Medical Monitor / Director

Description:

• Under appropriate supervision, manages the design, implementation, and evaluation of clinical study protocols in support of the clinical development program and aligned with the overall Product Development Plan, applying sound medical and scientific judgment, knowledge of compliance and regulatory requirements, and awareness of customers, markets, business operations, and emerging issues.
• Provides oversight of clinical studies, including monitoring overall study integrity and reviewing, interpreting, and communicating accumulating safety and efficacy data for the study.
• In collaboration with Clinical Operations, oversees study enrollment, timelines, and key deliverables, and is responsible for assessing and reporting serious adverse events in accordance with corporate policy and applicable regulations for assigned protocols.
• Oversees project-related education, training and guidance for investigators, study site personnel, study staff, and clinic staff, as appropriate.
• Maintains current expertise in the therapeutic area through medical literature and other learning opportunities, as well as through familiarity with relevant technologies and professional developments.
• Ensures compliance with Good Clinical Practice, pharmacovigilance standards, SOPs, and all other applicable quality and safety standards in the conduct of research and patient care.
• Demonstrates the highest standards of medical ethics at all times and seeks appropriate consultation when patient care issues or protocol-related questions are outside the scope of practice or expertise.
• Collaborates effectively with cross-functional partners across Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, Safety, Quality Assurance, and other matrix teams.
• Communicates scientific, clinical, and operational findings clearly and effectively to internal and external stakeholders.
• Participates in quality assurance and continuous quality improvement activities, including clinical audits, peer review, and regularly scheduled review meetings, as applicable.
• Advises/updates the Executive Director of clinical and operational matters.
• Contributes to training and knowledge sharing within the Clinical Development team, including procedures, clinical monitoring practices, data quality, actionable data interpretation, and workflow integration, as appropriate.
• Attends staff, committee, board, or other meetings as required to represent the department, clinic, or organization.

Qualifications:

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-U.S. equivalent degree, with relevant therapeutic specialty experience in an academic or hospital setting. U.S. residency training is strongly preferred; completion of a subspecialty fellowship is desirable. 5+ years of experience
• Acute Leukemia clinical experience and/or experience with AML trials is preferred.
• Medical monitoring experience, preferably with immunotherapies and ADCs, is highly desirable.
• Proven ability to collaborate in a cross-functional environment.
• Clinical trial experience in the pharmaceutical industry, academia, or an equivalent setting is preferred.
• Knowledge of clinical trial methodology, including medical monitoring, study oversight, and regulatory and compliance requirements governing clinical trials, is desirable.
• Ability to work effectively with global sites across multiple time zones.
• Demonstrated ability to independently interpret emerging safety and efficacy data, proactively identify risks, ensure accurate data entry, and appropriately escalate issues.
• Ability to interact effectively with both internal and external stakeholders to support global scientific and business strategy.
• Excellent oral and written communication skills in English.
• Strong organizational skills and attention to detail.
• Demonstrated ability to manage multiple priorities in a fast-paced, matrixed environment.
• Familiarity with Good Clinical Practice, pharmacovigilance principles, and clinical research compliance requirements.
• Hematology medical monitoring experience is preferred.
• MD with specialization in hematology,
• Independent medical monitor
• Previous clinical trial experience in AML
• Ability to thoroughly review safety data
• Collaborative with cross functions

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.