Full description
At [Company], we’re Powering the Age of Immune Medicine. Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated.
As an Adapter, you’ll have the opportunity to make a difference in people’s lives. With [Company], you’ll create a career highlight through collaboration with bright, curious colleagues working at the apex of innovation and application.
It’s time for your next chapter. Discover your story with [Company].
Position Overview
The Sr Director, Clinical Product Development will manage a scientific, bioinformatics, and software algorithm development teams which is responsible for the development of [Company] clinical assays and products. This role also supports Real World Data generation and software algorithm development to enhance capabilities for the clinical lab and manufacturing.
Leaders at [Company] demonstrate behaviors consistent with [Company]’s Core Values and Leadership Principles. Critical functions of your role include helping establish individual team member goals, aligning those individual goals with broader team objectives, and ensuring those objectives drive the achievement of company goals. Providing thoughtful coaching and consistent feedback to your team members will drive performance excellence and accountability, as well as support your team members’ growth and development. Leaders at [Company] create an environment of belonging, respect, and open and honest communication every day.
Key Responsibilities and Essential Functions
- Responsible for managing a team that is responsible for clinical product development activities, which could include technical feasibility, methods development, assay development, design risk management, bioinformatics and software algorithm development, verification and validation (V&V) studies, new indications, support IST data generation, and serve as the technical representative in customer facing meetings for MRD business.
- Collaborate with other departments, including Research, Technical Operations, Medical Affairs, Software, PMO, Integrated Supply Chain, Quality & Regulatory, Clinical Lab Director, Legal, Finance, Equipment Engineering, and Commercial to achieve the goal of developing assay prototypes to commercial products.
- Communicates plans, proposes short- and long-term strategies, timelines, and results to executive level and with stakeholders across the organization.
- Guides decision-making and scientific mentorship
- Manages team members performance and career development
- Seen as [Company]’s SME regarding product development work, which includes strong understanding and contributes to results analysis of NGS immunosequencing data and complex statistical analyses.
- Write and edit study reports, with analysis support from technical experts from the larger team.
- All other duties as assigned.
Position Requirements (Education, Experience, Other)
Required
- PhD (or advanced degree) in molecular genetics, immunology, bioengineering or related field
- 10+ years of experience in a diagnostic, medical device or life sciences company
- Experience managing subordinate managers
Preferred
- Minimum of 5 years of Product Development Process (PDP) experience with regulated IVD product development under design control, including verification and validation activities; prior experience with NGS diagnostic product commercialization strongly preferred.
- Demonstrated experience in ISO, CLIA, CAP, CLEP, FDA, IVDR, GxP or equivalent regulatory compliance requirements required.
- Familiarity with the application of basic statistical analyses required.
- Excellent technical scientific writing, communication, and organizational skills, with significant attention to detail.
- Experience in hematology, oncology, immunology with NGS technology is preferred.
- Prior experience with JMP, R or other statistical analysis software preferred.
Working Conditions
Must also have flexibility and willingness to work more than standard hours when necessary, including nights & weekends, etc. Travel to Corporate, conferences, and customer meetings as necessary.
Compensation
Salary Range: $206,400 - $309,600
Possible “other compensation” elements to include:
- equity grant
- bonus eligible
ALERT: Malicious groups posing as [Company] employees have recently used fraudulent email aliases to extend employment offers, provide fake documents, and request sensitive personal and financial information. Legitimate [Company] employment opportunities are initiated through our careers page and extended after multiple interviews with verified employees. [Company] does not ask new hires to purchase anything out-of-pocket, including home office supplies and equipment.
Interested in this position, but don’t meet all the requirements? [Company] is committed to building diverse, equitable, and inclusive teams across our organization. Please consider applying even if your experience doesn’t match all the qualifications; you may be the exact candidate we’re searching for!
[Company] is not currently sponsoring candidates requiring work authorization support for this position.
[Company]’s posted compensation information includes a base salary (or hourly rate) range and summary of other available total compensation. The base salary range represents a minimum-to-maximum salary (or hourly rate) available to candidates upon extension of offer. Base salary is thoughtfully considered upon offer and is determined through multiple evaluation checks throughout the interview process, including: a candidate’s ability to meet minimum qualifications (skills/experience/education), a candidate’s ability to thoughtfully address preferred qualifications, current market conditions, and internal pay equity. Listed base salary is exclusive of bonus, commission, equity, differential pay, benefits, and other incentives.
[Company]’s benefits at-a-glance.
[Company] is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. Please refer the “Know Your Rights: Workplace Discrimination is Illegal” Poster for more information. If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email hr@adaptivebiotech.com.
If you have a disability and you believe you need a reasonable accommodation to search for a job opening or to submit an online application, please e-mail accommodations@adaptivebiotech.com. This email is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.
NOTE TO EMPLOYMENT AGENCIES: [Company] values our relationships with our Recruitment Partners and will only accept resumes from those partners who have active agreements with [Company]. [Company] is not responsible for any fees related to resumes that are unsolicited or are received by any employee of [Company] who is not a member of the Human Resources team.
Originally posted on Himalayas