Associate Director/Director, Clinical Science

Seattle, WA, United States

Associate Director/Director, Clinical Science

Our Company

Presage Biosciences is an oncology company pioneering a new drug development approach to assess novel therapeutics and combinations directly in human tumors. In a Phase 0 clinical trial, our Clinical In Vivo Oncology (CIVO) platform determines the complexity of drug response by microdosing investigational drugs directly within a patient’s tumor.

The Role

The Associate Director/Director, Clinical Science provides leadership in the areas of development and execution of analytical plans for CIVO clinical study protocols, external clinical partner relationship management, and working with cross-functional teams to shape the company’s alliances and CIVO clinical program strategy. This individual works in tandem with Clinical Operations.

Key Responsibilities

• Lead cross-functional communication for the CIVO Program tracking inputs, actions, and deliverables across internal functions and with partners including managing/communicating timelines, stakeholder management, partner outreach, risk management , and interim/final clinical study reports;

• Provide scientific input and review of all translational medicine aspects of clinical and regulatory documents, including, but not limited to development plans, study protocols, clinical study reports, regulatory submissions, and responses to regulatory questions;

• Direct workflow, interpret findings, and synthesize conclusions based on observed responses to drug(s) in the tumor microenvironment working in tandem with Research, Clinical, Histology, Image Analysis, and Bioinformatics collaborators;

• Collaborate with research and clinical operations teams to develop biomarker and data analysis strategies that assess proof of mechanism, establish early signs of efficacy, enable proof of concept studies, and enable patient selection/generation of understanding of the variability in patient response for internal and/or partnered CIVO clinical studies;

• Attend and present at leadership meetings, internal meetings, and conferences on an as-needed basis; may include content creation for analytical reporting, abstracts/manuscripts, and data presentations;

• Initiate, support, and manage the company’s clinical study publication strategy in peer-reviewed scientific journals.

Qualifications

Education

· Extensive background and experience in Biology, Molecular Biology, Cellular Biology, Immunology, or Cancer Biology. PhD preferred.

Work Experience

· Minimum 5 years’ related experience in the biotech/pharmaceutical industry or an equivalent combination of education and experience (e.g., postdoctoral fellowship, academic research scientist position).

· Experience developing and leading preclinical and/or clinical translational studies.

Additional Qualifications

· Ability to drive and influence projects from discovery through early clinical development;

· Outstanding project management, analytical, and organizational skills with the ability to manage concurrent deliverables and competing priorities in a self-directed manner;

· Familiarity with medical terminology/medicine is advantageous in this role;

· Familiarity with data analysis tools and complex genomic data sets;

· Familiarity with regulatory submissions or FDA interactions a plus;

· High energy and strong interpersonal skills;

· Ability to effectively collaborate with internal and external stakeholders;

· Results oriented with excellent attention to detail;

· Strong oral and written communication skills and the ability to present effectively and professional to internal and external audiences;

· Ability to prioritize and be highly productive and flexible in a fast-paced work environment;

Work Environment

Hybrid remote/onsite arrangements available. Occasional travel may be required.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to sit or stand for extended periods of time.

Salary Range

The salary range is $100,000-$150,000. Well-qualified candidates are anticipated to fit within this range with most candidates anticipated to come in at the midpoint of the range. This will depend on qualifications, experience, and career level of the individual.

Benefits

401(k)

401(k) matching

Dental insurance

Flexible spending account

Health insurance

Health savings account

Life insurance

Paid time off

Vision insurance

Join Us!

If you enjoy a stimulating office environment, are based in the Seattle area, and most importantly, have a passion for improving the lives of patients with cancer, come join us!

To apply for this position, please send your CV with cover letter to:

Presage Biosciences, Inc.

Attn: Human Resources

530 Fairview Ave N, Suite 1000

Seattle, WA 98109

E-mail: [email protected]

Presage Biosciences, Inc. is an Equal Opportunity Employer.

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