Associate Director, Medical Research and Grants Operations

Medical Affairs United States


Description

Why Work for Us? 

Innovation. Act with Integrity. Collaboration. Embrace Diversity. 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.

Company Description  

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.

About the Position 

Zymeworks Global Medical and Scientific Affairs Department is seeking a highly motivated individual who is looking to grow her/his career with our company. The Associate Director, Medical Research and Grants Operations is responsible for the successful development and management of high quality and compliant collaborative and investigator-initiated research (IIR) and educational grants programs globally from start-up through close-out activities.     

This position will report to Director, Medical and Scientific Affairs and will be located in either Seattle, WA or remote. This position will also work closely with Director, Global Medical and Scientific Affairs Operations.

Job Description and Responsibilities

  • Lead operational strategy and execution of the IIR and educational grants programs from review of applications and start-up through receipt of outcomes/deliverables and close-out activities, in high-quality, compliant manner
  • Work in collaboration with medical and scientific affairs colleagues to develop overall objectives and plans for research and grants programs for each product and/or therapeutic area
  • Maintain communication with investigators and study coordinators during all phases of research regarding study progress reports, issue identification/resolution, safety reports, contractual matters including payments, and collection of required documents
  • Monitor study progress, communicate progress and issues to IIR team members, and initiate corrective and preventative actions when study deviates from agreed upon contract timelines, budgets, or plans
  • Review proposals, protocols, reports, and amendments to ensure compliance and to provide operational feedback
  • Ensure that required safety information are reported and processed according to all applicable SOPs and in collaboration with Global Patient Safety
  • Partner with Supply Chain Operations for study drug management (e. g. projections, requests)
  • Ensure all IIR program records are kept up-to-date and accessible for team use and audit-readiness and maintain all SOPs, processes, and guidelines for IIR program
  • Build and implement new processes, policies, and criteria to manage, evaluate and process incoming grant requests
  • Lead end-to-end communications to internal and external stakeholders throughout entire grant lifecycle
  • Set up and manage research and grant review committee meetings, including preparation of agenda, minutes, decision log, and follow-up regarding action items
  • Work with Legal and Finance business partners to develop and negotiate contracts and payment schedules for IIR and grants
  • Conduct budget review and fair market value analysis of investigator and grant budgets. Evaluate and confirm all research and grant invoices, including for budget reconciliation upon study closure/amendment or grant closure
  • Tracks and communicates key deliverables of research and grants programs to internal stakeholders
  • Implement new research and grant management systems, manage vendor relationships
  • Assist with other duties related to the operations of early access and Phase IV/registry studies, including facilitation and management of cross-functional work-streams 

Qualifications 

  • Bachelor’s degree and 7+ years of experience in IIR and educational grants operations fields or
  • Masters and 5+ years of related experience or
  • PhD/MD/PharmD and 3+ years of related experience
  • Strong science background with experience in oncology preferred
  • Experience with diverse investigator-initiated research study types (interventional, non-interventional and/or registries) and cooperative group studies required
  • Clinical trial operations experience in the pharmaceutical industry or CRO is preferred.
  • Experience in partnering with vendors, managing research and grant management systems (e.g. Polaris, Visiontracker) is required
  • Knowledge of applicable regulatory, legal, compliance standards, reporting, and accreditation requirements (FDA, Sunshine Act, GxPs, clinical trial transparency requirements (e.g. EudraCT), ACCME and CME/CE outcomes assessment (e. g MOORE))
  • Self-motivated and deadline-oriented, able to multi-task and function autonomously in a fast-paced environment
  • Acts with integrity and commitment to compliance, while focusing on delivering results and maintaining strong customer service orientation. 

Additional Information

  • Ability to travel up to 20%

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. 

#LI-PT1