Head of Clinical Assays and Biomarkers

Company: Nomis Solutions
Location: Cambridge
Posted on: February 25, 2021

Job Description:

Beam is seeking a Clinical Assays and Biomarker Director to develop and drive biomarker strategy across our portfolio of next-generation gene editing therapies, working collaboratively with cross functional team members. The role will involve the establishment and management of a clinical assays and biomarkers team, which will liaise with external assay laboratories, collaboration partners and CROs. This position will work across several disease/program teams and associated compounds to ensure planning, execution and data delivery of the biomarker strategy plans and data for all clinical trials conducted by Beam. Additionally, the role will encompass the management of a team of direct and indirect reports. Responsibilities:

• With input from the research and clinical leads, evaluate technologies to identify, define and implement the biomarker strategy to support the clinical development of Beam's compounds
• Drive the biomarker strategy to ensure assay labs complete appropriate qualification or validation work in order to execute on the clinical biomarker plan(s) on time and with appropriate quality standards
• Ensure the timely and efficient delivery of all biomarker operational aspects across therapeutic area clinical trials
• Accountable for planning, coordinating, and overseeing all operational activities required to manage the flow of biomarker samples from planning, collection, analysis, data delivery and final sample disposition
• Serve as a single point of contact for biomarker operations across teams, and with collaborators, assay labs and CROs.
• Responsible for the identification and selection of biomarker vendors in collaboration with the Translational Science/Research leads
• Ensure collection, delivery and analysis of biosamples according to the protocol and in compliance with protocol, informed consent, local regulations as well as GCP/ICH
• Develops and provides operational input and recommendations into all study related documentation (including protocol, informed consent form, and amendments) and processes.
• Manage development and oversight of the biomarker analysis timelines, with respect to the budget, risk and quality plans--
• Attend operational team meetings, monitor trainings, CRO kick-off--meetings, etc., to deliver insight and trainings on biomarker activities to appropriate parties--
• Contributes to biomarkers data interpretation and reporting. Qualifications:
  • MD/Ph.D. or equivalent with minimum of 5 years or MA/MS with minimum 8 years of relevant experience in pharmaceutical industry setting in the application of biomarkers in clinical trials, preferably in Hematology, Oncology or Rare Diseases of the liver.
  • Proven track record of high-impact contributions to biomarker discovery and assay development
  • Experience in clinical translational or biomarker work and its role across drug development from early phase through licensure--
  • Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms
  • Knowledge and track-record of working to GCP principles
  • Strong sense of urgency and ability to thrive in a fast-paced, matrix environment
  • Excellent prioritization, planning and interpersonal skills
  • Experience in managing contract laboratories and budgets
  • Demonstrated scientific capability as evidenced by publications, research reports, and external presentations.
  • Effective verbal and written communication skills U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Beam Therapeutics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. Gender Please select Are you Hispanic/Latino? Please select Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Please select Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
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Keywords: Nomis Solutions, Cambridge , Head of Clinical Assays and Biomarkers, Healthcare , Cambridge, Massachusetts