Clinical Operations Manager
MaaT Pharma is an Oncology Microbiome clinical stage company developing biotherapeutics to treat high unmet medical needs. We are among the most advanced Microbiome companies with two programs in clinical development.
We have a humanistic approach to our entrepreneurial adventure. Each recruitment is an opportunity for us to construct a rich and diverse company ecosystem where our 40 people can thrive and influence. We are searching for passionate teammates eager to be part of our adventure.
We are seeking an engaged and proactive clinical operations manager to focus on developing MaaT Pharma’s microbiome restoration therapies in phases I-III studies and to play an increasingly leading role in our clinical development team, reporting directly to the CMO.
The clinical operations manager will manage operational activities for MaaT Pharma’s clinical studies in hematology and oncology, from study start-up through completion.
He/She will develop and maintain relationships with both external and internal stakeholders, supervising and coordinating the activity of Clinical Research Organizations (CROs) and their teams, and of study sites, their study coordinators and local teams, in all aspects related to the smooth running of clinical operations at MaaT Pharma.
The clinical operations manager will be a key contributor to clinical development plans and will manage all operational aspects for existing and new clinical studies of Maat Microbiome Restoration Biotherapeutics (MMRBs), in close coordination with the regulatory, project management, preclinical and clinical teams. This position is preferably based in Lyon.
Description of key responsibilities
- Ensure that the clinical trial(s) of MaaT Pharma run smoothly and according to budget and plan.
- Under the supervision of the CMO, collect, synthesize and report study information for the creation, review and maintenance of study trackers; incl. the presentation of the trackers during team meetings.
- Collaborate with the Clinical Supplies Platform to validate IMP needs, specifications, packaging, shipment (including resupply) and reconciliation processes.
- Help ensure proper and timely IMP availability at all study centers. Provide usage visibility to the Pharmaceutical Development Department.
- Involvement in the preparation of study-related materials, like newsletters, doctor’s pocket-cards and forms to support inclusion.
- Ensure the availability and distribution of study-supporting material.
- Organize and lead study-specific meetings as needed, including the participation in regular meetings with vendors.
- Ensure consistent, efficient and effective communication with vendors and sites.
- Participate in selection of new vendors, and in the development / follow-up of associated budgets.
- Ensure that MaaT Pharma carefully selects and effectively manages its CROs.
- Preparation and oversight of study audits/inspections both internal and external. Provide oversight and preparation for regulatory authorities’ meetings and inspections.
- Ensure that the clinical operations department runs according to GCP.
Required skills and background
- BAC +8 years in pharmaceutical industry or clinical research organization, ideally in the area of oncology / hematology.
- Fluent English
- Fluent French
- + 8 years experience in the management of clinical operations, at either a pharma or biotech company or at a CRO. This should include the negotiating of study contracts, budget management, study tracking, documentation of follow-up activities and related administrative duties.
- Experience in managing multi-site, multi-country clinical studies, from an Operations perspective.
- Ability to be a team player and to take leadership roles in meetings and for projects.
- Ability to anticipate and escalate issues, to propose appropriate action plans, monitor KPIs, CAPAs, etc
- Ability to manage study tracker tools
- Ability to lead cross-functional projects with good project management skills and able to coordinate multiple interfaces, internally and externally
- Ability to foster team spirit and motivation across different departments
- Strong understanding of regulatory and safety aspects associated with Clinical trials, Clinical trial master files, and general clinical study documentation.
- Good working knowledge of GCP, ICH, and EMA regulations – of FDA regulations a plus.
- Strong document writing skills for all documentation related to competent authorities.
- External vendor management and business communication skills; leadership potential.
- Very good organizational skills including attention to detail and multi-tasking abilities.
- Ability to adapt to change, managing resources in an efficient, outcome-oriented manner.