Director, Clinical Operations

$220k - $235k

Taylor Strategy Partners

Description

DIRECTOR, CLINICAL OPERATIONS
JOB SUMMARY
The Director, Clinical Operations, is responsible for the strategic planning, oversight, and execution of assigned clinical trials, ensuring adherence to approved study timelines and budget while maintaining the highest standards of quality.
KEY ROLES AND RESPONSIBILITIES
Overall study execution of one or more complex clinical trials, including global clinical trials. Develop study timelines. Lead study start-up, general study management, and close out, including ongoing CRO performance management and quality oversight
Develops and executes clinical operational strategy aligned with corporate objectives
Reviews and provides technical input on key clinical documents (protocols, ICFs, IB, CSRs, etc.)
Serves as the primary point of escalation for CRO and vendor issues, leading risk mitigation efforts and driving timely resolution.
Responsible for the overall quality of the TMF for assigned clinical trials. Ensure all study documents are collected, inventoried, and filed in accordance with ICH GCP and sponsor requirements.
Assist in the preparation and follow-up of in-house and on-site clinical site and study vendor quality audits, as well as regulatory authority inspections.
Develop requirements/specifications for outsourcing to vendors. Works with the Program Management team to review vendor proposals, contracts, scope changes/change orders, and budgets for accuracy with respect to the clinical trial protocol and trial activities.
Reconcile vendor invoices for accuracy as needed.
Oversee clinical monitoring (site qualification, site initiation, interim monitoring, clinical trial closeout visits) and other vendor activities to confirm the integrity, accuracy, and accountability of trial activities.
Oversee clinical and research lab data, ensuring compliance with the protocol and study manuals,
Coordinate with CRO and data management for database cleaning, interim lock, and final database lock, and ensure data timelines are met. Participate in reviewing tables, listings, and figures for the interim analysis or the final data output.
Coordinate with the CMC team for investigational product (IP) supply management activities and resolution of IP issues identified at clinical sites during clinical trial.
Compile clinical trial operations materials and updates for consultants, Scientific Advisory Board, and Curevo Board of Directors.
Contributes to the development of abstracts, presentations, manuscripts, and other external forms of communication.

May represent Clinical Operations at cross-functional meetings, CRO Governance Meetings, Senior Leadership Team meetings, and Board of Directors Meetings.
Foster collaborative relationships with internal and external stakeholders, including Clinical investigators, KOLs, CROs, and other outside parties.
Identify opportunities for improving the efficiency and effectiveness of clinical trial operations, develop strategic recommendations, and lead process improvement initiatives to enhance overall performance and execution.
Working with the Head of Clinical Operations, assist in department-level resource planning
Hire, manage, and coach a team of clinical operations personnel
Other activities may be assigned as required
REQUIRED QUALIFICATIONS
BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy).

Minimum of 10 years clinical trial experience in the pharmaceutical, biotech industry, clinical trial site, or CRO, with at least 5 of those years having overall responsibility for managing clinical trial studies
Experience with management of CRO across large global trials, including oversight of performance and quality metrics
Experience in the set-up and management of third-party vendors.

Experience with phases I, II, and III clinical trials.
Experience executing phase III, global clinical trials within approved timelines and budget
PREFERRED QUALIFICATIONS
Experience supporting regulatory submissions and participating in Health Authority inspections
KNOWLEDGE, SKILLS, AND ABILITIES
Thorough knowledge of FDA, CFR, and ICH GCP requirements and other regulatory requirements.

Demonstration of exceptional clinical trial management, with strong strategic oversight to ensure program execution is delivered on time and within budget.
Proven interpersonal skills with the ability to build strong relationships cross-functionally and with external stakeholders, including clinical sites, vendors, consultants, and CROs.

Proven leadership and team-building skills. Ability to build, manage, coach, and motivate a study team
Demonstrated success in proactive risk mitigation and proposing and implementing innovative solutions to challenges
Proficiency with MS Office products Word, Excel, PowerPoint, Outlook) and other electronic systems (CTMS, EDC, and eTMF). Experience with Smartsheet is desirable.

Flexibility in work hours as needed to accommodate international collaborators or significant meetings/events.
Up to 25% travel (US and international) may be required.

