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Vir Biotechnology, Inc. · 1 day ago

Associate Director, Clinical Operations

San Francisco, CA

Full-time

Onsite

Lead/Staff, Director/Executive

$176K/yr - $246K/yr

10+ years exp

Vir Biotechnology is a clinical-stage biopharmaceutical company focused on discovering and developing medicines for serious infectious diseases and cancer. The Associate Director, Clinical Operations will independently lead global and complex clinical trials, managing the Study Management Team and ensuring successful execution and conduct of clinical trials.

BiotechnologyHealth CareMedicalTherapeutics

Comp. & Benefits

No H1B

Responsibilities

Provide strategic input and leadership in study set-up and execution of highly complex oncology clinical trials. May support multiple trials

Establish and continuously monitor study timelines and budgets, promptly escalating significant risks or changes, as appropriate

Develop and manage study contracts, budgets and timelines

Author/review core study documents including protocol and Informed Consent Forms

Manage CRO, central lab, systems vendors, and ancillary vendors to ensure on target deliverables

Develop study plans and relevant study document templates for study teams

Able to support regulatory strategy and assess trial/program impact and RFIs from multiple countries

May lead RFP process, budget development, and study forecast/planning including timelines

May perform sponsor oversight site visits

Manages oversight of clinical monitoring activities including monitoring trip report review and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics

Reviews monitoring trip reports and track resolution of all action items

Manage team with direct reports within therapeutic area

Clinical Operations lead on cross functional project teams and alliance teams

Stakeholder management with internal business partners, key opinion leaders, and external partners on clinical studies

Qualification

Clinical developmentOncology clinical studiesFDA guidelinesGCP complianceRegulatory complianceStudy managementBudget managementTeam leadershipStakeholder managementVendor managementCross-functional collaborationCommunication skills

Required

Bachelor of Science degree is required, preferably in the life sciences

10+ years of clinical development experience in the biotech/pharmaceutical industry

Extensive experience working on oncology clinical studies

Experience in managing and leading clinical studies both in early phase through late stage of development

Experience in leading all stages of clinical trials including start up, maintenance and closeout

Thorough understanding of FDA, EMEA, and ROW ICH and GCP guidelines, as well as thorough understanding of cross-functional clinical processes including and not limited to data management, biostatistics, medical monitoring, drug safety, regulatory affairs

Experience with regulatory compliance audits and inspections

Experience directing and leading in a complex team environment

Ability to function at a high level when leading a group or managing staff, but ability to manage day-to-day details when needed

Flexibility to travel domestically and internationally

Benefits

Health and welfare benefit plans

Non-accrual paid time off

Company shut down for holidays

Commuter benefits

Childcare reimbursement

Education reimbursement

401K match

Lunch each day in the office

Company

Vir Biotechnology, Inc.

At Vir Biotechnology, Inc., we leverage the immense potential of the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer.

Founded in 2016

San Francisco, California, USA

201-500 employees