- Provides medical/scientific, strategic and operational expertise and support for the planning and execution of IND filings and early stage clinical trials.
- Provides expert opinion on the pathophysiology and diagnosis of disease, existing and emerging treatments and unmet medical needs to inform key medical and business decisions.
- Conducts medical monitoring of clinical trials; writes protocols, informed consent documents; responds to questions from regulatory agencies, institutional review boards and ethics committees; reviews clinical data, case report forms and ensures final accuracy of clinical trial data for clinical study reports.
- Conducts safety monitoring, oversees conduct of clinical sites for adherence to both company standards, and government/industry regulations (GCP/ICH); supports development of investigator brochures; trains investigators and travels to clinical sites to build relationships with investigators and study teams in support of study enrollment.
- Institutes and continuously improves operating procedures ensuring best practices.
- Establishes appropriate strategic partnerships with centers of excellence, advocacy groups and KOLs in the areas of scientific interest.
- Collaborates closely with key stakeholders to ensure tight strategic integration of product development plans and strategies. Plans and develops content for advisory meetings with opinion leaders and for medical symposia.
- Participates in review of medical materials to ensure content is medically appropriate and compliant with internal and external requirements.
- Oversight of partnered clinical research operations (CRO) vendors.
- Keeps up to date on current relevant therapeutic areas through familiarity with literature, attendance at meetings, conventions and professional associations.
- MD or equivalent, with a minimum of 3-5 years of biotech or pharmaceutical experience in oncology drug development. Oncology fellowship training and ABIM Oncology certification preferred.
- 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 and the ability to lead through example.
- Strong understanding of clinical trials process with demonstrated ability to have designed and implemented programs and initiatives directed towards defined strategic objectives.
- Early stage development and regulatory experience preferable.
- Excellent organizational skills with the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
- Strong problem-solving skills with the ability to think and act strategically, anticipate roadblocks and map out next steps.
- Demonstrated high level of integrity, ethics and professionalism.
- Knowledge of scientific methods, research design and medical practices and procedures.
- Excellent writing and oral presentation skills. Demonstrated ability to communicate scientific results.
- Ability to travel.
- 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
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Medical Director, Early Stage Clinical Development - San Francisco, United States - Zymeworks Inc.
Description
Company DescriptionZymeworks 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 UsNothing 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.
This role will be based out of our San Francisco office and is hybrid with a minimum of 3 days per week onsite.
Reporting into the Vice-President Early-Stage Development Americas, the Medical Director, Early Stage Clinical Development:
We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth.
The US base salary range for this full-time position is $214,000 - $328,000 + 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.
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 7, 2024
