Director of Clinical Development (448-470)

Spectrum Pharmaceuticals, Inc. Irvine, CA

Summary: Direct all activities required to conduct and monitor clinical trials and ensure that Good Clinical Practices (GCP) are followed. Ensure projects are resourced appropriately and employees are trained to meet projects needs. Help formulate effective strategic goals and objectives, and assure implementation and operational integration of those goals and objectives as directed by senior management. Implement successful clinical programs that are completed on time.

Responsibilities:

* Play a leadership role in managing multiples of Phase I through Phase IV clinical research trials across all functional areas of the drug development process.

* Oversee and coordinate the operational aspects of ongoing projects to ensure corporate goals of time, cost and quality performance expectation are met.

* Guide clinical operations in outlining standard operating procedures (SOP) for Clinical Development that facilitate the development of drug research protocols, compliance with clinical/medical standards and compliance with industry standards.

* Lead and motivate clinical staff.

* Develop and review protocols and interact with key external opinion leaders regarding protocol development.

* Find investigators.

* Conduct investigator meetings and site visits.

* Implement and supervise clinical trials, including requests for eligibility and other waivers.

* Monitor clinical trial progress including, but not limited to, drug safety, assessments and tracking of AEs, SAE and protocol deviations. Prepare SAE narratives for submission to regulatory affairs, reconciling SAE database, MedDRA and WHO coding.

* Advise and troubleshoot any medical problems arising at clinical sites.

* Interact with data management to support data entry including assistance with edits.

* Demonstrate leadership and interpersonal skills.

Drug Development Responsibilities:

* Interact with senior management and product team regarding drug development strategy and plan.

* Interact with investigators and key opinion leaders regarding protocol development.

* Write protocols, IB and annual reports.

* Contribute to Clinical Study Reports.

* Write safety section of IND and NDA submissions.

* Help create budgets and progress reports; complete other administrative tasks as required.

Required Skills

Education and Experience:

* Medical Degree required, or PhD with significant experience in Oncology Pharmaceuticals

* Requires Hematology or Oncology experience

* One to three years experience in the pharmaceutical or contract research industries, or two years in academic clinical research

* Knowledge of safety reporting principles, including FDA safety reporting regulations

* Skill in writing narratives

* Experience with safety database coding

* Able to work independently, prioritize tasks efficiently and meet expected time frames

* Able to perform thorough reviews of various medical and legal records in a timely manner

* Able to interact and collaborate professionally with various departments, regulatory agencies and investigators

Availability:

* Must be available to work in the evenings and weekends, as required.

Position Location and/or Territory and Travel

* Position is located in Irvine, CA.

* Position will require occasional travel

Spectrum Pharmaceuticals is an equal opportunity employer, we evaluate qualified applicants without regard to race, color. Religion, sex, national origin, disability, veteran status, and other protected characteristics.

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