Senior Director / Executive Director, Clinical Operations
for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must include sections only when posting has real specific content. We must not repeat job title as heading. Must not include Job ID etc. Must preserve all substantive info, remove boilerplate (cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions). Also remove "HOW TO APPLY", "EQUAL EMPLOYMENT OPPORTUNITY", etc.
We need to extract content: The posting includes:
- Reports to: Chief Medical Officer
- Function: Clinical Operations / Research & Development
- Level: Senior Director or Executive Director, set by experience at offer
- Location: Remote, United States — with regular travel to Boston for company meetings, as needed
- Employment type: Full-time, exempt
- Travel: Approximately 20–25%, domestic and occasional international
- Base salary range: Commensurate on experience, plus performance bonus and equity
- GENERAL SCOPE AND SUMMARY (paragraph)
- ROLES AND RESPONSIBILITIES (list of duties)
- QUALIFICATIONS (list of required qualifications)
- Then "If you’re a flexible powerhouse..." paragraph (maybe skills/attributes)
- COMPENSATION AND BENEFITS (list)
- WORK LOCATION (paragraph)
- Then HOW TO APPLY etc (remove)
- EQUAL EMPLOYMENT OPPORTUNITY (remove)
- etc.
We need to decide sections: About the role (maybe the GENERAL SCOPE AND SUMMARY). Responsibilities (ROLES AND RESPONSIBILITIES). Requirements (maybe QUALIFICATIONS). Skills (maybe the "If you’re a flexible powerhouse..." paragraph). Benefits (COMPENSATION AND BENEFITS). Pay (maybe base salary range? but they said only include Pay section if posting actually states them. It says "Base salary range: Commensurate on experience, plus performance bonus and equity". That's vague but it's stated. However they said never emit a heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD"). The phrase "Commensa te on experience" is similar to "commensurate with experience". That's placeholder-ish. Should we include Pay? The instruction: "never create Pay/Schedule/Benefits sections unless the posting actually states them." It does state base salary range: "Commensa te on experience, plus performance bonus and equity". That's still vague but it's stated. However they also say "never emit a heading followed by filler/placeholder text (e.g., 'commensurate with experience', 'not specified', 'N/A', 'varies', 'TBD')". So if we include Pay heading with that content, it would be filler. So better to omit Pay section. Instead we could include Benefits section (they have details). Schedule? Not given explicitly; travel percentage maybe schedule? Not exactly schedule. Could include Schedule? Not stated. So we omit Schedule.
Thus sections: About the role (h3), Responsibilities (h3), Requirements (h3), Skills (h3), Benefits (h3). Possibly also Work Location? Could be part of About the role or separate? Not in list of allowed headings; but we could incorporate into About the role or maybe a separate section like "Work Location" not in allowed headings list; they only listed those specific headings. So we should not create other headings. So we incorporate location info into About the role paragraph.
We must use - for any list of duties/requirements/benefits. Use
for prose.
We need to preserve all substantive information; do not invent or summarize away detail. So we need to keep all details from the posting, but we can format as lists.
Let's extract details:
About the role (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 3 execution. 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."
Also include location, reports to, function, level, employment type, travel. Could embed in About the role paragraph.
Responsibilities: list each bullet from ROLES AND RESPONSIBILITIES.
Let's extract each sentence as a list item:
- 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: list each bullet from QUALIFICATIONS section.
Extract:
- 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 in the 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
Skills: from "If you’re a flexible powerhouse..." paragraph.
Extract sentences:
- 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.
We could make each as list item under Skills.
Benefits: from COMPENSATION AND BENEFITS.
List:
- 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
Also base salary range? We decided not to include Pay section due to placeholder. But we could mention base salary range in About the role? Might be considered part of compensation but we already have Benefits. The instruction: "never create Pay/Schedule/Benefits sections unless the posting actually states them." Benefits section is okay because they state benefits. Pay section we avoid because it's vague. So we omit Pay.
We also need to include location, reports to, function, level, employment type, travel in About the role paragraph.
Let's craft About the role paragraph:
Reports to: Chief Medical Officer. Function: Clinical Operations / Research & Development. Level: Senior Director or Executive Director, set by experience at offer. Location: Remote, United States — with regular travel to Boston for company meetings, as needed. Employment type: Full-time, exempt. Travel: Approximately 20–25%, domestic and occasional international. 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
for prose. We need to preserve all substantive information; do not invent or summarize away detail. So we need to keep all details from the posting, but we can format as lists. Let's extract details: About the role (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 3 execution. 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." Also include location, reports to, function, level, employment type, travel. Could embed in About the role paragraph. Responsibilities: list each bullet from ROLES AND RESPONSIBILITIES. Let's extract each sentence as a list item: - 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: list each bullet from QUALIFICATIONS section. Extract: - 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 in the 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 Skills: from "If you’re a flexible powerhouse..." paragraph. Extract sentences: - 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. We could make each as list item under Skills. Benefits: from COMPENSATION AND BENEFITS. List: - 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 Also base salary range? We decided not to include Pay section due to placeholder. But we could mention base salary range in About the role? Might be considered part of compensation but we already have Benefits. The instruction: "never create Pay/Schedule/Benefits sections unless the posting actually states them." Benefits section is okay because they state benefits. Pay section we avoid because it's vague. So we omit Pay. We also need to include location, reports to, function, level, employment type, travel in About the role paragraph. Let's craft About the role paragraph:
Reports to: Chief Medical Officer. Function: Clinical Operations / Research & Development. Level: Senior Director or Executive Director, set by experience at offer. Location: Remote, United States — with regular travel to Boston for company meetings, as needed. Employment type: Full-time, exempt. Travel: Approximately 20–25%, domestic and occasional international. 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