Job Description

Job Title: Director, Clinical Trials Location: Remote Business Unit: Health Department: CRO Job Type: Full time
Allphase Clinical Research has an exciting opportunity to join our diverse team as the Director, Clinical Trials! We offer competitive salaries, a generous benefits package and the chance to be part of a great and growing team!
Summary of Position:

• Responsible for the efficient management of the company\xe2\x80\x99s overall clinical operations and scientific affairs. Analyze current and future trends in the industry, identify risks/vulnerabilities and ensure that the company remains competitive.
• Responsible for establishing the company\xe2\x80\x99s research and development activities in support of the company\xe2\x80\x99s business strategy including building partnerships and relationships within pharmaceutical industry, scientific community and with key opinion leaders.
• Develop and implement departmental strategic plans that support the organization\xe2\x80\x99s vision and goals; translate the strategic plan to staff to ensure support; and modify the plan in response to changing internal and external factors.
• Identify opportunities for new value creation and assist the senior leadership team in the aggressive and successful growth of the business.
• Evaluate external business development opportunities from a clinical/scientific perspective. Establish personal and corporate credibility with prospective clients and the industry at large.
• A wide degree of creativity and latitude is expected.

• Plan and direct department objectives, initiatives, policies, procedures, systems, etc. needed to move in strategic direction and to ensure long-term business viability.
• Oversee the planning, development and implementation of improvement strategies for the operational management of assigned departments.
• Establish and maintain appropriate systems for reporting operational metrics.
• Participate in the forecasting and analysis of project budgets, provide economic basis for senior management decisions, to improve operational and financial performance
• Contribute to the evaluation and development of the company operational strategy and performance by identifying trends and highlighting opportunities.
• Provide timely and effective issue resolution and escalation as needed

• Oversee clinical studies to ensure they are conducted in compliance with ICH-GCP, client expectations and/or Allphase SOPs and policies, and are executed within budget
• Endeavour to proactively identify and resolve potential issues, provide timely and effective reactive issue resolution and escalation as needed
• Maintain an overview of execution and delivery of studies and/or projects from a functional perspective. Provide detailed metrics on project progress.
• Perform CSM activities when needed to move project deliverables and timelines forward
• Assess departmental billability on an ongoing basis and adjust resourcing as required to maintain billability at appropriate levels (includes review of timesheets and expense reports as well as project burn rates)
• Assist with the development and management of project specific budgets
• Identify when project Scope Changes are required and facilitates their preparation and administration

• Identify, train, develop, and retain talented individuals; create a learning environment that ensures staff realize their highest potential allowing the organization to meet future challenges.
• Resource forecasting and recruitment of new staff members as required to meet new and existing project requirements
• Contribute to the development and employee awareness of the corporate mission, values and goals
• Provide leadership and mentoring, as well as open communication to maximize staff motivation.
• Provide ongoing feedback, conduct annual performance evaluations for direct reports, and implement performance improvement plans as necessary.
• Hold staff rigorously accountable for achieving their objectives.
• Build and maintain a culture of people who take disciplined action and are willing to go above and beyond to fulfill their responsibilities.
• Design and deliver an agile organizational structure that enables the movement of people and resources quickly to capture new market opportunities.
• Provide direction, guidance and leadership to assigned departmental staff.
• Process and/or oversee the preparation and processing of contractor agreements and invoices.
• Evaluate and process leave requests for direct reports.

• Maintain and build positive working relationships with current as well as new potential clients.
• Oversee and communicate the corporate image to customers, at trade shows, networking events, and through development of corporate collateral, press releases, internal communications and related activities.
• Attend client meetings to discuss new opportunities and assess customer satisfaction, and coordinate the effort required to maintain a high level of satisfaction.
• Support development and defend business proposals.
• Participate and/or oversee the preparation of proposals/Work Orders and Scope Changes for clients.
• Fulfill other duties as required.

• Clinical trial design, protocol development and medical writing (e.g. investigator brochures, manuscripts, posters, clinical study reports)
• Provide guidance, oversight, and support preparation of regulatory submissions.

• In-depth knowledge of ICH-GCP guidelines and applicable regulations
• Excellent interpersonal and team building skills
• Energetic, enthusiastic, motivated, self-driven, diplomatic
• Ability to interact effectively and professionally with team, clients and partners
• People management skills (leadership, coaching, influence)
• Ability to manage people and stressful situations in a calm and constructive manner
• Ability to maintain composure and function effectively under pressure
• Ability to objectively evaluate and resolve complaints based on facts and in the best interest of the organization
• Project management skills & financial acumen with respect to managing study budgets
• Customer focused, analytical and a problem solver
• Effective time management skills and ability to manage competing priorities
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Demonstrated proficiency in Microsoft\xc2\xae Office
• English and French communication skills (oral and written), excellent presentation skills
• Knowledge of clinical trial requirements and demonstrated ability to analyze and understand protocols and customer needs to develop comprehensive and accurate proposals

• Must provide a secure home-office setting and be able to use standard office equipment, including a computer (finite movements such as typing and other office functions)
• Requires mental stamina to maintain attention to detail despite interruptions, and vision to read printed materials and a computer screen
• Must be flexible to work extended hours, including weekends and evenings, to support operations requirements
• Valid driver\xe2\x80\x99s license and passport required
• Willing and able to travel internationally