Research & Development Scientist Stem Cell Biology, STEMCELL Technologies, Vancouver, British Columbia

Description:

STEMCELL Technologies, the number one biotechnology employer in Vancouver, has immediate openings for Research & Development Scientists in the fields of stem cell research: pancreatic, endothelial, mesenchymal and epithelial.

Duties:

·     Development and characterization of specialized culture media.

·     Development of novel reagents to support stem and progenitor cell growth/differentiation.

·     Design and perform experiments, analyze and present results at R&D meetings.

·     Produce drafts of technical documents for review including R&D Reports, Product Information Sheets, Product Specification Masters, Marketing materials and protocols.

·     Train lab and sales staff in laboratory/product protocols.

·     May provide technical support (product use, protocols) for QC and Manufacturing.

·     May supervise coop/summer student(s).

·     Establish and manage external collaborations.

·     Generate intellectual property, draft patent applications.

·     Make external scientific presentations.

·     Support QMS initiatives, adhere to QMS requirements.

·     May contribute to departmental administration and lab management.

Qualifications:

·     PhD or equivalent in Biology, Biochemistry or a related relevant area with extensive experience in cell biology and practical knowledge of primary cell culture are required.

·     Knowledge of human or mouse stem/progenitor cell culture is very desirable.

·     Experience with in vivo assays and other assays for stem cell studies.

·     Experience with immunocytochemistry and fluorescence microscopy.

·     Excellent verbal and written communication skills.

·     Excellent independent troubleshooting ability.

·     Documented ability to multi-task and work well in a team on a long-term project.

·     A working understanding of tissue specific stem cell biology preferably in human or mouse stem cell research is an asset.

·     Proficiency with primary cell-based assays, media/reagents optimization and the preparation and testing of tissue culture reagents for these assays is an asset.

·     Experience with flow cytometry is an asset.

STEMCELL offers a competitive salary and benefit package and excellent working conditions.

Contact:

If you possess all of the above skills complemented with the required experience and are interested in exploring this career opportunity please forward your resume by fax or email to:

Human Resources

STEMCELL Technologies Inc.

570 West 7th Avenue, Suite 400

Vancouver • BC • V5Z 1B3

Fax: 604.675.7830

Email: humanresources@stemcell.com

Medical Director/ Senior Medical Director, Alexion Pharmaceuticals, Inc., Cheshire, Connecticut

Description:

Alexion is looking for experienced and motivated physicians to lead new and expanding clinical development programs in the areas of hematology, oncology, nephrology, neurology and transplantation. Our medical directors guide the development of new and marketed products in the United States and around the world. These positions report directly to the Chief Medical Officer and are based in key locations in the United States and at our headquarters in Cheshire, CT.

Medical Directors serve as the internal and external medical champions at Alexion with responsibilities in Clinical Development; Trials Planning, Implementation and Follow-Up; Safety Reviews; Post Marketing and Commercial Support Activities.

Depending on experience and therapeutic area, specific responsibilities include:

Drug Development Planning

•Assist in planning the overall strategy (clinical and otherwise) for products in clinical development.

•Assist in IND and NDA filing activities for drug candidates

•Interact with FDA (by teleconference or attendance at meetings).

•Assist in due diligence of potential in-licensing drug candidates.

•Interact with academic experts and advisory panel members at international symposia.

Trial Start-Up

•Assist in protocol development, including protocol outline, protocol and protocol amendments, which will require interaction with Medical Directors, Clinical Project Leaders, Safety Officers, Statistics, Regulatory, Project Management, Clinical Supply and Marketing personnel.

•Participate in investigators' meetings, as well as internal and external educational seminars related to study protocol.

•Oversee recruitment of participating investigators and the compilation and distribution of study start-up packages.

•Identify and interact with outside experts and opinion leaders.

Trial Conduct

•Serve as the primary medical contact with collaborators and opinion leaders.

•Serve as medical expert with internal and external (CRO, independent contractors) staff regarding protocol related issues.

•Assist in developing and monitoring adherence to program timelines (e.g., enrollment, data cleaning, and statistical output timelines).

•Oversee investigator recruitment efforts and resolve recruitment problems in conjunction with the Clinical Project Leader.

•Track and compile patient screening and enrollment information.

•Perform data listings review and assist in study report generation, as needed.

Trial Reporting

•Assisting in creating and reviewing all study related documents, including justification documents, CRF's, study tables and listings, statistical analysis plans, and final study reports.

•Prepare pertinent safety and/or efficacy summaries for official documents.

Budget Responsibilities

•Assist in preparing site-specific study budgets.

•Assist in preparing departmental budgets and short and long term budget projections for ongoing projects.

Safety Review

•Periodically review all study related patient safety data.

•Interact with Safety Officer and Regulatory Affairs regarding reporting of serious adverse event to FDA.

•Visit selected sites, with or without a field monitor, to trouble-shoot, train/retrain staff, if needed.

Post-Marketing Activities

•Serve as internal and external medical champion at Alexion, including serving as a key medical speaker on marketed products in a multiplicity of venues and providing medical and scientific input and support for presentations at international/national and regional meetings, such as Speaker's Training, Advisory Boards, etc.

•Lead discussions with and influence academic and clinical opinion leaders, prescribers, and colleagues at the FDA.

•Interact with internal Pharmacovigilance group in the review of post-marketing safety-related occurrences.

•Define publication strategies and develop medical positioning for the Company's products.

•Manage the marketing product publications program; review content of journal articles and other communication materials, including promotional pieces, from an accurate medical/ clinical/scientific supportability perspective.

•Review medical information/communications responses to FAQs on marketed products.

Experience & Qualifications:

•M.D. degree and board eligibility in internal medicine, hematology, oncology, nephrology, neurology and/or transplantation.

•Industry-based clinical development experience in a pharmaceutical or biotech setting.

•A proven record of direct experience working with clinical trials as an Investigator, Sub-Investigator, or Medical Monitor is desirable.

•Working knowledge of general medicine and drug therapy, including pharmacology, toxicology, trial methodology and clinical pharmacology, and an in depth knowledge and understanding of scientific principles for controlled trials, is essential.

•A high level of professionalism, and the ability and willingness to work effectively in a team setting.

•Knowledge of regulatory requirements for NDA submission and experience interacting with regulatory agencies will be beneficial.

•Ability to travel.

•Strong interpersonal skills with a proven background of interacting successfully with individuals at a variety of functional levels, both internally and externally.

•Excellent written and verbal communication skills.

Contact:

Alexion Pharmaceuticals, Inc.
352 Knotter Drive
Cheshire, CT 06410
United States
www.alxn.com

Alexion Pharmaceuticals is a publicly traded company engaged in the development of novel drugs for the treatment of hematologic disorders, autoimmune diseases, cardiovascular disorders and cancer.

Alexion offers a highly competitive package of base and incentive compensation, group healthcare coverage, tuition reimbursement, relocation assistance, a 401(K) plan.

Alexion is an Equal Opportunity/Affirmative Action Employer.