Job Description

[Senior/Director, Clinical Operations] - Hummingbird Bioscience (Full-time position \xe2\x80\x93 Singapore based location)
ABOUT HUMMINGBIRD BIOSCIENCE Hummingbird Bioscience is a data-driven precision biotherapeutics team discovering and developing transformative biologic medicines for hard-to-treat diseases. The Hummingbird Bioscience model combines computational and systems biology and wet lab drug discovery in a multi-disciplinary, collaborative environment spanning initial discovery through clinical development. We harness this integrated approach across target identification and patient selection, enabling our team to increase the efficiency of translating novel scientific insights while reducing the inherent risk in drug discovery and development. At Hummingbird Bioscience, our commitment to rigorous science, teamwork, and intellectual integrity underpins our passion to accelerate the journey of new drugs from concept to clinic.
Our highly experienced teams in the US and Singapore span antibody discovery, pharmacology, production and clinical development. For more information, please visit www.hummingbirdbioscience.com, and follow Hummingbird Bioscience on LinkedIn, Twitter and YouTube.
ABOUT THE ROLE We are looking for a Senior/Director to lead our clinical operations team and be responsible for clinical trial delivery. The candidate will initially directly mange clinical studies and implement 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\xe2\x80\x99s Standard Operating Procedures (SOPs). As the number of clinical studies increase, the candidate will be expected to build the clinical operations team to ensure the timely delivery of global clinical studies to a high quality and within budget. This will be a permanent role for the right candidate with ample opportunity to grow within the company.
KEY RESPONSIBILITIES

• Responsible for the day-to-day progress of clinical trials and acting as the clinical pivot for the trials
• Ensure clinical sites are conducting research according to the clinical protocol, local regulations, Code of Federal Regulations (CFR), ICH and Good Clinical Practice (GCP) guidelines
• Management of site activities including monitoring, recruitment, enrollment, data collection and data entry
• Participate in vendor selection, management and oversight
• Escalate identified risks to the VP of Clinical Development or appropriate stakeholder and follow through to resolution
• Support preparation of data and other information for internal and external presentations; participate in internal and external team meetings to share updates on progress of activities
• Contribute to the development of study training and project management materials including databases and trackers
• Review site level clinical documents (ICFs, IRB approvals, etc.) and clinical monitoring reports; review and maintain study 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 and clinical sites to ensure clinical data is entered appropriately
• Draft and work with appropriate stakeholders to implement company standard operating procedures (SOP) on clinical operations
• Support Health Authority Inspections and Inspection preparedness, including participating in co-monitoring activities which may involve travel
• Line management responsibilities for clinical operations managers
• Responsible for all aspects pertaining to the training and development of the clinical operations team
• Provide necessary support to the clinical operations team to resolve escalations and ensure the successful delivery of clinical studies
• Support Hummingbird HR and Finance departments in the initial set up of the company\xe2\x80\x99s Australia business entity, if needed.
• Additional responsibilities as assigned

ESSENTIAL QUALIFICATIONS

• More than 8 years of clinical operational experience in planning and executing clinical studies within the biopharmaceutical industry.
• Successful track record in ensuring rapid study 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 in Australia is essential
• Prior experience within a CRO as a senior Clinical Research Associate or Project Manager 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
• Understanding of the drug development process from pre-IND through registration
• Excellent 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 fast-paced start-up environment
• Line management experience with a track record in building a clinical operations team is preferred
• Availability to travel to clinical trial sites in Australia and, if based in Australia, to company headquarters in Singapore is required with potential travel up to 25% of the time
• Experience with managing an Australian business entity will be highly advantageous.
• Must be located and authorized to work in Singapore or Australia (Sydney or Melbourne preferred

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\xe2\x80\x99s 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 \xe2\x80\x98Apply for this Job\xe2\x80\x99 to submit your application.
For further enquiries, please email us at careers@hummingbirdbio.com.
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.

• Health insurance