Clinical Operations Leader

MOMA Therapeutics is looking for a Clinical Operations Leader

 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 be part of a group comprised of incredible humans who are committed to the discovery of transformative medicines for cancer patients
• Are needed… because patients are counting on you

About MOMA Therapeutics

At MOMA Therapeutics, we are motivated by a single common goal, to discover and develop innovative new medicines for patients through our singular focus: the therapeutic targeting of molecular machines.

In this role you will… 

Be responsible for the leadership, strategic planning, oversight and execution of clinical trials and projects for novel Oncology first in human studies. This role will be accountable for CRO selection, clinical trial management system selection/ implementation, data capture technologies, clinical trial master file, site monitoring, study start-up capabilities, and CRO management. The ideal candidate will be action-oriented, collaborative, and driven to establish infrastructure to support trials beginning in 2023 in a compliant manner. This individual will work closely with the management team to plan and execute the strategic direction of the function and be accountable for the execution of that strategy in partnership with our internal team and external partners. Using outstanding cross-functional skills to achieve program goals, this individual will develop a deep understanding of the clinical indications being pursued including knowledge of the patient needs, development precedent, regulatory guidance, and the competitive landscape in the therapeutic space.

Job Responsibilities:

• Have overall responsibility for the selection and management of clinical study sites and external vendors, including but not limited to CROs, specialized labs, vendors and others that support clinical programs
• Provide expertise for all aspects of clinical operations, including clinical site enrollment strategy, vendor oversight, budget management, protocol development, and providing strategic and tactical guidance in the planning, execution, and reporting of all operational aspects of the clinical trials
• Build a powerful capability for planning and modeling clinical trial timelines, enrollment assumptions, costs and generating feasibility data; establish best practices for defining, tracking, and responding in real-time to clinical trial metrics for optimized operational performance and efficiency
• Establishment of Data Review Committee and management of data cuts, integrity, and reporting
• Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with GCP and ICH guidelines
• Participate in regulatory document preparation including report writing and review
• Help to author clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary
• Oversee maintenance of trial documentation and master file, data validation and completion guidelines
• Lead responses to audits (site, internal file and process, and regulatory agencies)

About you…

• Bachelor’s or advanced degree and 10+ years or relevant and progressive clinical operations experience working in the pharmaceutical and/or biotech industry, preferably a mix of both
• Experience managing early-phase clinical studies in Oncology
• Solid well-grounded experience in setup, execution, and operational management of clinical trials (delivered on time, within budget, and with high quality)
• Proven track record of experience working with CROs, functional service providers and third-party vendors; strong contract negotiation abilities and thorough understanding of all financial aspects of contracts
• Strong and current knowledge in Good Clinical Practices and ICH Guidelines and the application to the conduct of clinical trials
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members
• Excellent planning, organization, and time management skills
• Effective communication and interpersonal skills
• Flexibility to travel as required
• You work hard, you are kind to others, and you enjoy being a part of a kick-ass collaborative team that gets stuff done
• You enjoy being in an environment where scientific data rules the day

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