Senior Clinical Project Manager / Associate Director of Clinical Operations

Senior Clinical Project Manager / Associate Director of Clinical Operations - Hummingbird Bioscience

Full time position - Singapore/ Australia / Shanghai

ABOUT HUMMINGBIRD BIOSCIENCE

Hummingbird Bioscience is a biotherapeutics company working at the interface of artificial intelligence and human innovation to discover and develop transformative medicines for hard-to-treat diseases. Hummingbird Bioscience’s computational and systems biology technologies have generated a pipeline of innovative clinical-stage monoclonal antibodies and antibody-drug conjugates in oncology and autoimmunity.  At Hummingbird Bioscience, the commitment to rigorous science, teamwork, and intellectual integrity underpins our passion to accelerate the journey of new drugs from concept to clinic.

For more information, please visit www.hummingbirdbioscience.com, and follow Hummingbird Bioscience on LinkedIn, X (formerly Twitter), and YouTube.

ABOUT THE ROLE

We are looking for a Project Manager/Associate Director to lead our clinical studies and be responsible for clinical trial delivery. The candidate will initially manage regional and/or global clinical studies including China, and serve as an operations lead in accordance with company standard operating procedures (SOPs) for clinical operations. The candidate will work with study teams internally, and externally with vendors such as CROs and other 3rd party vendors on feasibility, planning, initiation, maintenance and closeout of clinical studies according to GCP, ICH and Hummingbird Bioscience’s Standard Operating Procedures (SOPs).

The Senior Clinical Project Manager / Associate Director Clinical Operations will report directly to the Senior Director of Clinical Operations, or where applicable, Vice President, Program and Clinical Operations.

KEY RESPONSIBILITIES

Project Director 

• Responsible for the project management and day-to-day progress of clinical trials to maximize trial timelines, recruitment and ensure trials are executed with high quality and within budget.
• Ensure trials are being conducted according to the clinical protocol, local regulations, Code of Federal Regulations (CFR), ICH and Good Clinical Practice (GCP) guidelines.
• Management of trial and site activities including monitoring, recruitment, enrollment, data collection and data entry.
• Participate in vendor selection, management and oversight including review, negotiation and maintenance of clinical trial vendor service agreement, budget work orders and change orders.
• Participate in internal and external team meetings to share updates on progress of activities
• Development and tracking of key performance indicators (KPIs) relating to clinical studies.
• Contribute to the development of trial training and project management materials
  including databases and trackers
• Review trial and site level clinical documents (ICFs, IRB approvals, etc.) and clinical monitoring reports; review and maintain trial level clinical plans (including, but not limited to, site monitoring plan, deviation plan, data management plan)
• Manage the Trial Master File (TMF) and perform ongoing quality reviews
• Liaise with the CRO, KOLs and clinical sites to support site relationships, and ensure clinical data is entered appropriately
• Support Health Authority Inspections and Inspection preparedness, including participating in co-monitoring activities which may involve travel 
• Collaborate closely with internal and external (as needed) clinical trial functional leads to ensure successful clinical trial delivery
• Trial invoice review and contract/budget tracking
• Support the Head of Clinical Operations in trial delivery
• Supervises and manages all aspects of clinical trials to ensure that corporate and department goals/objectives for clinical development programs are met on time and within budget
• Coordinate with finance team to manage and participate in the program budget, and to aid in budget planning and forecasting
• Participate in budget and new business activities by assisting with the review of RFPs, assessing trial strategies, and attending bid defense

ESSENTIAL QUALIFICATIONS

• Bachelor’s degree in Science, Life Sciences, Medical Science, or equivalent
• More than 3 years of clinical operational experience in planning and executing clinical studies within the biopharmaceutical industry.
• Successful track record in ensuring rapid trial start up; and effective management of CROs and vendors to ensure timely delivery of studies to a high quality and within budget.
• Experience with management of oncology studies is essential.
• Clinical Operations experience in APAC and SEA is required
• Regional experience in US is highly preferred
• Understanding of oncology clinical data with the ability to interpret, analyze and present clinical data
• Detailed knowledge of ICH guidelines, including Good Clinical Practice (GCP), and regulatory and ethics framework in Australia is essential
• Excellent documentation and interpersonal skills with the ability to build strong relationships across internal and external partners
• Ability to work independently and with the flexibility to handle workflow in a fastpaced start-up environment
• Availability to travel to clinical trial sites and to company headquarters in Singapore is required with potential travel up to 25% of the time

OUR MISSION & VALUES

Our fast-growing biotechnology company is committed to discovering and developing important new drugs for cancer and autoimmune diseases, and living by our values: Excellence, Determination, Teamwork, Intellectual Integrity and Audacity.

JOIN US AT THE FRONTIER OF DRUG DISCOVERY AND DEVELOPMENT

We are looking for passionate and motivated individuals committed to solving important, complex problems. We are committed to the personal and professional development of our team and offer robust learning and development programs. Hummingbird Bioscience understands the need for flexibility for our team and offers a generous paid time off program with flexibility to support employees through different life stages. We invest in our team’s health by offering competitive benefits including health and dental insurance, and a comprehensive and holistic employee assistance program. We foster a more collaborative, productive, and sociable culture with on-site lunches and snacks. Finally, we believe in creating social impact beyond our business through corporate social responsibility initiatives.

Are you ready to join us on our mission to discover and develop important new drugs for cancer and autoimmune disease? Click on ‘Apply for this Job’ to submit your application.

For further enquiries, please email us at [email protected].

Hummingbird Bioscience is firmly committed to Equal Employment Opportunity (EEO) and to compliance with all Singapore and US federal, state and local laws and/or guidelines that prohibit employment discrimination on the basis of age, race, color, gender, sexual orientation, gender identity, ethnicity, national origin, citizenship, religion, genetic carrier status, disability, pregnancy, childbirth or related medical conditions, marital status, protected veteran status and other protected classifications.