Clinical Operations Consultant Oncology
Clinical Operations Consultant Oncology
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Job Description
About MOMA Therapeutics
MOMA Therapeutics is a clinicalstage nextgeneration precision medicine company dedicated to targeting highly dynamic proteins that underlie human disease via a small molecule approach utilizing its proprietary KNOMATICTM platform.
The platform was designed to exploit key vulnerabilities inherent to all dynamic proteins namely their dependence on wellcoordinated stepwise changes in protein conformation. By focusing on genetically validated targets with high translation potential MOMA is rapidly advancing its pipeline toward responses in the clinic. MOMAs lead assets include:
- MOMA313 A selective polymerase helicase theta inhibitor in Phase 1
- MOMA989 A next generation selective PARP1 inhibitor currently in IND enabling studies
- MOMA341 A selective Werner helicase inhibitor in Phase 1
MOMAs preclinical pipeline consisting of whollyowned assets and discovery partnerships with Roche and Bayer. For more information go to.
The Role
We are seeking an experienced Clinical Operations Consultant to manage at least one oncology clinical trial under the leadership of the Senior Director Clinical Operations. This role will be responsible for overseeing the design and daytoday of the clinical trial ensuring timely completion and quality data collaborating with clinical trial centers and investigators management of trial timelines and budget and management of vendors and CROs. This role will have regular interaction with senior management and will be expected to communicate with and foster effective relationships with internal and external stakeholders.
Key responsibilities include (but are not limited to) the following:
- Oversee the setup and delivery of global clinical trial projects
- Work crossfunctionally to coordinate the relevant and timeline exchange of information and materials to support clinical trial deliverables
- Set study goals manage timelines and oversee vendor deliverables
- Manage study budgets and track progress from startup to closeout
- Assist in authoring of clinical trial protocols investigators brochures (IBs) informed consent forms (ICFs) clinical study reports (CSRs) and other clinical documents as necessary
- Lead protocol implementation with vendors and sites and ensure operational feasibility of the clinical trial
- Support the selection and management of investigators and clinical trial sites
- Collaborate and maintain strong relationships with CROs vendors and sites to ensure study deliverables are met and issues/risks are proactively identified and mitigated
- Support and manage oversight activities of all necessary vendors to ensure a high level of operational excellence is maintained
- Collaborate with CRO and sites to ensure the clinical study database is current accurate and routinely cleaned
- Support the clinical operations infrastructure build to maintain inspection readiness
- Line management responsibilities including hiring performance management career development and mentorship
- Communicate program and trial updates including risks and contingency plans with senior management and key stakeholders regularly
Key qualifications include the following:
- Bachelors degree in a scientific discipline.
- 8 years of clinical research experience with at least 5 years of industry experience (pharmaceutical or biotech)
- Minimum of 5 years of early (Phase 12 oncology drug development experience including experience supporting IND (CTA) submission activities. Experience in latestage drug development is a plus.
- Knowledge of global clinical trial management in fast paced CRO outsourced environment with the ability to assemble a plan and execute on the details
- Excellent leadership skills and ability to lead direct and support crossfunctional teams
- Ability to manage multiple priorities independently in a fastpaced environment
- Strong working knowledge of GCP/ICH and EU/EMA Guidelines for conducting clinical trials
- Anticipated travel up to 1020
- This is an onsite position 3 days per week) in the Boston area with considerable flexibility
- Local candidates only
This is a 1099 Independent Consulting position. As such the selected candidate will not be an employee of MOMA Therapeutics and this role is not benefitseligible. The consultant will be responsible for their own taxes insurance and any other statutory obligations.
What We Offer:
Our team members are empowered to deliver on their goals in a highly collaborative environment working alongside experienced drug developers to bring highly innovative medicines to patients in need. We offer a fastpaced sciencedriven patientfocused environment founded on 4 core values:
- Science with Purpose
- Courage to Act
- Succeeding Together
- Joy in our Work and Each other
MOMAtes (full time employees) receive a highly competitive benefits package including health dental and vision coverage as well as unlimited PTO a weeklong company wide shut down comprehensive insurances student loan repayment support and family support including family forming benefits. We encourage all MOMAtes to work onsite 3 days per week in an attractive lab and office environment and provide commuting benefits as well as subsidized lunches each day and a range of snacks and beverages available at all times.
Interested in learning more about how MOMA differentiates itself in the workplace Visit the MOMA Team section of our website. Experience:
Contract
Employment Type
Full Time
Key Skills
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