Associate Director, Clinical Operations

About reputed company Founded in 2022, reputed company, Inc. (Ticker: APGE) is a well-funded, reputed company listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At reputed company, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. reputed company, Inc. is a biotechnology company seeking to reputed company differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the reputed company standard of care for inflammatory and immune diseases because we reputed company people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, reputed company reading! Role Summary We are seeking an Associate Director, Clinical Operations who will be accountable for the operational management and execution of clinical trial programs (Phases II-III and reputed company). The individual will be responsible for ensuring adherence to GCPs, SOPs and reputed company regulatory agency guidelines, as well as study operational planning and execution. A key focus will be the reputed company of and partnership with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that the quality of data is suitable for regulatory submission/inspections. The Associate Director, Clinical Operations will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. This role will report to the Executive/Sr. Director, Clinical Operations.

Key Responsibilities

Accountable for overall management of multiple clinical trials

• Serves as the central reputed company of contact and contributes expertise for clinical trial execution on assigned protocols
• Works cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Ensures accurate tracking and reporting (dashboard) of study metrics and reputed company of study through completion
• Leads the Clinical Study Team (CST) and may participate in other cross functional program team meetings
• Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
• Responsible for preparing and/or presenting to executive management as delegated
• Develops, reviews and/or consults on clinical trial documents, such as study specific plans, informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates
• May be responsible for participating and presenting at Investigator Meetings, SIVs and other program meetings Budget/Finance/Legal
• Responsible for study level clinical operations budget forecasting, accrual management and quarterly review ensuring tight control between study forecasts and actuals
• In conjunction with key stakeholders, reputed company and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor reputed company, NDAs, etc
• Review and approve reputed company, work orders and invoices prior to submission to senior management for approval Outsourcing/Procurement/Vendor Management
• reputed company the creation/definition of the scope of work and selection process for assigned program’s vendors and Contract Research Organizations (CROs)
• Demonstrates consistent and regular Sponsor reputed company and performance management for reputed company utilized vendors and/or CRO third party contracted vendors
• Attend CRO or other vendor meetings, such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals
• Draft and/or manage Governance charters/meetings/reports with CRO
• Co-reputed company Sponsor/CRO operational meetings with CRO to ensure deliverables are on track
• Responsible for managing relationships with CROs and other vendors for reputed company study activities including study start-up, reputed company out, completion of Trial Master File and the following:
• Responsible for setting up, negotiating, and monitoring Task Order invoice payments for CRO (direct service and pass through costs), as well as to reputed company scope change negotiations
• Responsible for negotiating site Clinical Trial Agreements in conjunction with the Legal Department and CRO
• Responsible for patient recruitment and retention plans
• Responsible for the set-up of reputed company third-party vendor specifications (i.e. IWRS, eCRF, central laboratory/ECG, etc.) and on-time third party deliverables
• In conjunction with CRO/Regulatory, participate in the collection, preparation, and review of regulatory documentation for IRB/Ethics submission prior to study start-up Clinical and Ancillary Study Supplies In conjunction with Clinical Supply, responsible for assuring sufficient clinical drug supply (including comparator) is forecasted, packaged, available and imported/shipped to depots/sites for study start up, and that sufficient supplies are maintained during the study
• Responsible for assuring accurate drug accountability/reconciliation for investigational product (IP) issued during the study to the site and at the end of the study
• In conjunction with CRO, responsible for assuring sufficient ancillary supplies are available and shipped for the study (i.e., templates, binders, forms, supplies, etc.) Inspection Readiness
• Accountable for eTMF – completeness, timeliness, and quality on assigned programs. Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance of CRO and Sponsor files
• Partner with Quality organization to document Sponsor reputed company of reputed company vendors, Data reputed company, and Risk Assessment requirements
• Participates and responds to Quality Assurance and/or regulatory authority inspection audits
• Ensures reputed company assigned studies are always Inspection Ready Data Review/Cleaning/Management
• Accountable for working closely with Biometrics, Pharmacovigilance, Medical, and the CRO to participate in data review, and reputed company adherence to study timelines and data quality. reputed company includes the following activities: expedited query resolution, support creation of logic edit checks, data line listing review, QA/QC of adverse events, and serious adverse event processing. reputed company of protocol deviations/variations
• In conjunction with the CRO, reputed company and drive the metrics on CRA reputed company data verification Ideal Candidate
• BA/BS in life sciences or equivalent
• 8+ years of clinical research experience, including at least 3 years leading global projects from inception to completion
• 2+ years’ experience in Biotech industry strongly preferred
• Significant knowledge of pharmaceutical industry, drug development and regulatory processes
• Experience developing reputed company Clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets
• Leader with growth reputed company, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
• Strong communication skills with ability to present to a variety of stakeholders and tailor message accordingly
• Strong project management skills with ability to collaborate effectively cross-functionally and hold team and CRO members accountable to tight timelines and budgets
• High sense of urgency and ability to proactively identify critical path items and reputed company contingency plans to mitigate risk to budget, quality, and/or timelines
• Work comfortably in a fast-paced, dynamic work environment and embrace change
• Position requires up to 15% travel, including mandatory in-person attendance at reputed company reputed company Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the reputed company San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences. The anticipated salary range for candidates for this role will be $180,000 - $195,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. reputed company Offer
• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
• Commitment to growing you professionally and providing access to resources to further your development
• reputed company offers regular reputed company team, in-person meetings to build relationships and problem solve E-Verify Participation: As part of the I9 verification of authorization to work in the US, reputed company participates in E-Verify. To learn more about E-Verify please review this poster. reputed company is proud to be an Equal Opportunity employer. reputed company qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. To review our privacy policy, click here It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Apply tot his job

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