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Clinical Trial Managment, Director
3 months ago
IGI is an alliance between Ichnos Sciences Inc., a global fully-integrated clinical stage biotech company developing multispecifics™ in oncology, and its parent, Glenmark Pharmaceuticals Limited (Glenmark), with the aim to accelerate new drug discovery in cancer treatment.
Our vision:
Daring to imagine a world where cure is possible. Moving beyond hope, with therapies that will forever transform medicine and lives.
Our mission:
To co-create innovative treatment solutions that make healthier living possible.
Role Overview / Purpose:
Director of Clinical Trial Management is crucial in the field of clinical research. This position involves overseeing the planning, execution, and completion of clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory requirements. The role will be responsible for the overall management and oversight of the study, in compliance with the study protocol and international standards of Good Clinical Practice (GCP). They will work closely with the wider multifunctional team.
Overall Job Responsibilities
Strategic Planning
- Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with a focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
- Develop and implement clinical trial strategies and plans to support execution of the clinical development plan.
- Collaborate with senior management to align trial objectives with company goals.
Team Leadership
- Manage and mentor clinical trial managers and other team members.
- Ensure effective team performance and professional development.
Regulatory Compliance
- Ensure that trials are conducted in compliance with regulatory requirements (e.g., FDA, EMA).
- Collaborate with the preparation and submission of regulatory documents.
Budget and Resource Management
- Develop and manage trial budgets.
- Allocate resources effectively to meet trial objectives.
Vendor and Contract Management
- Support the selection, oversight, and management of CROs and other vendors
- Oversee the negotiation and execution of contracts.
Data and Reporting
- Monitor trial progress and ensure data integrity.
- Prepare and review trial reports and documentation.
Risk Management
- Identify potential risks and develop mitigation strategies.
- Address and resolve issues that arise during the trial.
Stakeholder Communication
- Communicate with stakeholders, including investigators, sponsors, and regulatory bodies.
- Ensure transparency and timely updates on trial progress
Key Relationships / Stakeholders
External:
- Experience interacting with varying levels of internal/external management, Investigators and site personnel, clinicians, scientists, and cross-functional teams.
Educational Qualifications
A degree in life sciences, medicine, or a related field. Advanced degrees or certifications are often preferred.
Experience
- At least 10 years + experience driving industry-sponsored clinical trials in clinical development roles.
- Deep understanding of the principles of clinical trial methodology, statistics, data analysis, and interpretation.
Knowledge and Skills (Functional / Technical)
- Deep understanding of regulatory requirements and guidelines.
- Extensive experience in clinical trial management, including experience in a leadership or director-level role.
Behavioral Attributes
- Strong ability to lead and motivate a team, manage conflicts, and drive project success.
- Excellent verbal and written communication skills for effective stakeholder interaction
This is an exempt role and is not eligible for overtime. The good faith base salary range for NY is $200K - $230K. This is a hybrid role; 3 days in the NYC office.
No relocation or immigration sponsorship is being offered at this time for this position. Candidate must be located within the tri-state area.
Ichnos Sciences, Inc. & Ichnos Glenmark Innovation are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, height, weight, protected veteran status, or any other characteristic protected by law.
** DIRECT HIRE ONLY. OUTSIDE RECRUITERS & RECRUITING AGENCIES ARE NOT BEING EMPLOYED BY ICHNOS SCIENCES TO FILL THIS POSITION. **
