Associate Director, Clinical Data Management

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.
Work Requirement
This role will be based out of our San Francisco location and is hybrid with a minimum of 3 days per week onsite.
Key Responsibilities

• Manages and develops Clinical Data Managers across studies by providing oversight, guidance, mentoring and feedback.
• Manages/coordinates Clinical Data Management project activities performed by vendors/CROs, as appropriate, to ensure delivery on time, within scope, and with quality.
• Assists in the selection of vendors/CROs (e.g. review RFPs, bid defense meeting).
• Independently develops/reviews and guides team members through development of relevant Data Management documents.
• Independently performs and guides team members through the data cleaning and database lock process in an efficient and timely matter.
• Ensures resource availability and manages all relevant stakeholders.
• Understands critical tasks and milestones to ensure Data Management deliverables are met per study timelines.
• May program non-system edit check (NSECs, data listings as appropriate), runs SAS programs, reviews SAS logs, and generates output and/or SAS Data Listings as appropriate for SAS skill level. Mentor less proficient SAS users as appropriate.
• Leads studies and guides team through DM lifecycle tasks.
• Evaluates, directs department Initiatives and innovations to improve CDM processes; represents CDM through working groups (Internal, external) and initiatives where thorough knowledge of CDM practices/processes are required.
• Align with and support management and corporate objectives.
• Utilizes experience and leadership skills to provide guidance to other team members.
• Actively works to foster an environment of effective and collaborative working relationships amongst employees, management and external partners.

Education and Experience

• BA or BS in a relevant field and a minimum of 8 years' related experience or an equivalent combination of education and experience; and at least 2 years management experience.
• Proven interpersonal skills and the ability to work collaboratively as a member of cross functional team. Ability to establish and maintain effective and working relationships
• Previous experience providing leadership to Data Management personnel team
• Effective organizational skills and the ability to work effectively in a high paced, fast changing environment. Results oriented
• Technologically savvy; ability to quickly learn and implement new information, standards, regulations, tools, methods, or software as it relates to position and profession
• Detail oriented; performs quality and accurate work
• Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, user acceptance testing, medical coding, the drug development process
• Previous relevant electronic systems as such EDC, IXRS, RTSM
• Previous vendor/CRO management experience
• Preferred:
  • Previous experience with ePRO, SharePoint, J-Review, Business Intelligence tool
  • Database development experience

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.
The US base salary range for this full-time position is $158,000 - $242,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location.
The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate's location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).
Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. This role is also eligible for a competitive benefits package that includes:

• 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 RRSP / 401K 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.
Date: Jan 30, 2024