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, Taiwan or Singapore

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 strategiesDevelop and implement regional clinical operations strategies aligned with global business objectivesServe as the regional expert for clinical development regulations and trial execution.Leads, manage, motivates and sets direction for operational staffBuild high-performing team and drive performance management, staff training and operational excellenceEnsure Clinical Operations Department personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirementsEnsure adherence to local regulatory requirements and oversee inspection readiness and support regulatory auditsProvide leadership and oversight on projects to ensure delivery according to timelines, budgets and quality metricsInteract with Project Manager and/or DPM, as representatives of the Clinical Operations function, in the escalation and resolution of clinical study issuesOptimize the profitability of Clinical Operations Department to meet or exceed budget targetsPartner 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 metProvide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals and deliverables) to assigned Clinical Operations Line ManagersIdentify and escalate impacts to project scope, resources, schedule or budget through standard methodsParticipate in bid defence meetings, support proposal development, and provide operational insights into feasibility and cost modelling for the regionCollaborate with Business Development to expand regional footprint and client baseConduct 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 performanceBe active in the general and strategic management of the businessManages workload of supervised staff with continued assessment and adjustment as neededProvides 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 positionExpert knowledge of GCP/ICH guidelines and the clinical development processFluency in English and Mandarin is required

Other Required:

Extensive experience of building and leading international teams in a global, cross-functional clinical management environmentExperience 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 settingExcellent organizational skills, attention to detail, and a customer service demeanourExperience in managing clinical aspects of complex and global trialsAbility 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 techniquesProven experience in people managementEffective mentor and coach with proven ability to identify individual development needsProven experience in strategic planning, risk management and change managementAbility to work closely with business unit leadership to understand customer's needsStrong analytical skills and business acumenExecutive presence with ability to confidently deliver complex presentations to senior management or clientsHigh level of integrity and must inspire and demand the highest standards from a professional and ethical perspective.Demonstrated leadership track record and effective interpersonal skillsAbility to lead and inspire excellence within a teamAbility to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiencyResults oriented, accountable, motivated and flexibleExcellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skillsFocused 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 performanceExcellent presentation, verbal and written communications skillsIn depth proven experience in pharmaceutical and/or device research requiredProven experience in delegating while fostering cohesive team dynamicsDemonstrated successful independent negotiation and conflict management strategies

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.

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. 

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

---