PHYSICAL DEMANDS
Performing job responsibilities requires the ability to use hands and fingers to handle or feel and to manipulate keys on a keyboard. Occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Ability to read and type while sitting in front of a computer up to 4 hours at a time. This job requires close vision. May occasionally have to lift, tug, and pull up to 25 lbs.
WORK ENVIRONMENT
This job operates in a professional office environment. This role routinely uses standard office equipment, including computers, phones, photocopiers, filing cabinets, and fax machines.
Curevo offers its employees a generous range of compensation and benefits.
The salary range for this position is $220,000 - $235,000 annually. The salary range may vary based on Curevo's compensation practices and an applicant's qualifications and experience.
Employees have the opportunity to earn an Annual Discretionary Bonus as well as being eligible to participate in Curevo's Discretionary Equity Awards Plan. Our Employee Benefits program includes medical, dental, and vision plans, effective on the first of the month after your hire date, Flexible Spending Account, Health Savings Account, company provided Life and AD&D Insurance as well as LTD Insurance, a 401(k) Plan (eligible on day 1) with company match, cell phone reimbursement, and a variety of supplemental benefits that you may choose to elect. We have a Flexible Vacation Plan, a Paid Sick Leave Plan, and earn 1 hour of sick time for every 30 hours worked, plus 10 paid holidays per year.
At Curevo, we believe the highest-performing teams include people from diverse backgrounds and experiences who respectfully challenge one another and enjoy working and engaging together. We are committed to building an open, diverse, and inclusive culture for all employees.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
Curevo is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status, or any other characteristics protected under applicable federal, state, and local laws.
About Curevo Vaccine
Curevo Vaccine is a clinical-stage biotech company pioneering the development of vaccines for unmet needs. Our overall goal is to bring a safer, well-tolerated, highly effective shingles vaccine to the market with a high-yield manufacturing process for rapid global availability.
Attention: Search Firms / 3rd Party Recruitment Agencies

The Talent Acquisition / HR team manages the recruiting for all positions at Curevo Vaccines. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to Curevo Vaccine will be considered the property of Curevo Vaccine. Curevo Vaccine will not be responsible for any fees associated with unsolicited resumes.
Recruiters are requested not to contact or present candidates directly to our hiring managers or employees and doing so may jeopardize eligibility to work on future positions.

Apply

Vacancy posted 4 days ago

Similar jobs that could be interesting for youBased on the Director, Clinical Operations in Bothell, WA vacancy

