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Clinical Project Manager, Development

Lpath, Inc.

Location:
San Diego, CA
Posted Date:
8/11/2014
Position Type:
Full time
Job Code:
Clinical Project Manager
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Project Manager, Development,

Job Description

Company Description:

Lpath, Inc. is a San Diego based therapeutic antibody company, and the category leader in lipid-targeted therapeutics, an emerging field of medicine that targets bioactive signaling lipids for treating a wide range of human disease.  Lpath's ImmuneY2™ drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease.  The company has developed three drug candidates: iSONEP™, a monoclonal antibody against sphingosine-1-phosphate (S1P), is currently in a Phase 2 trial for wet AMD; ASONEP™, also a monoclonal antibody against S1P, is in a Phase 2 clinical trial as a treatment for renal cell carcinoma; and Lpathomab, an antibody against lysophosphatidic acid, is a preclinical drug candidate that holds promise in pain, neurotrauma, and other diseases.  Lpath entered into an agreement with Pfizer Inc. (NYSE: PFE) in 2010 that provides Pfizer an exclusive option for a worldwide license to develop and commercialize iSONEP.  For more information, visit www.Lpath.com.

Position Summary:

Under the direction of the Development Project Lead for a given biological compound, the candidate will be accountable for the day-to-day operations including successful initiation, management and completion of clinical trials in accordance with regulatory requirement and quality standards for the individual early development project(s) in Phase 1 and 2.  The candidate will lead implementation of clinical operations activities through interaction with internal colleagues and/or external consultants and service providers to integrate project efforts across disciplines.  He/she will provide oversight of Contract Research Organizations (CROs), laboratory vendors, and other clinical trial service providers.

Specific Responsibilities & Duties:

•   Leads the Clinical Trial Team consisting of members from other functional areas (e.g., Data Management, Medical Safety, Regulatory Affairs, Clinical Supplies)
•   Establishes study milestones and ensures accurate tracking and reporting of study metrics
•   Ensures that trial timelines, budget, and quality metrics are met
•   Ensures study conduct is compliant with ICH/GCP/local regulations
•   Develops and implements study plans (e.g., Monitoring, Recruitment and Project Management plans) and review additional plans (e.g., Data Management, Safety Monitoring, Statistical Analysis, CRF Completion Guidelines)
•   Direct interaction with IRB/EC, CROs and other clinical vendors
•   Generates study documents such as informed consent and newsletters
•   Accountable for timely handling of AEs & SAEs by Medical Safety Officer in compliance with regulatory requirements
•   Provides operational expertise in clinical trial development and execution in preparation of clinical protocols, clinical study reports, and CRFs
•   Plans and conducts study specific training (e.g., CRO training, Investigator Meeting, Site Initiation Visits)
•   Participates in vendor identification, selection and qualification
•   Leads effort in vendor budget negotiation, development of scope of work and contract execution
•   Manages study vendors (e.g., IRB/EC, CRO, Central Laboratory, Central Reading Center, EDC); ensuring deliverables are met and issues are proactively identified and resolved
•   Performs quality control activities (i.e., co-monitoring visits, Trial Master File audits)
•   Approves vendor invoices and ensures timeliness of payments
•   Arranges DSMB meetings and generates Investigator Alert letters
•   Oversees and forecasts inventory of both study drug and other clinical supplies
•   Provides study-specific direction and mentoring to Clinical Trial Associates and other support staff as appropriate
•   Proactively identifies clinical operations risks, assess their magnitude, and proposes plans/strategies to mitigate them
•   Addresses unanticipated operational issues and brings them to resolution
•   Other duties as assigned

Requirements

Qualifications and Skills:

•   B.S. degree or higher in Biological or Physical Sciences
•   5+ years of experience in the pharmaceutical industry in Clinical Operations positions
•   Previous experience in pharmaceutical clinical development of biologics would be strongly desirable
•   Enthusiasm, willingness to learn, strong work ethic, broad scientific interests and attention to detail
•   Sound problem-solving abilities with creative input to solutions
•   Works effectively either independently or within project teams to multi-task with changing priorities and work under tight deadlines
•   Ability to think globally and strategically
•   Demonstrated ability to work in a small-company team environment
•   Excellent oral/written communication skills

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