- Represents Clinical PK and Clinical Pharmacology line function and works on a multi-functional team (clinical, regulatory, biometrics, etc.) to support late-stage discovery programs from preclinical development to IND filing and throughout clinical development.
- Independently analyzes, interprets and reports clinical PK data as a member of several multidisciplinary development program teams.
- Works with preclinical teams to design PK/TK studies in advance of IND filings.
- Works with clinical teams to design PK components in various study designs, such as first-in-human and drug-drug interaction studies.
- Writes and reviews relevant sections of regulatory and scientific documentation including INDs, Clinical Study Protocols, IBs, SOPs, Statistical Analysis Plans and Clinical Study Reports.
- Maintains a working knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics.
- Develops and maintains a relationship with internal and external clients and scientists.
- Reviewing/Authoring scientific publications, abstracts, and posters.
- Maintain a positive, results-orientated work environment, building partnerships and modeling teamwork, and communicating to the team in an open, balanced and objective manner.
- Summarizes and presents results to supervisor in a logical manner, verbally and in written reports or presentations. May present data to project team meetings.
- Works closely with SAS programmer and Clinical Operations to ensure deliverables are completed in a time-efficient manner.
- PhD or equivalent in Pharmacology, Biomedicine, Biochemistry or related scientific discipline with a minimum 3-5 years of relevant experience within a pharmaceutical industry, contract research, or clinical research.
- Solid PK training and experience is a must.
- Proficiency with using Phoenix Winnonlin for non-compartmental analysis is a must.
- Demonstrated experience with diverse PK, ADA and NAb bioanalytical methods, including development, validation, and sample analysis.
- Familiarity with reagent/sample management is desirable.
- Experience collaborating with bioanalytical CROs.
- Experience with clinical development of therapeutic molecules is highly desirable.
- Hands on clinical pharmacology related work experience in regulatory and scientific documentation writing including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports, as well as regulatory documents.
- Advanced spreadsheet skills are desirable.
- Exceptional analytical and problem-solving capabilities.
- Effective interpersonal, written and verbal communication skills.
- Strong clinical/scientific writing skills.
- Ability to manage multiple projects, prioritize work, and meet deadlines.
- Capable of anticipating and recognizing potential problems within project plans and effectively communicating alternatives.
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
- 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
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Senior Scientist, Clinical Pharmacology - Vancouver, Canada - Zymeworks
Description
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 Vancouver office and is hybrid with a minimum of 3 days per week onsite.
Key Responsibilities
Education and Experience
Skills and Abilities:
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 Canadian base salary range for this full time position is $109,000 - $167,000 + 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 Canadian 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 role postings reflect the base salary only, and do not include bonus, equity, or benefits.
Our team enjoys:
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.