Manager, Clinical Operations

MOMA Therapeutics is looking for an experienced Manger, Clinical Operations

Imagine joining a company where you….

• Will be part of an experienced and resilient team that is collectively unstoppable, trusts one another, and selflessly collaborates
• Will work with incredible humans who are committed to the discovery of transformative medicines for patients
• Are needed… because patients are counting on you

About MOMA Therapeutics

MOMA Therapeutics is seeking a talented Clinical Operations Manager to join our growing organization as we head into the clinic with our first asset. MOMA is a biotechnology company focused on developing inhibitors of highly dynamic proteins, namely ATPases, which play critical roles in a variety of Oncology indications. Our platform allows us to successfully prosecute drug discovery against difficult and unprecedented targets which are core cancer dependencies. MOMA is planning to initiate two clinical development programs in 2024. 

Summary of Responsibilities

Reporting into the head of Clinical Operations, the ideal Clinical Operations Manager will be responsible for supporting all clinical trial activities including vendor oversight and management, from study start-up through maintenance and close out of all clinical trials. These activities include but are not limited to preparation of study related materials, relationship management between study sites and vendors, support and oversight of study related activities, and identification of project risks and contingency planning. Additionally, this role will support building out the Clinical Operations organizational infrastructure to ensure operational excellence.

In this role you will…

• Support the clinical study team with the oversight of CROs and management of study-related activities including planning, execution, and close-out of clinical trials.
• Provide input and support in the planning and execution of early phase clinical trials including the oversight and directional alignment of timelines, budget, and key deliverables, as well as contributing to overall clinical strategy.
• Assist with the management of Clinical Operations vendors (eg, clinical CROs, central lab) as governed by MOMA’s clinical vendor oversight procedures.
• Provide input into and oversee development of clinical documents (eg, clinical study protocols, informed consent forms, investigator’s brochures, study reports) and project plans.
• Support with the management of study enrollment including (but not limited to) developing and tracking enrollment projections and goals, identifying and resolving recruitment risks, and implementing strategies to support enrollment objectives.
• Oversee the set up and maintenance of the internal electronic filing systems (eTMF) and general study filing, including periodic quality reviews, to ensure inspection readiness.
• Manage the tracking of research laboratory sampling to ensure complete traceability of clinical laboratory sampling.
• Support with study drug management activities including supply forecasting, shipment of material to clinical sites, and management of product complaints, in partnership with clinical supply chain.
• Manage the review and approval of clinical monitoring visit reports (MVR), including management of the MVR oversight tracker.
• Participate in case report form design, user acceptance testing, and periodic data review, in partnership with data management.
• Ensure meeting agendas are clear and distributed in advance; take comprehensive and precise minutes for internal and external meetings.
• Ensure all clinical trials are conducted according to relevant ICH/GCP guidelines and applicable local regulations.
• Identify potential risks and works with Clinical Operations leadership to assist in proactively resolving issues with vendors and study sites.
• Effectively communicate and interact with Key Opinion Leaders, study Investigators, and site staff.
• Support the Clinical Operations and Quality functions during audits, as needed.
• Set operational performance goals, key performance indicators, and targets.

About you…

Required Qualifications

• 4+ years of clinical research experience in a pharmaceutical or biotech setting with experience working in early oncology drug development (Phase 1) multi-national clinical studies.
• Knowledge of global clinical trial management in a CRO outsourced environment with the ability to assemble a plan and execute on the details.
• Exceptional organizational skills and ability to deal with competing priorities, as well as strong reasoning and problem-solving abilities.
• Excellent leadership skills and ability to lead, direct and support cross-functional teams.
• Strong knowledge of GCP/ICH and EU/EMA Guidelines for conducting clinical trials.
• Strong people and project management skills.
• Bachelor’s degree.

Preferred Qualifications

• Regulatory submission experience and/or exposure (eg, IND, NDA, ex-US CTAs, MAA).
• Health authority inspection experience.
• Experience in late-stage drug development (Phase 2+).

MOMA Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.