Director of Clinical Operations
$128.86k - $161.08k
...Director of Clinical Operations - Endoscopy Center Location: Edmonds, Washington Schedule: Monday-Friday | No Weekends, No Nights, No Holidays, No Call Salary: $128,856 - $161,075 Are you a nursing leader who thrives on...
Suggested
Local area
Monday to Friday
2 days per week
Medix
Edmonds, WA
4 days ago
Supervisor Health Plan Operations - USFHP
...payment integrity processes under the supervision of the Director of USFHP Health Care Operations. Responsibilities include ensuring accurate and timely... ...valued – they're invaluable. Join our team at Pacmed Clinics DBA Pacific Medical Centers and thrive in our culture of...
Suggested
Minimum wage
Contract work
Shift work
Night shift
Providence Health & Service
Bothell, WA
2 days ago
Director, Supply Operations
$203.76k - $236.09k
...Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in... ...undisclosed solid tumor targets. Position Overview The Director, Supply Operations will lead and develop Immunome's Supply Operations function...
Suggested
Contract work
Afternoon shift
Immunome
Bothell, WA
1 day ago
Director / Senior Director, IT Operations & Enterprise Services
$210.11k - $290.46k
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best... ...solid tumor targets. Position Overview The Director / Senior Director, IT Operations & Enterprise Services will lead the function responsible...
Suggested
Full time
Work at office
Remote work
Immunome, Inc.
Bothell, WA
4 days ago
Clinic Operations Manager - Seattle
...JOB MISSION The mission of the Clinic Operations Manager at ACES is to elevate the standards in the treatment of Autism by providing... ...and satisfaction, while collaborating with HR and Clinical Directors to address staffing needs and retention. Additionally, the position...
Suggested
Work at office
ACES
Bellevue, WA
1 day ago
Senior Director, Clinical Development
$342.56k - $389.13k
...Senior Director, Clinical Development Bothell, Washington, United States Immunome is a clinical-stage targeted oncology company committed... ...activities. Collaborate cross-functionally with clinical operations, regulatory, project management, manufacturing, and business...
Immunome
Bothell, WA
3 days ago
Senior Manager, Patient Services Operations
$161.44k - $195.34k
...Senior Manager, Patient Services Operations Bothell, Washington, United States Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of...
Immunome
Bothell, WA
22 hours ago
Regional Clinical Operations Coordinator
...Description Patterns Behavioral Services is hiring a Regional Clinical Operations Coordinator in Lynnwood, WA! The Regional Clinical... ...Coordinator plays a critical role in supporting the Regional Clinical Director’s oversight of clinical quality, compliance, and operational...
Full time
Part time
Traineeship
Patterns
Lynnwood, WA
2 days ago
Head of Operations & Business Management
$92.9k - $129.2k
.... A team where everyone makes play happen. Featuring Operations Manager Electronic Arts Kirkland As our Featuring... ...product marketing, UA. You will report to the Business Management Director. This is a hybrid role based out of a North American office,...
Full time
Temporary work
Work at office
Local area
3 days per week
Electronic Arts
Kirkland, WA
4 days ago
Operations Manager
$98.12k - $142.09k
...Operations Manager At Landis+Gyr, we don't just manage energy—we lead the transformation toward a smarter and more sustainable energy future. With a net revenue of USD 1.73 billion in FY 2024, and a presence in over 30 countries across five continents, Landis+Gyr empowers...
For subcontractor
Work at office
0003 Landis & Gyr
Kirkland, WA
2 days ago
Operations Supervisor
$43.58 - $51.39 per hour
...The Operations Supervisor (OS) is the zone-level supervisory leader responsible for the direct oversight, evaluation, and development... ...the operational link between the Field Supervisor layer and the Director of Operations, ensuring accountability, standards of compliance...
Hourly pay
Full time
Immediate start
All shifts
Shift work
Night shift
Northwest Ambulance
Mountlake Terrace, WA
3 days ago
Director, Recruiting - Operations & IT
$182k - $242k
...responsible for building the world-class talent powering our Operations and IT organizations. We partner closely with Operations, Supply... ...while hiring at global scale. About the Role: The Director, Recruiting is a strategic leader responsible for scaling CoreWeave...
Permanent employment
Temporary work
Casual work
Work at office
Remote work
Flexible hours
CoreWeave
Bellevue, WA
3 days ago
Landscape Operations Manager
...Job Description We are seeking an experienced Landscape Field Manager to oversee field operations, project scheduling, quality assurance, and issue resolution for landscape construction projects. The ideal candidate has a strong background in building hardscape...
Classic Landscaping + Nursery
Kirkland, WA
3 days ago
Field Operations Supervisor (TE4)
...Field Operations Supervisor (Transportation Engineer 4) The Washington State Department of Transportation (WSDOT) is a multimodal agency with a global reputation for excellence. Our dedicated workforce plans, designs, builds, and operates an integrated transportation...
Work experience placement
Work at office
Remote work
Flexible hours
Night shift
Weekend work
State of Washington
Lake Forest Park, WA
4 days ago
Director of Talent- Programs & Operations
$182k - $242k
...Director of Talent- Programs & Operations Livingston, NJ / New York, NY / Sunnyvale, CA / San Francisco, CA / Bellevue, WA CoreWeave is The Essential Cloud for AI™. Built for pioneers by pioneers, CoreWeave delivers a platform of technology, tools, and teams that enables...
Permanent employment
Temporary work
Casual work
Work at office
Remote work
Flexible hours
Shift work
CoreWeave
Bellevue, WA
22 hours ago
Operations and Systems Coordinator
...construction, and maintenance. We're looking for a detail-oriented Operations and Systems Coordinator to improve our admin processes,... ...landscaping or construction. Full-time, reports to Administrative Director. Key Responsibilities Systems Management: Roll out and...
