What are the responsibilities and job description for the Consultative Medical Director position at Charles River Labs?

For over 40 years, Charles River Cell Solutions has worked to making a positive impact on the world by providing the highest quality cellular material and services to biotech and pharmaceutical companies and research organizations that are performing innovative research and developing novel cell-based therapies.

We recognize that our success depends on the vision and passion of our employees; that is why we are devoted to making Cell Solutions a rewarding and valuable place to work. We believe in making a difference, and at Cell Solutions, you will make a difference every day.

Job Summary

The Consultative Medical Director (CM) is engaged for expertise in donor selection and blood product collection operations at Charles River Laboratories Cell Solution donor center. The CM will also engage collaboratively with the commercial team as indicated by customer needs and with QA / RA to assure entity’s adherence to applicable Local, State and Federal regulations and guidelines. This position reports directly to the Executive Director, Global Cell Solutions.

Essential Responsibilities

Donor Recruitment / Donor Room / CLIA Lab consultation

Analysis of donor records and collection history to ascertain donor’s qualification or continued participation in IRB-approved protocols or for particular customer needs. Determinations will be communicated to appropriate Donor Room / Donor Recruitment personnel.
Analysis of lab reports including CBCs and flow cytometry on donors, both healthy and disease state to look at product quality.
On-call coverage for the on-site medical director with 24-hour availability M-Thurs for emergent need or planned time off :
Review of donor chart and lab reports as indicated
CLIA related laboratory director responsibilities.
Provide final eligibility
Provide consultation for donor and lab issues

Business and Client Relations

Be available for occasional 30 to 60 min. calls with commercial / client service team members and customer. Allows for clarity of requests and feasibility of proposed project.

Familiar with all key medical, technical and administrative personnel in the field, including organizational and reporting structures.

May be called upon to be present at opening / closing remarks of a customer led audit of the CRLCS facility.

Quality, Education and Training Programs

Must be familiar with company SOPs and Safety Manual, Good Tissue Practices (GTPs), current Good Manufacturing Practices (cGMPs) as applied to cell therapy products, and FDA guidance documents, USP chapters, and AABB standards relevant to cell therapy.

May be called upon to analyze or review quality assurance activities and reports, including incident reports.

May be called upon to analyze program for compliance with rules and guidance set by US Food and Drug Administration rules and guidance or other accreditation or regulatory organizations.

May be asked to collaborate with QA on revisions or composition of : relevant standard operating procedures / policies, study protocols and informed consents.

Job Qualifications

To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Discretion in handling confidential and sensitive matters

Able to write / orally present scientific material.

Education, Experience, and Licensure

CA MD licensure

Technical Skills

Proficient use of Microsoft Office products, including Word, Excel, Outlook, and PowerPoint.

Ability to quickly learn new software programs as needed.

Compensation Data

The pay range for this position is $124.95 - $154.33 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

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Salary : $125 - $154

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