Singapore, SGP, SGP
Senior Director, Clinical Development Operations APAC
Company Description
Zymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation, bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks' suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.
Why Work With Us
Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
Zymeworks is proudly headquartered in our brand new, net-zero facility located in the vibrant Main St biotech hub of Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and the Bay Area.
About the Position
The Director, Clinical Development Operations APAC is responsible for the oversight of multiple Global Clinical studies being conducted In the APAC region and other regions across one or more therapeutic portfolio. This role is also responsible for providing strategic vision and direction and ensures completeness and consistency of processes required for successful life cycle management for all phases of clinical trials across the therapeutic portfolio. The position will also entail managing the Singapore office.
This position will report to VP, Clinical Development Operations, is open to qualified candidates in Singapore, and is eligible for our Hybrid Work Policy, with a minimum of 3 days per week onsite.
Key Responsibilities
- Provide direction and guidance to Clinical Development Operations study teams responsible for clinical trial planning, Implementation, management and close-out with specific responsibilities for the APAC region.
- In collaboration with the VP, Clinical Development Operations, is responsible for Clinical Operations strategy, clinical trial execution, timelines, resource planning, budget forecasting and management
- Providing leadership within the Clinical Development Operations department, acting as a point of escalation and supporting cross-functional issue resolution, as required.
- Providing strategic, tactical and operations input to Clinical Development Teams.
- Tracking project team performance and monitoring progress toward ZW goals.
- Works closely with Clinical Finance to oversee and coordinate all budgetary activities for assigned programs including budget creation, forecasting and reporting accruals.
- Works closely with project teams to develop clinical trial protocol and associated clinical forms, including Case Report Forms, SAE Forms, etc. for assigned clinical trial.
- Review clinical sections of regulatory submission documents and assist with publications and presentation of clinical data.
- Oversees project plans and project timelines and monitors against project progress
- Provide oversight for site budget development to study teams.
- Tracks and reports study progress, risks and mitigations to cross functional department staff and senior management
- Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among study teams.
- Ensures compliance with Key Performance Indicator (KPI); Key Risk indicators (KRI); and Key quality indicators (KQI) for assigned programs.
- Prepare and follow-up of in-house and on-site quality audits, as well as, regulatory authority inspections.
- Participates in the selection, training and evaluation of study personnel (contract and internal) to insure the efficient operation of the function.
- Manages employees, monitors performance, encourages growth and facilitates the development of team members’ skills through training, mentorship opportunities and sharing of knowledge.
Education and Experience
- University degree in a relevant discipline, and a minimum of twelve (12) years of clinical trials experience with at least 5-7 years of management experience in pharmaceutical, biotech or CRO setting and clinical trial management experience. Preference given to candidates with experience inin APAC regions. Related experience in drug development, and on-site monitoring or an equivalent combination of education and experience.
Skills and Abilities
- Experience in Phase I-III clinical trials
- Experience with CRO management and outsourced clinical model
- Oncology clinical research experience required
- Strong knowledge of ICH/GCP and regulatory guidelines, especially In APAC region
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
- Strong leadership skills with the proven ability to manage, develop and empower employees
- Excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment
- Proficiency with MS Office products (MS project and Smartsheet, Word, Excel, PowerPoint, Share point) and other electronic systems (CTMS, EDC and eTMF)
- Experience with development of eCRF required
- Ability to travel as required (up to 20%)
- This role Is not open for relocation support
Total Rewards
We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.
Our team enjoys:
- Industry leading vacation and paid time off
- Excellent health and wellness benefits
- Zymelife health and wellness benefits
- Paid time off to volunteer in your community
- Matching country specific pension savings program
- Employee Share Purchase Program
- Employee Equity Program
All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.
NOTE TO AGENCIES: Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.