FierceBiotech and FiercePharma Jobs
Manager of Clinical Affairs - Discovery Solutions LLC Recruiting
Nov 26
Location: Bridewater, NJCategories: Clinical
Position Description
Located in central NJ, this is a biopharmaceutical company dedicated to developing breakthrough biologic medicines in the area of oncology. The Company has utilized the many advances made in the fields of molecular biology, oncology, genomics, and antibody engineering to build a novel pipeline of product candidates designed to address specific genetic mechanisms involved in cancer growth and development.
Their goal is to become a fully-integrated biopharmaceutical company that has the capability and resources to take its novel pipeline compounds and develop them from the research and development stage through to commercial manufacture, marketing and sales. With their first innovative cancer drug on the market and late stage clinical candidates soon to be, they have cooperative agreements with several big pharmaceutical companies to help market their drugs. A solid, fast growing midsized company which incorporates the best of both worlds, security with room to grow.
Currently looking for a: Manager, Clinical Affairs
GENERAL SUMMARY
Under minimal supervision, manages the conduct of one or more clinical investigations. Performs assigned responsibilities to ensure timely completion of departmental goals and objectives. Prepares and reviews management reports, ad hoc reports, summaries, analyses on clinical databases. Coordinates and participates in co-monitoring of these investigations. Assists with special projects as assigned.
ESSENTIAL DUTIES AND RESPONSIBILITIES
•Manages the conduct of assigned clinical investigations and activities associated with it.
•Manages the interaction of appropriate departments and staff to support and maintain the clinical investigations.
•Assists with the management of the co-monitoring of assigned clinical investigations and coordinates/participates in the co-monitoring of assigned clinical investigations as needed.
•Oversees the Quality Control review of clinical trial patient databases and clinical files.
•Supervises training programs to assure consistency and compliance in monitoring of clinical investigations.
•Prepares and distributes monthly management reports, ad hoc reports, summaries, or analyses as required. Prepares status reports for assigned clinical investigations.
•Prepares drug usage projections and tracking for assigned clinical investigations as requested.
•Participates in the periodic review and revision of departmental policies and SOP’s to assure compliance with corporate policies, good clinical practice procedures (GCP’s), or regulations of governmental agencies.
•Contributes to the selection process of new hires, including reviewing candidates credentials, interviewing candidates, and making hiring recommendations.
•May assist with preparation and execution of Investigator meetings.
•Assists with preparation of department budgets, timelines, and project plans.
•Maintains professional skills by keeping abreast of literature, attending conferences, courses and meetings.
•Maintains knowledge of U.S. and foreign regulations, guidelines, policies and practices for conducting clinical investigations.
•Follows departmental policies, procedures and SOP’s.
•Trains, develops and supervises clinical staff.
•Negotiates contracts and budget for assigned clinical investigations.
•Develops and reviews study protocols and CRF’s.
•Participates in internal/external audits.
•Reviews and participates in finalizing and obtaining approval of final study reports.
•Participates in dissemination of clinical information to the clinical team members, as appropriate.
•May serve on cross teams for evaluation of new clinical research strategies.
ESSENTIAL KNOWLEDGE, SKILLS AND EXPERIENCE
•5-10 years experience of progressively increasing clinical research experience within the pharmaceutical industry.
•Experience in drug development, especially FDA regulations and GCP’s or Associates of Clinical Pharmacology CRA certification.
•Experience in IND/NDA/BLA submissions.
•An advanced degree (M.S. or PharmD) is preferred. A minimum academic degree in Nursing (R.N. or B.S.N.), Life Sciences (B.A. or B.S.), Pharmacy or Medicine. Experience requirements may be less with advanced degrees.
•Ability to resolve and make judgements regarding administrative, scientific and/or clinical problems with minimal supervision.
•Ability to deliver oral presentations and write in a clear, focused, and concise manner.
