Director/Sr. Director Clinical Development/Science at ArcherDX

| Greater Boulder Area | Remote
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Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.
 
POSITION SUMMARY:
The Clinical Science Lead/Director is a critical member of the Oncology Diagnostics.  They will be responsible for clinical strategy at the project level and provide clinical expertise in diagnostic product development, clinical trial design and regulatory submissions.  The successful candidate must possess a thorough understanding of the oncology diagnostic and therapeutic spectrum as they relate to clinical biomarker development, regulated product development, the oncology therapeutic landscape, and the regulatory guidelines for diagnostic submissions.  They will have the ability to identify and define critical test attributes that affect conduct of clinical research and potential impact on overall product design.  A collaborative approach is essential for this leader as they will interface and work in partnership with multiple cross-functional teams across different locations in support of programs pivotal to ArcherDX. 
RESPONSIBILITIES:
Job performance will involve a variety of activities including:
  • Work with the Oncology Diagnostic teams to design, implement, interpret, report and publish clinical studies for regulatory applications.
  • Assist Product Development with clinical implications of assay design, design of performance verification, analytical study design and assay and instrument readiness for clinical trials
  • Provide medical/scientific input into and assists with the preparation of regulatory submissions. Prepare and provide responses to clinical questions or requests from regulatory agencies
  • Provide clinical expertise and leadership to Clinical Operations, Data Management, Biostatistics, Medical Affairs, Regulatory Affairs, Quality/Design Assurance, Product Development and Product Management groups
  • Identifies and defines critical clinical test attributes that affect the conduct of clinical research and potential impact on overall product design and lifecycle
  • Explore and define potential clinical utility for company products and clinical bridging strategies for Clinical Trial Assays
  • Chairs Investigator Initiated Trial Committee overseeing external academic partnership projects ensuring clinical utility and product development needs are addressed
  • Provide medical opinions and analysis of product safety.
  • Assist Medical Affairs in guidance to the Product Management teams to ensure marketing and promotional materials are both scientifically accurate and medically sound
  • Review publications by ArcherDX and external collaborators for scientific and medical content
  • Serve as a clinical sciences expert at ArcherDX, keeping the company abreast of advances in relevant precision medicine and health systems, as they relate to Oncology Diagnostics
  • Over time, develop and retain highly skilled and effective Clinical Science team to support ongoing programs and future development opportunities
  • Strategically partner across ArcherDX on the design and execution of robust clinical strategy
  • Authors and reviews standard operating procedures and adheres to ArcherDX quality standards
  • Effectively communicate and discuss complex diagnostic clinical science and IVD development issues with project teams, upper leadership and external partners
  • Safeguarding the privacy and security of protected health information and European Union personal data
  • Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology
  • Provide insight to pipeline determination in clinical feasibility, and translate findings from research and nonclinical studies into clinical development opportunities
  • Contribute relevant clinical sections to documents such as the Investigator Brochures, Significant Risk Determination or Investigational Device Exemption
  • Responsible for analyzing clinical data, drafting reports, abstracts, posters, CSRs and presentations on the various findings of the clinical research
  • Position can be remote for the right candidate.
EDUCATION:
  • PhD in biological sciences, MD or MD/PhD with specialization in oncology and/or molecular pathology
EXPERIENCE:
  • Minimum of 5 years (preferably 10+) of Clinical Science and Clinical Development experience in the oncology diagnostics and therapeutics
  • Broad understanding of Oncology diagnostics and treatment landscape
  • Up to date knowledge of novel NGS technologies and their application in Oncology diagnostics
  • Experience in diagnostic, drug and CDx co-development trials
  • Deep understanding of the CDx development process and regulatory landscape
  • Working knowledge of GCP, GLP and federal and local regulations
  • Proven clinical development strategist with experience designing, implementing and conducting diagnostic clinical trials
  • Extensive strategic leadership and communication skills with strong initiative, ethics, and judgment, and demonstrated ability to positively represent the goals of the organization
  • Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators
  • Possess an understanding of applicable US and EU drug development regulations and GCP regulations
  • Proven ability to manage timelines and adhere to budgetary requirements
  • Experience in interfacing with and presenting to executive leadership and external partners
  • Experience building effective teams and managing conflict
  • Effective at attracting, developing and retaining talented team members.
  • Willing to lead, act as a player-coach and roll up his/her sleeves and do what is necessary to meet project and corporate goals
  • Excellent verbal and written communication and presentation skills Excellent project management skills
KEY ATTRIBUTES:
  • Drive and determination
  • Ability to work in a fast paced and dynamic environment
  • Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects
  • Ability to build strong relationships within all parts of the company. Strong communication and presentation skills
  • Driven to perform
  • Self-directed: needs little explicit direction
  • Able to organize, prioritize, and delegate tasks to efficiently move projects forward.

Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:
Health, dental, vision, short- and long-term disability, and basic life insurance coverage
Paid time off, holiday pay, parental leave, and other health and wellness supports

In Colorado, our competitive compensation package includes a base salary starting from $175,000.  In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.

At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.

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Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • PostgreSQLDatabases

Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

An Insider's view of ArcherDX

What’s the vibe like in the office?

Collaborative - when I walk through the ArcherDX office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Archer. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

What are ArcherDX Perks + Benefits

ArcherDX Benefits Overview

ArcherDX offers a competitive and generous benefit package including:

• Medical PPO or HMO and Dental-82% of monthly premium covered by the company
• Optional vision, life, FSA, dependent care plans
• Basic AD&D, Short and Long Term disability-covered 100% by the company
• 160 hours PTO per calendar after three months of service
• 6-weeks parental leave covered 100% by the company
• 401K with company match with potential of up to $2000/year
• 2019 bonus - 5% based on company objectives (for non-commissioned employees)
• Company stock options for all employees
• Tuition Reimbursement
• Ecopass

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Diversity
Documented equal pay policy
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Company sponsored family events
Archer sponsors family oriented events annually. This year, we had our summer picnic at the Boulder Reservoir.
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Cross functional training encouraged
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