Back to jobs
New

Director, Clinical Operations, Oblenio Bio

Cambridge, MA

Company Overview

Oblenio Bio is focused on achieving the significant potential of T-cell engagers as a novel therapeutic approach that addresses underlying disease pathophysiology and achieves immune reset. An Aditum Bio company, Oblenio Bio was formed in November 2024 following the exclusive option to license LBL-051, a first-in-class T-cell engager antibody that targets both CD19 and BCMA in autoimmune disorders.   

Oblenio Bio is a portfolio company of Aditum Bio.

About Aditum Bio: Aditum Bio’s mission is to provide access to medicines to patients in need.  Co-founded by industry veterans Joe Jimenez, former CEO of Novartis and Mark Fishman, former President of the Novartis Institutes for Biomedical Research, the firm in-licenses promising therapies and advances them into Phase 1 and Phase 2 clinical studies to enable proof of concept.   The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual market launch, to reach patients in need.

In keeping with the Aditum Bio team culture, this position will be hybrid, with two days per week in person in Cambridge, MA.  Potential flexibility on this arrangement.

Position Summary

The Director of Clinical Operations will contribute to the execution of clinical development plans and contribute to the development of clinical trial strategy, leading the operational aspects of clinical trials from start to finish, including vendor selection and oversight. The Director of Clinical Operations will leverage a deep understanding of clinical trial operations, regulatory requirements, and industry best practices to ensure high quality study execution and within the established timelines and budgets.

Position Responsibilities

  • Conduct new clinical trial planning activities including operations strategy, budget and milestone development, vendor identification.
  • Contribute to CRO and site engagement, evaluation, and contracting processes.
  • Lead internal project plan and other study specific plans development, including but not limited to timeline, risk log, and vendor oversight.
  • Manage cross-functional study inputs, review and approval activities.
  • Lead the interactions and management of CRO and other vendors from startup to the end of the contracted engagement, with accurate tracking and reporting of study progress and metrics.
  • Ensure quality, compliance, and timeliness of all deliverables.
  • Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports
  • Contribute to SOPs, standards, and technology development.

 Qualifications

  • BS or BA Degree required, in a science or health related field. Advance degree preferred.
  • Minimum 10 years experience biotech/pharma/CRO clinical trials experience with at least 6 years hands-on end-to-end international clinical project management experience.
  • Experience in Immunology/I&I and experience with mAb therapeutics preferred.
  • Experience in early phase clinical trials including Phase I and II studies preferred.
  • Experience with outsourced model preferred.
  • Experience with clinical operations applications, eCOA and DCT preferred.
  • Demonstrated core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan. Excellent understanding and working knowledge of clinical research, phases of clinical studies, current ICH GCP & country clinical research law & guidelines.
  • Proficient understanding of R&D processes including the principals of study design and execution; knowledge of industry standards and practices.
  • Strong organizational skills and demonstrated ability to develop positive working relationships with internal and external organizations and stakeholders.
  • Results-oriented, motivated, and flexible.

The range for this full-time position is $225,000 - $245,000, plus a target bonus, equity compensation and benefits including medical, dental, vision, and 401k. Our salary ranges are determined by role, level and location. The range displayed on our postings reflects the minimum and maximum for new hire salaries. Within the range, individual pay is determined by interview performance, job-related skills, experience and relevant education and training. Please note the range reflects base salary and does not include target bonus, equity or benefits.

 

 

We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

 

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Aditum Bio’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.