Noema Pharma is a clinical-stage biotech company targeting debilitating central nervous system (CNS) disorders characterized by imbalanced neuronal networks.
At Noema Pharma, every patient matters.
Our pipeline contains novel therapies designed to address debilitating CNS disorders in order to improve quality of life and patient outcomes.
We partner with patients, their families and caregivers, and healthcare professionals to provide a comprehensive approach that goes beyond treating symptoms to ensure that patients’ experiences, perspectives, needs, and priorities are meaningfully incorporated into our work.
You will be a member of a cross-functional Clinical Trial Team, driving cross-functional interfaces and providing direction and guidance to the team for successful trial execution.
Tasks
- Lead the planning, execution, and management of global clinical trials in neuroscience from initiation to completion.
- Collaborate with cross-functional teams, including clinical operations, clinical development, regulatory affairs, and data management, to ensure the successful implementation of clinical trial protocols.
- Develop and oversee clinical trial budgets, timelines, and resource allocations, ensuring adherence to quality standards and regulatory requirements.
- Interface with key stakeholders, including CROs, investigators, key opinion leaders, and study sites, fostering strong relationships and effective communication.
- Monitor trial progress, review data quality, identify and address potential issues, and implement corrective actions as necessary.
- Stay current with industry trends, regulatory guidelines, and scientific advancements in oncology, incorporating relevant knowledge into trial strategies.
- Contribute to the development of clinical development plans and study protocols. Ensures clinical trial is inspection-ready at all time and Trial Master File (TMF) completion including TMF plan is in place and ongoing QC activities are performed to always ensure TMF completeness.
- Contributes to process improvements or acts as Subject Matter Expert for SOP development / update or training.
- Coaches new clinical trial colleagues during their onboarding as assigned.
Requirements
- Advanced degree in a relevant scientific discipline (PhD MS, MPH or equivalent).
- At least 7 years of experience in clinical trial management in neuroscience including project management
- Proven track record of successfully leading global clinical trials from inception to completion, mainly in Phase II & Phase III.
- In-depth knowledge of GCP, ICH guidelines, EU CTR, US FDA CFR, and other relevant regulatory requirements.
- Experience with health authority inspections (FDA / EMA) and audits preferred.
- Strong leadership and communication skills, with the ability to collaborate effectively across diverse teams and cultures.
- Exceptional organizational and problem-solving abilities.
Proficiency in project management tools and systems.
Demonstrated ability to effectively forecast and manage trial budget.
If you live in the Boston / New York area and if your profile matches the above description, we look forward to your application.
Noema Pharma is a biotech company developing groundbreaking therapies to address the most disabling symptoms in orphan conditions of the brain and nervous system.
Noema’s research and development is focused on understanding and meeting patient needs using our novel therapies.
Senior Manager/Associate Director of Regulatory Strategy
As the Senior Manager/Associate Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. You will collaborate closely with cross-functional teams, including Clinical Development, Medica...
Associate Director, Clinical Operations
Lead the development of contingency/risk management plans for projects and assist Director/Senior Director of Clinical Operations in the preparation and execution of sound development strategies. Provide strategic input and execution of clinical trials from protocol design to the final clinical stud...
Senior Submission Manager, Regulatory Operations
The Sr Mgr will also support the Director of Regulatory Operations, or other members of the Regulatory Affairs, in activities related to setting standards, best practices, metrics collection, developing new procedures and work instructions, and lessons learned dissemination, and will assist in other...
Associate Director, Global Discovery Operations Lead
The Associate Director, Operations Lead is a central and critical role in Global R&D Discovery IT that is responsible for providing excellent user experience which relies on stable, consistent, and compliant operations and support. Associate Director,Global Discovery Operations Lead. In this role, t...
Project Manager - Operations and Standards
This position will report to the Senior Manager of Project Management Governance and Training. For the assigned portfolio(s), follow the project readiness and startup procedure and fulfill the role of Operations business partner, contacting CALs, reviewing project manager capacity, experience and tr...
Senior Clinical Scientist, Hematology, Neuroimmunology, and Specialty Care Senior Director
The Senior Clinical Scientist, Hematology, Neuroimmunology and Specialty Care (HNSC) will support the HNSC Team in all activities related to development of HNSC assets. Applies clinical/medical decision making to clinical development issues. Develop independently or in collaboration with different f...
Clinical Development Senior Medical Director, Hematology
The Senior Medical Director will provide clinical development leadership for cross-functional teams to support early phase clinical development activities, facilitate achievement of clinical development goals in a matrixed team environment, and shape the clinical development strategy for hemoglobino...
Senior Investment Director - Private Investment Specialist
Research private investment asset classes, products and investment managers in coordination with our team and our global manager research colleagues including: perform due diligence on managers, lead, and deliver private investment research projects. Cambridge Associates (CA) is a leading global inv...
Clinical Trial Manager
The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. A minimum 5+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role. Accountable for project related efforts for the delivery of studies ...
ATC Strategy and Operations Associate Director, US Heme
ATC Strategy & Operations Associate Director, US Heme. The Authorized Treatment Center (ATC) Strategy & Operations Associate Director, US Heme. Collaborates closely with the Heme Program Manager to ensure all ATC activation deliverables are captured and kept. ...