This job has closed.

Planet Pharma · 1 day ago

Clinical Trial Lead

San Francisco, CA

Full-time

Hybrid

Director/Executive

10+ years exp

Planet Pharma is a company focused on supporting clinical trials and operational strategies. The Clinical Trial Lead will manage clinical study budgets, timelines, and resources, ensuring compliance with regulations and overseeing CROs and vendors for successful trial execution.

BiotechnologyHealth CarePharmaceutical

Responsibilities

Manages clinical study budget, timelines, and resources, focusing on quality and operational strategies to support study and/or program objectives

Responsible for developing clinical development operational plans in support for the study

Oversees execution of studies in compliance with ICH/GCP, local regulations, and company SOPs

Provides input into study budget forecasting and responsible for invoice and budget tracking for individual studies

Supports the selection, oversight, and management of CROs and other vendors

In collaboration with the CRO, oversees site feasibility/capability assessments

Reviews and provide Clinical Operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate

Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures

Represents the company externally to Investigators, site staff, and Key Opinion Leaders

Represents Clinical Operations related to study-specific discussions with collaborators/partners, as applicable

Performs and documents study level Sponsor Oversight of outsourced clinical activities

Communicates study-status, cost and issues to ensure timely decision-making by senior management

Oversees/collaborates on and contributes to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct

Maintains oversight of departmental and organizational SOPs metrics for study team to ensure compliance

Leads and/or participate in the creation and review of departmental and organizational SOPs and initiatives

Manages the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations

Develops collaborative relationships with key stakeholders; internal and external

Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors

Exercises judgments within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results

Manages internal staffing and performance management, including hiring, training, coaching and performance reviews

Mentors and develops Clinical Operations staff

Proposes innovative ideas to help resolve challenges faced by the study team

Strives for continuous improvement and more efficient ways of working in Clinical Operations

Acts as a role model for the company's core values

Qualification

Clinical trial managementGCP complianceCRO managementBudget managementPharmaceutical developmentProject managementMicrosoft Office proficiencyInterpersonal skillsProblem-solvingCommunication skills

Required

A Bachelors /degree is required; A Bachelor's or Master's in in a scientific discipline is preferred; RN or BSN degree highly desired, equivalent experience may be accepted

Experience in GCP inspections/audits is highly desired

10 years pharmaceutical development experience including managing CROs

3 years previous people management experience is required

Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills

Excellent written and verbal communication skills in addition to excellent project management skills

Experience and understanding of ICH, and GCP

Must be a demonstrated self-starter and team player with strong interpersonal skills

Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint

Some travel required depending on business needs