Associate Director, Clinical Trial Management
Company: Modex Therapeutics Ltd.
Location: Weston
Posted on: February 27, 2026
|
|
|
Job Description:
Company Overview ModeX Therapeutics, an OPKO Health company, is
the leading clinical-stage biopharmaceutical company developing
unique and proprietary-multispecific therapeutics. Its MSTAR
platform unites the power of multiple biologics in a single
molecule to create multispecific antibodies that bind four or more
targets with unprecedented versatility and potency for complex
diseases. Its promising first-in-class immunology pipeline includes
candidates against immune diseases, including cancer (both solid
and hematologic tumors), immune impairment, as well as several of
the world's most pressing viral threats. Its founding team includes
globally recognized medical innovators with proven track records of
delivering breakthroughs for patients. ModeX is based in Weston,
Massachusetts. For more information, please visitâ?¯
www.modextx.com . Job Description Job Summary: The Associate
Director, Clinical Trial Manager is a valued position within the
ModeX clinical operations team. The primary role of this position
is to ensure all trial deliverables are met according to timelines,
budget, operational procedures, and quality standards (e.g., GCP,
ICH, and ModeX standards). This includes independent
responsibilities associated with planning, start-up, maintenance,
and closeout of clinical trials, as well as providing leadership
and mentorship to study team members. The Associate Director CTM is
expected to guide cross-functional collaborators, support the
development of junior staff, and foster a high-performing,
collaborative team environment. Key responsibilities include but
are not limited to: Oversee the successful implementation,
management, and closeout of ModeX clinical studies Understand and
track day-to-day budget and major budget milestones Support the
clinical protocol development process in collaboration with the
Head of Clinical Operations and the Medical Monitor Contribute in
the development of clinical protocols, amendments, and related
documents; drive and/or contribute to the development of
trial-related documents and processes Assist in the management of 3
rd party vendors with primary focus on the CRO Lead the development
of study tools, guidelines, and training materials to support
effective and accurate execution of clinical trial activities
Develop relationships with Investigators and Site Staff as primary
contact for clinical conduct of the trial Under the guidance of the
Head of Clinical Operations, manage study start-up activities
including regulatory documents, budget, and clinical trial
agreements. Participate in the ongoing review and cleaning of
clinical trial data. Chair study team meetings, collecting input
from all functional lines. Participate in site identification;
attending PSVs and SIVs Oversee tracking, logistics, and quality
operations for biological samples supporting clinical trials from
collection to analysis ensuring that sample inventories are
accurate, complete, and up-to-date through effective interactions
with internal teams, sites, central reference labs, specialty lab
partners, external collaborators (e.g. Academia) and third-party
vendors Oversee management of accurate enrollment log/trial
allocations forms Ensure compliance with patient consent for
collection and intended use, destruction, storage and/or future,
post-study use of biological samples Communicate with management to
ensure transparency throughout the course of the trial(s) regarding
study metrics and overall status Participate in process improvement
projects (as necessary) Qualifications: BA/BS degree required 7-10
years of relevant professional experience, with 5 years of clinical
operations experience in immunology, oncology or rare diseases.
Detailed and precise record keeping skills are essential as well as
the ability to track and resolve issues Excellent teamwork,
communication (verbal and written), organizational, and
interpersonal skills Self-motivated, proactive, and able to
prioritize and manage multiple projects simultaneously ModeX
Therapeutics is an Equal Opportunity Employer.
Keywords: Modex Therapeutics Ltd., Marthas Vineyard , Associate Director, Clinical Trial Management, Healthcare , Weston, Massachusetts