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Apogee Therapeutics · 4 days ago

Associate Director, Clinical Operations

United States

Full-time

Hybrid

Lead/Staff, Director/Executive

$180K/yr - $195K/yr

8+ years exp

Apogee Therapeutics is a biotechnology company founded in 2022, focused on developing differentiated biologics for inflammatory and immunology indications. They are seeking an Associate Director of Clinical Operations to manage and execute clinical trial programs, ensuring compliance with regulatory guidelines and overseeing vendor relationships.

BiotechnologyLife ScienceMedicalTherapeutics

Responsibilities

Accountable for overall management of multiple clinical trials

Serves as the central point 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 progress 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

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, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc

Review and approve contracts, work orders and invoices prior to submission to senior management for approval

Lead 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 Oversight and performance management for all 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-lead Sponsor/CRO operational meetings with CRO to ensure deliverables are on track

Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, close 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 oversee 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 all 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

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.)

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 Oversight of all vendors, Data Integrity, and Risk Assessment requirements

Participates and responds to Quality Assurance and/or regulatory authority inspection audits

Ensures all assigned studies are always Inspection Ready

Accountable for working closely with Biometrics, Pharmacovigilance, Medical, and the CRO to participate in data review, and oversee adherence to study timelines and data quality. Oversight 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. Oversight of protocol deviations/variations

In conjunction with the CRO, oversee and drive the metrics on CRA source data verification

Qualification

Clinical trial managementGCP complianceVendor managementRegulatory processesBudget forecastingBiotech experienceProject managementCommunicationLeadershipCollaborationProblem-solving

Required

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

Significant knowledge of pharmaceutical industry, drug development and regulatory processes

Experience developing all Clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets

Leader with growth mindset, 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 develop 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 Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences

Preferred

2+ years' experience in Biotech industry strongly preferred

Benefits

Market competitive compensation and benefits package, including base 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

Apogee offers regular all team, in-person meetings to build relationships and problem solve