Associate Director, Global Clinical Operations

Oblenio Bio, Inc.; Lexington (MA); Hybrid; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

Oblenio Bio, a clinical-stage biotech focused on T-cell engagers, seeks an Associate Director, Global Clinical Operations to lead global trial execution from start-up to close-out. You will manage CROs, vendors, timelines, budgets, and risk plans while collaborating with cross-functional teams to ensure quality and regulatory compliance.

The role emphasizes hands-on, fast-paced execution in a lean environment, with on-site work in Lexington, MA 2–3 days per week and opportunities for remote

Qualifikationen

• 8+ years in clinical operations with global trials.
• Experience managing CROs, vendors, budgets, and timelines.
• Strong knowledge of ICH-GCP and regulatory requirements including GDPR.
• Experience in early-stage development, immunology or biotech is a plus.

Aufgaben

• Serve as global Clinical Operations lead for assigned trials and workstreams.
• Develop and track study plans, timelines, budgets, enrollment forecasts, risk registers, and KPIs.
• Oversee CROs and clinical vendors, including contracting and performance metrics.
• Coordinate site identification, feasibility, activation, enrollment, monitoring, and closeout.
• Partner with Clinical Development, Regulatory, Data Management, CMC, Quality, and Translational Sciences.
• Contribute input to protocol development and study design with operational considerations.
• Ensure activities comply with ICH-GCP, GDPR, and company procedures; support inspection readiness.
• Lead or facilitate study team and vendor meetings, provide status reporting and risk escalation.

Kenntnisse

CRO management

Vendor oversight

Study timelines

Risk management

Global operations

Ausbildung

Bachelor's degree in science/healthcare

Advanced degree preferred

Jobbeschreibung

Available Position: Associate Director, Global Clinical Operations

Job Title: Associate Director, Global Clinical Operations

Reports To: Sr. Director, Global Clinical Operations

Company Overview: Oblenio Bio is a clinical-stage company focused on achieving the significant potential of T-cell engagers as a novel therapeutic approach that addresses underlying disease pathobiology and achieves immune reset. Oblenio Bio was formed in November 2024 by venture firm Aditum Bio following the exclusive option to license LBL-051, a T-cell engager antibody that targets BCMA, CD19, and CD3 to deplete pathogenic B cells with the aim to provide relief for the numerous patients living with refractory autoimmune disorders. In June, we announced a $62 million Series B financing and a publication of our non-human primate data. In early August, we announced that the first patients have been dosed in our first-in-human clinical study in autoimmune disease patients.

Oblenio is a lean, nimble company led by experienced biotech. Our development plan and clinical construct are differentiated, with an exciting opportunity to create substantial value for all of our stakeholders in the coming 12–18 months.

Position Summary:

Reporting to the Sr. Director, Clinical Operations, this role will serve as the global operational lead for assigned clinical trials and workstreams. The Associate Director is accountable for translating that direction into high-quality study execution. Working in a highly collaborative, science-driven, and agile biotech environment, this individual will partner closely with cross-functional colleagues and external partners across the full study lifecycle, with particular focus on CRO and vendor oversight, site execution, quality, timelines, and proactive risk management. The ideal candidate is energized by hands-on execution and problem-solving, can independently drive assigned studies and workstreams, and exercises sound judgment about when to resolve issues directly versus escalation of recommendations or decisions to senior leadership.

Position Responsibilities:

Serve as the global Clinical Operations lead for the assigned clinical trial(s) and workstreams under the direction of the Sr. Director, Clinical Operations, managing day-to-day execution from study start‑up through close‑out against agreed timelines, budgets, quality standards, and program objectives.

Develop, maintain, and track study plans, timelines, budgets, enrollment forecasts, risk registers, and key performance indicators for assigned studies; identify operational issues early, implement mitigation plans within delegated scope, and escalated material risks, trade-offs, or decisions to the Sr. Director as appropriate.

Oversee CROs and other clinical vendors for assigned studies, including participation in vendor selection and contracting and ongoing review of scopes of work, budgets, change orders, deliverables, timelines, and performance metrics; follow up on issues to support timely resolution.

Coordinate site identification, feasibility, activation, enrollment, monitoring, and closeout activities, working closely with CROs and sites to identify operational barriers, support enrollment, and maintain effective study execution.

Partner with internal stakeholders including Clinical Development, Regulatory, Data Management, CMC, Quality, and Translational Sciences to coordinate study activities, dependencies, and deliverables for assigned trials and workstreams, and provide operational recommendations to support broader program planning.

Contribute clinical operations input to protocol development and study design, including feasibility, patient and site burden, country and site strategy, enrollment assumptions, operational risk, and study implementation considerations.

Ensure assigned clinical trial activities are conducted in accordance with protocols, ICH‑GCP, applicable regulations, company procedures, and quality expectations; partner with Quality and other functions to support inspection readiness and timely resolution of compliance issues.

Lead or facilitate study team and vendor meetings for assigned studies, maintain clear decision and action tracking, provide concise study status reporting, and escalating issues, risks, resource needs, and recommendations to the Sr. Director, Clinical Operations, when broader functional or program‑level decisions are required.

Qualifications:

Bachelor's degree in a scientific, healthcare, or related discipline; advanced degree preferred.

Approximately 8+ years of progressive clinical operations experience in biotechnology, pharmaceutical, or related drug‑development organizations, including meaningful experience leading global or multi‑center clinical trials.

Demonstrated experience managing CROs, clinical vendors, study budgets, timelines, and site performance with a high degree of ownership and accountability.

Strong knowledge of clinical trial operations, ICH‑GCP, and applicable regulatory requirements including GDPR, with a track record of maintaining quality and inspection readiness.

Experience with early‑stage clinical development and complex or specialty indications preferred; experience in immunology, autoimmune disease, biologics, or T‑cell engager programs is a plus.

Ability to think quickly and operate both strategically and tactically in a lean, fast‑paced, evolving organization.

Ability to travel as required to investigator meetings, clinical sites, vendor meetings, and other study‑related activities.

Preference will be given to candidates based in the Greater Boston area who can work on‑site in Lexington, MA, approximately 2-3 days per week. Highly qualified remote candidates may also be considered.