KaloBios is a biopharmaceutical company dedicated to improving the lives of patients with innovative therapies. Our mission is to advance medical care using Humaneered, monoclonal antibodies.
KaloBios' Humaneered antibodies are next generation, customized antibodies designed to overcome challenges limiting today's marketed antibody products. Using our expertise, our antibodies are customized to enhance a desired effect or reduce a possible undesired effect.
Our pipeline is comprised of three Humaneered antibodies. These antibodies are being tested in four clinical development programs focused on treating serious respiratory diseases and cancer. We use a patient-targeted approach utilizing or developing a screen or diagnostic method to identify those patients most likely to benefit from our treatments. Ultimately, this approach could result in better treatments than current therapies.
We are recruiting a Clinical Project or Program Manager (depending on experience level) to run our ongoing Phase I/II study of KB004 in hematologic malignancies. KB004 targets the receptor tyrosine kinase, EphA3, which is expressed on hematologic and solid tumor cells, but not normal cells. The position reports to the Head of Clinical Operations. The ideal candidate will be an individual with experience in oncology, who is comfortable being responsible for managing all aspects of the assigned clinical study(ies). This is a great opportunity to get hands-on business experience in a small, innovative company.
At KaloBios, the Clinical Project/Program Manager is responsible for the day-to-day management of one or more clinical studies. The position is pivotal to ensuring that our clinical studies are executed in compliance with good clinical practices and the study protocol, and that studies are developed and managed on time and within budget. The position works closely with the Medical Monitor, Drug Safety, Clinical Data Management, Regulatory/QA, and other cross-functional team members, clinical CROs and staff to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget.
Key Job Responsibilities (depending on the stage of the project):
Leads a multi-functional study team responsible for the implementation of a clinical study or clinical program
Manages the day-to-day clinical operations of the clinical study/program
Participates in the CRO and vendor selection process
Manages all aspects of the relationship with CRO(s) and other clinical vendors throughout clinical study lifecycle
Site management (either directly or through a CRO)
Allocates CRA resources, oversees all site visit activities and reviews CRA site visit reports. May accompany CRAs to oversee activities at clinical study sites
Negotiates site CDAs, budgets and contracts with support from Legal
Study management (either directly or through a CRO)
Prepares/writes clinical protocols and amendments under the guidance of the medical monitor
Develops template informed consent forms and reviews and approves site specific informed consent forms
Performs feasibility assessment and contributes to the investigator/site selection process
Creates, reviews and refines clinical study management and vendor oversight plans
Leads study data review for quality and consistency with study objectives
Oversees submission of study-related documents to the Trial Master File
Maintains effective relationships with clinical collaborators and clinical site personnel
Manages study timelines, budgets, and resource allocation; reviews and reconciles financial aspects of study to ensure the study is executed within the timeline and budget
Assists in providing cross-functional operational plans and cost estimates
Provides clinical study and/or program status reports on a timely basis to the project team and senior management
Position may include up to 20% domestic and/or international travel
Background and Experience:
Bachelors degree in a scientific field or equivalent and 7+ years of clinical experience
5+ years direct experience managing industry sponsored clinical studies, including field monitoring experience
Thorough knowledge of ICH/GCP guidelines, FDA requirements for INDs, NDAs, and drug approval process
Excellent analytical, negotiation, and problem-solving skills
Outstanding organizational, communication, and presentation skills
Thorough understanding of clinical study activities including data management, drug safety, biostatistics, and medical writing
Strong influencing skills are required
Exhibited ability to be proactive and agile in a fluid company environment
Pro-active and transparent communicator
Candidates must have a proven track record in a fast-paced, dynamic environment and be able to multi-task and communicate at all levels within the organization