Full time
Work at office
Classic Landscaping + Nursery
Kirkland, WA
22 hours ago
Public Works Supervisor - Water Operations
...Public Works Supervisor - Water Operations We are seeking a skilled and forward-thinking Public Works Supervisor - Water Operations to lead water distribution operations, emergency response, and field maintenance programs that keep our community's critical infrastructure...
For contractors
Flexible hours
GovernmentJobs.com
Bothell, WA
4 days ago
Supervisor Clinic Operations - PacMed
$31.43 - $48.08 per hour
...Description Supervisor, Clinic Operations Pacific Medical Centers Lead with purpose and drive operational excellence across a dynamic... ...day. Under the direction of the Practice Manager and Director of Operations provides leadership and management for the...
Minimum wage
Full time
Local area
Shift work
Pacific Medical Centers
Kenmore, WA
4 days ago
Operations Specialist
$30 - $35 per hour
...Akkodis is seeking an Operations Specialist for a Contract job with a client in Bothell, WA. The ideal candidate must have strong experience in product lifecycle management (PLM), document control, and engineering operations, along with the ability to coordinate...
Hourly pay
Contract work
Temporary work
Local area
Akkodis
Bothell, WA
22 hours ago
Director of Finance and Operations
...Job Description Job Description The Director of Finance and Operations is a strategic leader responsible for driving financial performance, operational efficiency, and scalable infrastructure across the organization. This role oversees finance, operations, legal...
Temporary work
Work at office
Local area
Worldwide
3 days per week
Educative, Inc.
Bellevue, WA
2 days ago
Veterinary Medical Director
$220k - $260k
...Medical Director – BluePearl Pet Hospital, Reno, NV BluePearl Pet Hospital in Kirkland, WA is seeking a collaborative, engaged, and... ...confident, collaborative veterinary professional with several years of clinical experience An enthusiastic relationship-builder, both in-...
Temporary work
Internship
Relocation package
BluePearl Pet Hospitals
Kirkland, WA
2 days ago
Clinical Nutrition Manager - Hospital
$131k
...Clinical Nutrition Manager - Hospital REAL Food re-fined. Clinical Nutrition Manager... ...with the Food and Nutrition Services Director. Strong communication between clinical and... ...Lead and supervise clinical nutrition operations and Registered Dietitian teams across facilities...
Full time
Contract work
Temporary work
Monday to Friday
Thomas Cuisine
Kirkland, WA
1 day ago
Clinical Management Manager
...professional services, helping organizations worldwide transform their operations, enhance their growth, and deliver sustainable outcomes across... ...effectiveness. Our work spans across strategy, operations, clinical optimization, regulatory compliance, and technological...
Live in
Work at office
Local area
Worldwide
Accenture
Kirkland, WA
2 days ago
Behavioral Health Supervisor
$84k - $105k
...Health Center located in Bothell, WA . Lead behavioral health services as a full-time supervisor providing direct clinical care to employees at an on-site health center in Bothell. Serve as the site's Wellbeing Ambassador , championing mental...
Hourly pay
Full time
Contract work
Temporary work
Bank staff
Local area
Premise Health
Bothell, WA
3 days ago
Global OMS Fulfillment Architect and Practice Leader
$163k - $413.6k
...ecosystem partnerships with leading OMS platforms such as Manhattan (OMS/POS), Fluent Commerce, Blue Yonder OMS, and others. You operate at the intersection of strategy, sales, technology, and innovation, acting as a trusted advisor to clients while driving growth,...
Work experience placement
Live in
Work at office
Local area
Accenture
Kirkland, WA
3 days ago
HVAC Operations Manager
$130k - $150k
...a n exciting career opportunity for an ambitious, team-oriented professional who is interested in joining our team as an HVAC Operations Manager. You will be responsible for the supervision of residential HVAC Technicians and Installers to effectively provide service...
Blue Flame Heating, Air, Electric
Mountlake Terrace, WA
22 hours ago
Public Works Operations Manager
...Public Works Operations Manager The Public Works Operations Manager is responsible for the management of assigned divisions within... ...and fleet. Under the direction of the Public Works Operations Director, the Public Works Operations Manager is a middle management position...
Contract work
Seasonal work
Work at office
Local area
Monday to Friday
Shift work
GovernmentJobs.com
Kenmore, WA
11 hours ago
Manager, Digital Claims Operations
$118.9k - $202.1k
...our Healthsource blog: . Help redefine how claims work gets done—at scale and with purpose. As the Manager, Digital Claims Operations , you’ll lead the design and operational delivery of automation and AI-enabled workflow solutions that replace manual, repetitive...
Premera Blue Cross
Mountlake Terrace, WA
5 days ago
HR Operations Specialist
$30 per hour
...The HR Operations Specialist serves as a Human Resources Consultant with deep expertise in performance management and HR consulting, using data, automation, and emerging technologies to enhance how HR delivers value. In this role, you partner closely with HR teams, managers...
Contract work
Temporary work
Local area
Monday to Friday
Aston Carter
Kirkland, WA
3 days ago
Senior Healthcare Business Development Manager - Seattle, Tacoma, Everett, WA
...offering the most advanced O&P solutions, clinically differentiated programs and unsurpassed... ...Care segment is the largest owner and operator of O&P patient care clinics nationwide.... ...with Hanger Clinic team including Area Directors, Group Practice Leaders, and administrative...
Full time
Contract work
Part time
Local area
Remote work
Flexible hours
Hanger Clinic
Kirkland, WA
4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Director, Clinical Operations. Be the first to apply!