Senior Director / Executive Director, Clinical Operations

GENERAL SCOPE AND SUMMARY

Sensorium Therapeutics is searching for a high achieving career professional with an entrepreneurial spirit to lead the operational execution of our clinical studies across SENS-01, SENS-03, and SENS-08. Reporting to the Chief Medical Officer, the position is responsible for the operational planning, startup, and delivery of Sensorium’s clinical trial activities, partnering closely with CROs and specialty vendors to deliver trials on time, on budget, and to the highest quality standard.

This requisition is posted at two levels. The Senior Director level suits a candidate ready to own portfolio-level operational delivery with support; the Executive Director level suits a candidate who has already built a clinical operations function and carried accountability for global Phase 2 or Phase 3execution. Final level is set by experience at the time of offer.

The ideal candidate will embrace a collaborative and innovative culture towards continuous improvement, guided by the principle of patients first. They must thrive working in a fast-paced environment while remaining agile, proactive, and curious.

ROLES AND RESPONSIBILITIES

• Leads the operational planning, startup, and execution of Sensorium’s clinical trial activities across the portfolio, including the SENS-01 Phase 1b MAD study targeting first patient in early 2027, as well as Phase 2a through Phase 3 studies
• Oversees clinical program management and project management for the clinical organization
• Facilitates problem-solving and conflict resolution with internal and external stakeholders to reduce issues, remove roadblocks, and keep teams on track with key deliverables
• Owns study timelines, budgets, and resourcing, and drives cross-functional delivery against program milestones
• Presents clinical operations strategy and program status updates to study teams and in executive meetings
• Selects, contracts, and manages CROs and functional service providers, overseeing their day-to-day performance against scope, timelines, and quality expectations
• Manages specialty vendors directly — including qEEG, central and specialty labs, biomarker and bioanalytical providers, IRT and randomization, ePRO and eCOA, and clinical drug supply — rather than relying solely on CRO oversight
• Leads or assists in writing, reviewing, and approving clinical project deliverables such as scope definition documents, investigational product labeling, pharmacy manuals, informed consent, IRB/EC and health authority submissions and approvals, site activations, monitoring plans and tools, CRFs, data management plans, edit checks, safety plans, close-out plans, inspection readiness plans, and clinical study reports
• Leads site identification, feasibility, selection, activation, and ongoing site management and monitoring oversight
• Drives operational readiness for the SENS-01 Phase 1b MAD transition, translating the protocol into an executable operational plan ahead of the first-patient target
• Partners with Nonclinical, CMC, Regulatory, and Quality to support SENS-03’s path through IND-enabling studies and toward first-in-human readiness
• Provides early operational input for SENS-08 as it advances through lead optimization beginning mid-2027, informing the development plan for cognitive dysfunction associated with neurodegenerative disease
• Establishes and manages clinical trial budgets and forecasts, tracks spend, and oversees vendor and site contracting and payments
• Ensures trials are conducted in compliance with ICH-GCP, applicable regulations, SOPs, and study protocols, and supports inspection readiness in partnership with Quality Assurance
• Builds clinical operations infrastructure — SOPs, systems such as CTMS and eTMF, vendor governance, and processes — appropriate to a lean, growing organization
• Provides leadership and oversight for audits, inspections, quality events, and CAPAs across clinical programs, partnering with Quality to ensure inspection readiness, timely responses, and effective CAPA execution
• Drives continuous process improvement and quality risk management within Clinical Operations
• Operates hands-on through consultants and partners in the near term, then builds, hires, and leads an internal Clinical Operations team as the portfolio grows

QUALIFICATIONS

REQUIRED:

• Bachelor’s degree in a life sciences or related discipline required; an advanced degree is a plus
• Minimum of 8 years of clinical operations experience inthe biotechnology or pharmaceutical industry, with progressively senior leadership responsibility; additional experience expected at the Executive Director level
• Demonstrated experience leading the operational delivery of Phase 1 through Phase 3 clinical trials from startup through close-out
• Hands-on experience selecting and managing both CROs and specialty vendors directly, for example qEEG, central and specialty labs, biomarker labs, IRT, and ePRO or eCOA
• Thorough understanding of and experience in the execution of global clinical trials, managing Phase 1 through 3 from initiation to BLA/NDA approval, across a diverse range of patient populations and therapeutic areas
• Experience managing study budgets, timelines, and cross-functional teams in a fast-paced environment
• Extensive knowledge of clinical research, including FDA and international regulations, ICH-GCP, clinical trial design and documentation, and the conduct of clinical trials
• Knowledge and experience of building clinical operations infrastructure aligned with the needs of an early-stage growing organization
• CNS, neuroscience, or neurodegenerative disease trial experience preferred
• Experience building clinical operations functions, processes, or teams within an emerging biotech preferred

If you’re a flexible powerhouse and are curious about science, this is an excellent opportunity to join a company that’s growing fast and making a difference.  You must be: 

• Highly organized, with excellent judgment as well as strong project management and problem-solving skills.
• Able to step into an unstructured world and provide that structure effectively.
• A hands-on operational leader who can set strategy and personally drive execution, vendors, and timelines.
• Able to see the big picture clearly and understand the long-term goals of the business.
• Friendly and professional in demeanor, with exceptional interpersonal skills and a great sense of humor.
• Excited about change as an invitation to stretch and grow.
• Able to communicate effectively with internal and external stakeholders at all levels.
• Able to thrive in a dynamic work environment where policies and procedures are still taking shape.
• Someone who enjoys opportunities to pitch in and help when necessary, even if it means shuffling your own priorities on the fly (again) and stepping outside your job description.
  

COMPENSATION AND BENEFITS

Base salary range: Actual base salary will be determined by level, role-relevant experience, demonstrated capability, and internal equity, and may fall anywhere within the range.

In addition to a competitive base salary, this position includes:

• Performance bonus and equity
• Medical, dental, and vision coverage for employees and dependents
• 401(k)
• Company-paid life and disability insurance
• Unlimited paid time off, company holidays, and paid parental leave
• Support for scientific conferences and professional development

WORK LOCATION

This position is remote and open to candidates anywhere in the United States. Sensorium is headquartered in Boston, and the role carries a regular onsite cadence: travel to Boston for company meetings, plus investigator meetings, site visits, vendor governance meetings, and scientific congresses. Candidates who prefer a Boston-area hybrid arrangement are equally welcome.

HOW TO APPLY

Qualified candidates are encouraged to submit their resumes to careers@sensorium.bio. Applications will be reviewed on a rolling basis and accepted until the position is filled. Candidates unsure whether their background fits are encouraged to reach out. We are also open to discussing interim or consulting arrangements for candidates available immediately.

EQUAL EMPLOYMENT OPPORTUNITY

Sensorium Therapeutics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, ancestry, age, genetic information, physical or mental disability, protected veteran status, military service, marital status, or any other characteristic protected by federal, state, or local law.

Sensorium provides reasonable accommodations for applicants with disabilities and for those who need accommodation for religious reasons. If you need an accommodation at any stage of the application or interview process, please contact careers@sensorium.bio.

This job description is not intended to be an exhaustive list of all duties, responsibilities, or aspects of the position. Duties may be added, and this description may be amended, at any time at the sole discretion of Sensorium Therapeutics.