiations and management throughout the trial life cycle
- Internal/External Meetings – Facilitates Clinical Study Team meetings that comprise of cross functional representation. Ensures that study information is disseminated to the appropriate parties. Oversees and manages other meetings to include: internal team meetings, investigator meetings, and other trial- specific meetings as required.
- Data Listing Review – Oversees in-house review of clinical data listings (protocol deviations, focused study data review, etc.) for completeness and accuracy and escalate issues as needed. Implements corrective actions to avoid or mitigate problems while considering the appropriate trade-offs of balancing risks with study deliverables and costs.
- Trial Master File - Ensures that the study regulatory files are collected and inventoried and filed as per MacroGenics requirements.
- Ancillary Supplies – Ensures study materials and supplies are appropriately managed in regards to ordering, tracking and within budgetary considerations.
- Study Management Tools – Ensures that study teams and clinical sites have the appropriate study management tools to execute the study.
- Clinical Operations Responsibilities – Act as a key contributor to the Clinical Operations department to include: clinical operations initiatives to streamline and improve processes, SOP development, Clinical Project Managers Forum, mentoring and developing Clinical Research Associates
Bachelor’s degree in a relevant scientific discipline
Experience - CPM Level
Minimum of seven years of relevant clinical trialexperience in the pharmaceutical or biotech industry with at least two of those years managing clinical trial activities. Oncology experience strongly preferred.
Experience - Sr. CPM Level
Minimum of nine years of relevant clinical trialexperience in the pharmaceutical or biotech industry with at least four of those years managing clinical trial activities. Oncology experience strongly preferred.
Knowledge, Skills and Abilities
- Thorough and integrated knowledge of the clinical trial process including cross-functional handoffs and dependencies
- Advanced skills and through knowledge in regard to all clinical operations and site management activities
- Advanced skills in Project Management, particularly in regard to management of schedule, budget, communication, resources and quality
- Ability to influence without authority
- Strong communication, and negotiation skills
- Strong leadership skills including the ability to create a sense of clear direction
- Experience in global trials
- Ability to travel to meetings, sites and vendors approximately 10-20%