Director, Clinical Operations

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Due to our continued growth we are seeking a Director, Clinical Operations to be located in China or Taiwan

The Director, Clinical Operations, provides leadership to the Clinical Operations Department (Clinical Trial Management/Clinical Monitoring) across countries. This role ensures the delivery of high quality, timely and cost-effective clinical trial operations in compliance with ICH-GCP, Federal regulations, SOPs and other applicable regulations. The Director collaborates with executive management on the ongoing development of the Clinical Operations Department and contributes to the business plan at both the tactical and strategic levels.

Essential functions of the job include but are not limited to:

• Work with Precision for Medicine Senior Leadership and Clinical Operations leadership to develop corporate and departmental business strategies
• Develop and implement regional clinical operations strategies aligned with global business objectives
• Serve as the regional expert for clinical development regulations and trial execution.
• Leads, manage, motivates and sets direction for operational staff
• Build high-performing team and drive performance management, staff training and operational excellence
• Ensure Clinical Operations Department personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
• Ensure adherence to local regulatory requirements and oversee inspection readiness and support regulatory audits
• Provide leadership and oversight on projects to ensure delivery according to timelines, budgets and quality metrics
• Interact with Project Manager and/or DPM, as representatives of the Clinical Operations function, in the escalation and resolution of clinical study issues
• Optimize the profitability of Clinical Operations Department to meet or exceed budget targets
• Partner with Global Resourcing teams for assessment and management of Clinical Operations team members under their remit, to ensure that established cost, time, and quality goals are met
• Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals and deliverables) to assigned Clinical Operations Line Managers
• Identify and escalate impacts to project scope, resources, schedule or budget through standard methods
• Participate in bid defence meetings, support proposal development, and provide operational insights into feasibility and cost modelling for the region
• Collaborate with Business Development to expand regional footprint and client base
• Conduct evaluations and implement required changes for all projects (including mid-project recovery of at risk projects, re-scoping, postponement, or cancellation)
• Analyse, measure and report KPIs and lead continuous improvement of Clinical Operations function within their remit.
• Recognize, exemplify and adhere to company values that centre on our commitment to quality, our people, clients and performance
• Be active in the general and strategic management of the business
• Manages workload of supervised staff with continued assessment and adjustment as needed
• Provides on-going feedback, development and coaching of Clinical Operations line managers and individual contributors including annual performance reviews

Qualifications:

Minimum Required:

• Bachelor's degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred.
• A minimum 12 years of experience in clinical research, including extensive clinical and line management experience or proven competencies for this position
• Expert knowledge of GCP/ICH guidelines and the clinical development process
• Fluency in English and Mandarin is required

Other Required:

• Extensive experience of building and leading international teams in a global, cross-functional clinical management environment
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) and clinical software experience (CTMS, eTMF, EDC etc)
• Excellent communication and interpersonal skills to effectively interface with others in a team setting
• Excellent organizational skills, attention to detail, and a customer service demeanour
• Experience in managing clinical aspects of complex and global trials
• Ability to travel domestically and internationally including overnight stays

Preferred:

• Advanced degree

Competencies:

• Leads, inspires, and ensures appropriate ownership and accountability in a highly virtual and matrix-managed organization
• Working knowledge of clinical operations tools and techniques
• Proven experience in people management
• Effective mentor and coach with proven ability to identify individual development needs
• Proven experience in strategic planning, risk management and change management
• Ability to work closely with business unit leadership to understand customer's needs
• Strong analytical skills and business acumen
• Executive presence with ability to confidently deliver complex presentations to senior management or clients
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective.
• Demonstrated leadership track record and effective interpersonal skills
• Ability to lead and inspire excellence within a team
• Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
• Results oriented, accountable, motivated and flexible
• Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
• Focused on continuous improvement, with the ability to make proactive assessments on how to make processes more efficient and people more effective in delivering results with appropriate quality and timeline performance
• Excellent presentation, verbal and written communications skills
• In depth proven experience in pharmaceutical and/or device research required
• Proven experience in delegating while fostering cohesive team dynamics
• Demonstrated successful independent negotiation and conflict management strategies

#LI-OS1 #LI-Remote

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.