Head of Companion Diagnostics & Regulatory Strategy

Precision Medicine Group; Frederick (MD); On-site; USD 203,000 - 305,000; Full time

Benefits offered by this job

Health insurance

Retirement savings benefits

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group in Frederick, MD seeks a Senior Director, Companion Diagnostics to oversee laboratory activities supporting both commercial CDx analyses and development programs. The role requires deep knowledge of FDA guidance and experience translating it into robust, pass-ready assays.

You will lead design, validation, and CLSI/CLIA/CAP compliant operations, mentor staff, monitor KPIs, coordinate audits, and collaborate with QA, Regulatory and project teams to ensure timely client

Qualifications

• PhD in Immunology or related field.
• 18+ years’ relevant experience.
• 12+ years' leadership experience.
• Prior supervisory experience.
• Expertise in Companion Diagnostics related to Cell & Gene Therapy regulatory guidance and industry best practice.
• Direct experience and knowledge in cell based assays used for supporting regulated studies.
• Solid understanding of current GLP, GCP or GCLP standards.
• Working knowledge of CAP/CLIA, CLSI and ISO 13485.
• Excellent communication, interpersonal, organizational and multi-tasking skills.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Ability to work independently and have good attention to detail.
• Must be able to read, write, speak fluently and comprehend the English language.

Responsibilities

• Mentor and lead all companion diagnostic teams to ensure high quality compliant data.
• Works with Lab Director to identify and provide continuing education to laboratory testing personnel that is relevant to laboratory practices.
• Direct staff to ensure consistent scientific standards and compliance with Precision procedures and regulatory expectations on all projects.
• Monitors and provides metrics, KPIs to senior leadership which includes but is not limited to: quality metrics, TAT, assay failure rate, volumes and revenue.
• Monitors inventory and lab supplies; ensures staff perform regular inventory counts and updates the inventory software system.
• Ensure lab is run efficiently, reviews processes, SOPs and implements improvements regarding operational excellence.
• Is main contact for clients regarding scientific updates and manage client expectations for all projects within the team.
• Participate actively in the companion diagnostics community to ensure Precision is fully aware of any and all relevant guidance with the Cell & Gene Therapy Industry.
• Participate in product development, commercialization and life cycle management.
• Have good working knowledge of execution of assay according to ISO 13485 Design Control procedures, ISO 15189 Medical Laboratories as well as knowledge of CLIA and CLSI requirements for assay validation.
• Coordinate cross-functional activities to increase operational efficiencies and streamline deliverables to clients.
• Review and approve development and validation study protocols and reports to meet CAP/CLIA and CLSI requirements.
• Oversee the execution of all work to ensure study compliance including budget requirements.
• Responsible for trouble shooting and correcting all scientific issues/problems within the team.
• Prepare/review/write critical documents including protocols, reports, and SOPs.
• Work collaboratively with other technical teams in resource sharing and providing technical expertise.
• Maintain and support safe lab practices and environment.
• Carry out other duties/projects as assigned.

Skills

Leadership

Regulatory compliance

CDx expertise

Education

PhD in Immunology or related field

Job description

The Senior Director, Companion Diagnostics (sitting onsite in Frederick, MD) will be responsible for overseeing the laboratory activities for teams focused on supporting both commercially approved CDx sample analysis as well as CDx programs in development. They will use their scientific expertise to lead design, development and validation efforts for cell therapy assays to support multiple fast-paced clinical and non-clinical studies for clients engaged in cutting-edge research. A critical requirement is deep current knowledge of FDA guidance documents and requirements, specifically relevant to companion diagnostics, along with the ability to put these requirements into practice developing robust assays that easily pass FDA scrutiny. Experience with developing and managing programs following FDA. ISO 13485 and 15189 principles of design control, understanding of both CLIA and CLSI validation requirements, and assay execution of both cell-based and non-cell-based assays is required.

As the Senior Director, Companion Diagnostic, this person will train and mentor staff to ensure scientific rigor and regulatory compliance to GxP, CLSI, CLIA/CAP and State DOH (eg.,NY, CA, RI, PA) use their expertise to guide assay development and troubleshooting. The position requires direct experience in all aspects of companion diagnostics, large molecule regulated bioanalysis and working knowledge of industry best practices. The person will work closely with QA and Regulatory to ensure regulatory compliance and work with project managers to ensure laboratory delivery and timely and efficient client communication. Lastly, the ideal candidate will have had experience with hosting and/ or participating in regulatory audits.

Essential functions of the job include but are not limited to:

• Mentor and lead all companion diagnostic teams to ensure high quality compliant data.
• Works with Lab Director to identify and provide continuing education to laboratory testing personnel that is relevant to laboratory practices
• Direct staff to ensure consistent scientific standards and compliance with Precision procedures and regulatory expectations on all projects
• Monitors and provides metrics, KPIs to senior leadership which includes but is not limited to: quality metrics, TAT, assay failure rate, volumes and revenue.
• Monitors inventory (client and precision inventory) and lab supplies; ensures staff perform regular inventory counts and updates the inventory software system.
• Ensure lab is run efficiently, reviews processes, SOPs and implements improvements regarding operational excellence.
• Is main contact for clients regarding scientific updates and manage client expectations for all projects within the team. Provides verbal or written updates as necessary.
• Participate actively in the companion diagnostics community to ensure Precision is fully aware of any and all relevant guidance with the Cell & Gene Therapy Industry
• Participate in product (device) development, commercialization and life cycle management
• Have good working knowledge of execution of assay according to ISO 13485 Design Control procedures, ISO 15189 Medical Laboratories as well as knowledge of CLIA and CLSI requirements for assay validation. Coordination of cross functional activities between Precision business units and among various subject matter experts to increase operational efficiencies and streamline deliverables to clients
• Review and approve development and validation study protocols and reports to meet CAP/CLIA and CLSI requirements
• Oversee the execution of all work to ensure the team understands and is meeting study compliance for all work performed, including study budget requirements.
• Responsible for trouble shooting and correcting all scientific issues/problems within the team
• Prepare/review/writes critical documents including protocols, reports, and SOPs
• Work collaboratively with other technical teams in resource sharing and providing technical expertise
• Maintain and support safe lab practices and environment
• Carry out other duties/projects as assigned

Qualifications:

• PhD in Immunology or related field
• 18+ years’ relevant experience
• 12+ years' leadership experience

Other Required:

• Prior supervisory experience
• Must have demonstrated expertise in Companion Diagnostics related to Cell & Gene Therapy regulatory guidance and industry best practice
• Direct experience and knowledge in cell based assays used for supporting regulated studies
• A solid understanding of current GLP, GCP or GCLP standards
• Working knowledge of CAP/CLIA, CLSI and ISO 13485
• Excellent communication, interpersonal, organizational and multi-tasking skills
• Must be proficient with Microsoft Word, Excel, and PowerPoint
• Ability to interact and function in a highly productive work environment
• Ability to work independently and have good attention to detail
• Must be able to read, write, speak fluently and comprehend the English language

Preferred:

• Direct experience working at a CRO, Biotechnology or Pharmaceutical company.
• Expertise in ELISA, MSD, Luminex, Quanterix and SPR technologies

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$203,200 - $304,800 USD

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