Director, Clinical Operations

Job description 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. Keywords maintenance-repair-and-operations-mro planning-and-forecasting electrical-engineering-and-planning planning-and-design strategic-planning clinical-trials startups contract-research-organization contract-research-organization-cro conversion-rate-optimization-cro performance-management objectives-and-key-results infiniband-ib risk-management google-cloud-platform good-clinical-practice-gcp audits outsourcing program-management invoicing compliance broker-protocol data-management locks-locksmiths testing-and-analysis chase-mobile-checkout-plus intellectual-property supply-management cabinet-construction-materials-hardware external-workforce advisory-board board-of-directors training-and-development presentations key-opinion-leader-kol process-improvement eye-face-and-head youth-organizations-resources biotechnology third-party-vendors environment-health-and-safety-hsse food-and-drug-administration-fda-or-usfda time-and-attendance team-building microsoft-powerpoint clinical-trial-management-system-ctms electronic-data-capture-edc electronic-trial-master-file-etmf smartsheet hours-of-work trade-shows-events lift-and-shift ecology-environment salary-range policies-and-practices disabilities-ada ethnicity-national-origin sexual-orientation religion-belief-and-spirituality state-local-municipal laws-and-regulations search-and-retrieval recruiting-career-management