Sr./Medical Director, Clinical Development

Clinical · Seattle, Washington
Department Clinical
Employment Type Full-Time
Minimum Experience Experienced

Chinook Therapeutics is a biotechnology company developing precision medicines for patients with kidney diseases.  We apply our proprietary research platform to discover and develop therapeutics with novel mechanisms of action against key kidney disease pathways.  Our development focus is on rare, serious disorders with clear unmet medical needs and with defined and rapid clinical development opportunities.  Chinook recently in-licensed a late-stage product, atrasentan, and plans to initiate a phase 3 trial for chronic kidney disease during 2020.  Our pipeline has several other internal programs at the validation and lead optimization stages, the first of which is rapidly progressing to enter clinical trials by 2021.  We are also evaluating business development opportunities for early and late-stage clinical assets to enhance the pipeline.

Chinook has raised a $65 million Series A financing from top tier venture capital firms Versant Ventures, Apple Tree Partners, and Samsara BioCapital.  We are a growing team of approximately 30 employees and are based in Vancouver, British Columbia and Seattle, Washington.

 

Position:

The Medical Director/Sr. Medical Director, Clinical Development will be responsible for the clinical leadership and execution of the atrasentan development program from phase 3 design, global regulatory interactions, study conduct, medical monitoring, and be a strong contributor to the statistical analysis plan. This role will partner with clinical operations, biometrics, regulatory affairs, quality assurance, pharmacovigilance, and medical affairs in order to produce high quality pivotal trial results that support successful global registrations and launch. The position will be based in Seattle, Washington or Vancouver, BC, report to the Chief Medical Officer, and be a key member of the clinical development leadership team.

 

Responsibilities include:

• Serving as the company’s clinical resource for renal diseases as well as previous and ongoing atrasentan clinical trial data

• Developing a clinical and regulatory strategy for the company’s lead late-stage asset and executing upon a global development plan, including a pivotal trial planned to start in 2020

• Overseeing all medical monitoring activities

• Serving as the medical officer accountable for ensuring appropriate precautions are taken to minimize risk to patients participating in atrasentan clinical studies and updating key documents as new safety information becomes available

• Developing and maintaining strong medical relationships with all external constituents and consultants, including thought leaders, clinical trial investigators, academic centers, community-based trials consortia and advocacy groups

• Ensuring that clinical development programs are compliant and conducted in accordance with applicable regulatory requirements and guidelines

• Ensuring that all clinical and medical activities are in keeping with approved timelines and budgets, with proactive risk identification and mitigation

• Working with the Chief Medical Officer, Chief Business Officer and other key executives on business development and alliance management issues which can leverage the company’s scientific expertise

• Contributing to the development and maintenance of a positive team-focused company culture

 

Education, Experience, and Skills:

• M.D. clinical executive with at least 8 years of pharmaceutical and/or biotechnology industry experience – expertise in nephrology and/or rare drug development is preferred 

• Strong leadership skills to translate corporate objectives into action plans that effectively and consistently deliver high quality data on time and on budget

• Experience in the execution of complex international late stage development programs 

• Experience in the development of key regulatory submissions including NDAs, BLAs, MAAs, and INDs as well as interacting with regulatory authorities and supporting site/sponsor regulatory inspections 

• Skilled at critically evaluating business development opportunities from the clinical perspective 

• Thorough understanding of GCP and ICH Guidelines governing the conduct of clinical trials, good working knowledge of FDA and EMA regulations and expertise in the execution of clinical trials, particularly those relating to rare disease settings

• Solution-oriented, with a demonstrable track record of identifying and solving difficult clinical development challenges in a competitive clinical trial landscape

• Team player with executive presence and demeanor, excellent written and verbal communication skills, and outstanding analytical abilities

• Ability to adapt quickly to changing environments and priorities 

• Positive attitude and high personal and ethical standards in achieving corporate goals

 

Chinook is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground. 

 

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  • Location
    Seattle, Washington
  • Department
    Clinical
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced