Director, Drug Safety & Risk Management

Regulatory Affairs · Seattle, Washington
Department Regulatory Affairs
Employment Type Permanent - Full Time
Minimum Experience Experienced

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics.  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.


Zymeworks is seeking a highly-motivated professional who is looking to grow their career with our company. 


About the Position


The Director, Drug Safety & Risk Management is responsible for the timely review and assessment of safety information to characterize safety profiles for all Zymeworks products, performing medical review and assessment of individual case safety reports performing safety surveillance activities, and leading the build-out of these functions. 


This individual will work closely with senior management, business partners, and cross-functional teams to ensure oversight of critical safety issues and serve as a resource for expert medical guidance for study and program teams. This individual will contribute to aggregate safety reports and key study and regulatory documents. 


This position will report to the Vice President, Regulatory Affairs and will be based in Seattle, WA.


Key Responsibilities


  • Participates in the development of strategic and long- term direction of the department. Works with senior management team to develop and implement programs, strategies and processes. Ensures department and operational activities are aligned with corporate objectives.
  • Leads through example to establish an environment fostering effective and collaborative working relationships.
  • Manages the preparation of operating and personnel budgets and plans. Authorizes expenditures, oversees forecasting activities and communicates anticipated variances to senior management as required.


 ICSR medical review tasks include but are not limited to:


  • Accessing the Argus safety database to perform medical review of ICSRs; ensuring medical completeness and accuracy, MedDRA coding, identifying queries, and preparing Analysis of Similar Events (AOSE), as required.
  • Contributing to solving adverse event reconciliation coding issues/discrepancies.
  • Overseeing vendor ICSR medical review practices. 


Risk Management activities include but are not limited to:


  • Establishing the medical safety and risk management function, leading development of processes to support safety review and governance venues, including defining safety data review packages. 
  • As a key member of safety review and governance venues, prepares materials, presents safety issues and signal evaluations, and proposes risk mitigation strategies.
  • Participates in/lead safety policy discussions to assure communication of benefit-risk considerations and safety surveillance activities including routine review of safety data to detect and evaluate safety signals.
  • Contributes to preparation and review of periodic reports (e.g. DSUR).
  • Supports the preparation and maintenance of Reference Safety Information including Investigator’s Brochure, Company Core Safety Information, and expected terms lists.
  • Participates in protocol development to ensure effective collection of safety data. Reviews and provides medical content and analysis, as needed, for regulatory documents and key study-related documents (e.g. ICF, SMC/IDMC Charters, clinical study reports). 


Alliance management & functional activities:


  • Drives global alignment of risk management practices for Zymeworks products, defines key areas for medical alignment across alliance partnership (e.g., RSI, coding practices), to assure consistency of shared products.
  • Participates in alliance safety teams with external partner(s) including providing input to Pharmacovigilance agreements.
  • Partners with head of Drug Safety Operations to assure completeness and accuracy of safety data collection and ensures compliance with all relevant regulations and internal procedures.
  • Serves as point of contact for medical safety function in regulatory inspections and internal process audits.
  • May manage internal medical review personnel. Monitors performance, encourages growth and facilitates the development of team members’ skills through training, mentorship opportunities and sharing of knowledge.
  • Uses in-depth knowledge of PV science to provide expertise and insight to cross-functional colleagues as appropriate.


Qualifications and Experience


  • MD (board certified/board eligible or ex-US equivalent) and a minimum of 5 years’ relevant drug safety/pharmacovigilance experience in the biopharmaceutical industry setting, or an equivalent combination of education and experience. Oncology safety science experience preferred. Experience with post-market requirements a plus.
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships
  • Strong leadership skills with the proven ability to manage, develop and empower employees
  • Demonstrated knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments
  • Robust knowledge of MedDRA dictionary with relevance to adverse event coding
  • Ability to manage and prioritize multiple projects and demands simultaneously; rapidly adjust to changing priorities and work effectively under pressure
  • Able to think and act strategically, anticipate road-blocks and map out next steps
  • Strong analytical, assessment and problem-solving skills
  • Experience leading teams and managing staff
  • Demonstrated ability to read, analyze and interpret clinical data and information
  • Demonstrated  high level of integrity and ethics
  • Proficiency in use of Excel, Word, PowerPoint
  • Excellent written and spoken English
  • Prior experience with business partners a plus
  • Argus safety database experience an asset


Why Work for Us?


Innovation. Act with Integrity. Collaboration. Care

 

We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.

 

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

 

To learn more about Zymeworks Inc. and our current openings, please visit our website at https://zymeworks.bamboohr.com/jobs/.

 


NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.


 

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  • Location
    Seattle, Washington
  • Department
    Regulatory Affairs
  • Employment Type
    Permanent - Full Time
  • Minimum Experience
    Experienced