We are a privately held Biotechnology company based in Seattle is focused on developing novel vaccines for the treatment of infectious disease. The Company’s technologies regulate immune responses by targeting dendritic cell biology with combinations of proprietary vectors and adjuvants. The Company is building a clinical operations team that will support the development of a broad platform of vaccines. We currently are hiring for the following positions:

Director of Clinical Affairs

JOB DESCRIPTION

This position will have primary ownership and responsibility for the conduct of clinical investigations and related activities. The candidate will demonstrate the ability to understand all areas of study planning, evaluation, documentation associated with clinical trial activities. Provide leadership and management for development and implementation of clinical protocols. Prepare relevant sections of protocol, IND’s, BLA’s and other documents for submission to the FDA.

DUTIES AND RESPONSIBILITIES

• Provides leadership to ensure the conditions essential for conducting clinical investigations and activities associated with it.
• Supervises training programs to assure consistency and compliance in monitoring of clinical investigations.
• Prepares and distributes 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.
• Drives the preparation and review and revision of departmental policies and SOP’s to ensure compliance with corporate policies, good clinical practice procedures (GCP’s), or regulations of governmental agencies.
• May assist with preparation and execution of Investigator meetings.
• Prepares 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.
• Trains, develops and supervises clinical staff.
• Negotiates contracts and budgets for assigned clinical investigations.
• Develops and reviews study protocols and CRF’s.
• Participates in internal/external audits.
• Responsible for producing final study reports.
• Participates in dissemination of clinical information to the clinical team members, as appropriate.
• Provides leadership and assists as appropriate in managing the clinical research department in an effective manner.
• Serves on cross teams for evaluation of new clinical research strategies.
• May act as a company spokesperson regarding publication and presentations of clinical research findings.
• Coordinates cross functional efforts to improve clinical development.
• Identifies issues that may impact the overall project plans and initiates contingency plans as appropriate.
• Directs departmental resource planning, budgeting, and timeline setting to meet the companies needs.
• Provides clinical support in working with the FDA, including pre-market approval submissions and responses to FDA questions.

QUALIFICATIONS

• 10+ years experience of progressively increasing clinical research experience with the /pharmaceutical industry
• Experience and knowledge of GCP, GLP and cGMP related to the biologics industry.
• Excellent strategic planning, organizational and creative problem-solving skills.
• Strong oral and written communication skills with a demonstrated ability to participate in presentations to investigators, FDA, investors, funding sources, and other internal and external business contacts.
• Scientific expertise in reading, assessing and interpreting preclinical and clinical data which can be translated and used in commercialization activities including development of clinical claims, advertising claims, promotional claims and new product opportunities.

Regulatory Affairs Manager/Quality Assurance Specialist

JOB DESCRIPTION

Responsible for managing all aspects of regulatory affairs and quality assurance activites associated with the development and evaluation of Vaccsys products. Prepare relevant sections of INDs, BLAs and other documents for submission to the FDA. Provide quality management in compliance with regulatory requirements for Vaccsys products.

DUTIES AND RESPONSIBILITIES

• Preparation and submission of all regulatory documents necessary to support clinical development of Vaccsys products, including submissions to FDA and international regulatory agencies.
• Prepare study reports, annual reports and necessary correspondence with FDA and other agencies.
• Provide assistance to clinical and cross-functional project teams in all aspects of quality assurance pertaining to development of Vaccsys products
• Maintain quality sustem records, including Standard Operating Procedures
• Diverse responsibilities will entail working on multiple projects and a broad spectrum of documents and reports, and regular interaction with cross-functional internal and external disciplines.
• Ideal candidate must: like variety, be detailed oriented and well organized, and be able to work effectively with complex data.
• Excellent communication skills, both verbal and written, are key.
• Strong knowledge of regulatory compliance guidelines are also key.
• Role includes representing the Regulatory department as a participant and contributor to multi-disciplinary project teams and in regular and ad hoc meetings.

QUALIFICATIONS

• Bachelor’s degree (advanced degree [MS] preferred) with regulatory experience.
• Three to six years of pharma or biotech industry experience. (Years of experience required will depend upon a combination of training and experience.)
• 1+ years of Regulatory Affairs experience, including, but not limited to, compilation of CMC submissions and organization of INDs.
• Exceptional writing skills.
• Proven flexibility, multi-tasking and organization skills to handle multiple projects.
• Strong collaborative team skills

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