Job Description

About The Role

Responsible for directing the Safety Assessment department to ensure the attainment of operational excellence and quality. Ensures that departmental policies objectives and operation and communication network of the company supports the highest level of compliance and efficiency possible. Provides business development support by participating in client meetings and assisting Study Directors with study design to meet client needs.

Youll Do Here

• Leads the Good Laboratory Practices (GLP) compliance initiatives.

• Oversees the development and implementation of strategic plans policies and procedures to ensure department programs will meet or exceed internal and external customers needs and expectations.

• Assures the development review revision and implementation of SOPs SSPs policies training manuals and/or checklists relating to technical procedures facility issues and data generation.

• Provides administrative approval of Protocols.

• Ensures appropriate scientific review of study reports and other deliverables.

• Participates in client meetings to support business development and client management activities.

• Mentors staff regarding drug development requirements client management and study design.

• Directs and approves departmental resources personnel fiscal assignments and allocations.

• Designates Study Director to meet study objectives.

• Replaces the Study Director promptly if it becomes necessary to do so during the conduct of a study.

• Acts as company representative to regulatory agencies including the FDA and local regulatory agencies.

• Ensures departmental staff is compliant with corporate directives.

• Plans and directs activities to ensure operational efficiency and economy.

• In conjunction with administrative personnel reviews activity operating and budget reports to guide and direct programs or operations as required.

• Manages Study Directors in Safety Assessment.

• Is responsible for the overall direction coordination and evaluation of the department.

• Approves department purchase orders and requests.

• Initiates and responds to client inquiries regarding company policy and procedures.

• Other duties as assigned.

What Youll Need to Succeed

• Ph.D. in relevant biomedical field MD DVM or Masters degree in combination with appropriate training and experience.

• Minimum of seven years experience in evaluating pharmaceutical preclinical safety and toxicology studies in the pharmaceutical/biotech industry in contract toxicology research organizations or similar organizations.

• Previous experience in management or supervision of groups or teams.

• Minimum of 5 years experience in conducting developing and managing preclinical safety and efficacy programs.

• Experience in writing and presenting preclinical safety reports to support regulatory submissions.

• At least 8 years related experience and/or training; or equivalent combination of education and experience in industry / contract research organization (CRO) drug development.

• Ability to read analyze and interpret scientific and technical journals financial reports and legal documents; the ability to respond to common inquiries or complaints from customers regulatory agencies or members of the business community; the ability to write speeches and articles for publication that conform to prescribed style and format. Excellent written and verbal communication skills including the ability to create and present high-quality scientific presentations.

• Ability to apply advanced mathematical and statistical evaluations to scientific and business data for interpretation and presentation to staff and upper management.

• Requirements include training in GLP regulations and knowledge of ongoing toxicology regulatory laws rules and notices on guidelines concerning preclinical drug development and business communication.

• Continual GLP training.

• Demonstrated ability to lead people and get results through others.

• Ability to organize and manage multiple priorities. Problem analysis and problem resolution at both a strategic and functional level.

What We Offer

The salary range estimated for this position is $126000 - $200000. Please note that salaries vary within the range based on factors including but not limited to prior relevant experience skills education certification location as well as internal equity and market data.

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences Benefits Package Includes:

• Health/Dental/Vision Insurance Plans

• 401(k)/RRSP with Employer Match

• Paid Vacation and Holidays

• Paid Sick and Bereavement Leave

• Employee Assistance & TelehealthPrograms

Altasciences Incentive Programs Include:

• Training & Development Programs

• Employee Referral BonusProgram

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Required Experience:

Director

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