Cellectis
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Manager, Biomarker Operations
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Cellectis 4 weeks ago Be among the first 25 applicants Join to apply for the
Manager, Biomarker Operations
role at
Cellectis Get AI-powered advice on this job and more exclusive features. Job Description
Title
Manager, Biomarker Operations
Reports to
SVP, Immuno-Oncology and Transitional Science
Location
New York, NY
Purpose And Responsibilities
The successful candidate will
(Responsibilities include, but are not limited to):
Develop and maintain effective, collaborative relationships with Clinical Study Teams, Clinical Sites, CROs, and other key stakeholders to ensure biomarker samples are, processed, tested and data is reported to meet development timelines and specifications Establish study-specific biomarker analysis and data management plan Manage the execution of biosample analysis logistics and timelines, from sample collection and processing, shipment, testing, data transfer, and final sample disposition, in accordance to study protocol and under the highest standards of quality, ethics, and informed consent Proactively identify, resolve, and facilitate resolution of sample and data discrepancies. Provide biosample metrics and status updates to teams as requested. Contribute to Central Lab setup and management throughout the course of a study Collaborate on the development and finalization of the Biomarker Management Plan based on input from Translational and Clinical Operational teams Contribute to the preparation of clinical documents such as lab manuals, informed consent forms, sample management plan, early development plans and site training materials Develop and maintain biomarker data standards and processes to ensure consistency across clinical trials
Education And Experience
PhD with 2+ years project management, oncology and/or clinical trial experience or Master’s Degree with 3+ years project management, oncology and/or clinical trial experience or Bachelor’s Degree with 7+ years of project management, oncology and/or clinical trial experience Demonstrated technical experience/knowledge of bioanalytical assay methods related to cancer immunotherapy, T cell engagers, and antibody-based therapeutics is preferred. Experience with clinical study operations teams and understanding of clinical drug development strategic planning of clinical research; working knowledge of ICF, ICH GCP, GLP, regulatory compliance and FDA standards. Proven ability to efficiently and effectively manage multiple competing priorities and deliver results successfully. Proven success leading teams, working collaboratively in a cross-functional environment, and motivating team members to drive toward success Final level based on qualifications and experience Role is based in New York and hybrid (4 days/week in office)
Technical Skills / Core Competencies
Is a team player who is able to participate in collaborative, cross-functional projects while being adept in working efficiently as an individual Strong analytical and problem-solving skills Excellent communication and interpersonal skills Strong project management and organizational skills Excellent troubleshooting and multi-tasking skills, attention to detail Ability to effectively and collaboratively work on global cross-functional teams Comfortable operating in a fast-paced environment and able to multi-task and adjust workload based upon changing priorities
Physical Requirements
Sedentary - primarily involves sitting and/or standing. Communicates with others on a daily basis to exchange information. 4 days per week onsite required
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Management and Manufacturing Referrals increase your chances of interviewing at Cellectis by 2x Get notified about new Operations Manager jobs in
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Manager, Biomarker Operations
role at
Cellectis 4 weeks ago Be among the first 25 applicants Join to apply for the
Manager, Biomarker Operations
role at
Cellectis Get AI-powered advice on this job and more exclusive features. Job Description
Title
Manager, Biomarker Operations
Reports to
SVP, Immuno-Oncology and Transitional Science
Location
New York, NY
Purpose And Responsibilities
The successful candidate will
(Responsibilities include, but are not limited to):
Develop and maintain effective, collaborative relationships with Clinical Study Teams, Clinical Sites, CROs, and other key stakeholders to ensure biomarker samples are, processed, tested and data is reported to meet development timelines and specifications Establish study-specific biomarker analysis and data management plan Manage the execution of biosample analysis logistics and timelines, from sample collection and processing, shipment, testing, data transfer, and final sample disposition, in accordance to study protocol and under the highest standards of quality, ethics, and informed consent Proactively identify, resolve, and facilitate resolution of sample and data discrepancies. Provide biosample metrics and status updates to teams as requested. Contribute to Central Lab setup and management throughout the course of a study Collaborate on the development and finalization of the Biomarker Management Plan based on input from Translational and Clinical Operational teams Contribute to the preparation of clinical documents such as lab manuals, informed consent forms, sample management plan, early development plans and site training materials Develop and maintain biomarker data standards and processes to ensure consistency across clinical trials
Education And Experience
PhD with 2+ years project management, oncology and/or clinical trial experience or Master’s Degree with 3+ years project management, oncology and/or clinical trial experience or Bachelor’s Degree with 7+ years of project management, oncology and/or clinical trial experience Demonstrated technical experience/knowledge of bioanalytical assay methods related to cancer immunotherapy, T cell engagers, and antibody-based therapeutics is preferred. Experience with clinical study operations teams and understanding of clinical drug development strategic planning of clinical research; working knowledge of ICF, ICH GCP, GLP, regulatory compliance and FDA standards. Proven ability to efficiently and effectively manage multiple competing priorities and deliver results successfully. Proven success leading teams, working collaboratively in a cross-functional environment, and motivating team members to drive toward success Final level based on qualifications and experience Role is based in New York and hybrid (4 days/week in office)
Technical Skills / Core Competencies
Is a team player who is able to participate in collaborative, cross-functional projects while being adept in working efficiently as an individual Strong analytical and problem-solving skills Excellent communication and interpersonal skills Strong project management and organizational skills Excellent troubleshooting and multi-tasking skills, attention to detail Ability to effectively and collaboratively work on global cross-functional teams Comfortable operating in a fast-paced environment and able to multi-task and adjust workload based upon changing priorities
Physical Requirements
Sedentary - primarily involves sitting and/or standing. Communicates with others on a daily basis to exchange information. 4 days per week onsite required
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Management and Manufacturing Referrals increase your chances of interviewing at Cellectis by 2x Get notified about new Operations Manager jobs in
New York, United States . New York, NY $130,000.00-$160,000.00 1 month ago New York, NY $152,000.00-$214,000.00 2 weeks ago New York, NY $145,954.00-$167,851.00 1 week ago Bronx, NY $120,000.00-$150,000.00 2 weeks ago New York, NY $128,100.00-$168,000.00 2 weeks ago New York, NY $100,000.00-$120,000.00 1 month ago Brooklyn, NY $80,000.00-$100,000.00 3 weeks ago New York, NY $54,000.00-$65,000.00 4 days ago Strategy Operations Manager, Creative Ad Products
New York, United States $103,200.00-$244,889.00 3 weeks ago New York, NY $75,000.00-$85,000.00 2 weeks ago Strategy & Operations - General Manager (Worker Operations)
New York, NY $135,000.00-$220,000.00 1 week ago New York, NY $180,000.00-$280,000.00 1 week ago New York, NY $125,000.00-$145,000.00 4 days ago New York, United States $100,000.00-$115,000.00 3 weeks ago Retail Store Inventory and Operations Manager
New York, NY $60,000.00-$70,000.00 3 weeks ago Brooklyn, NY $85,000.00-$115,000.00 2 weeks ago New York, United States $95,000.00-$120,000.00 3 weeks ago Professional Services Operations Manager
New York, NY $100,000.00-$110,000.00 4 days ago Strategic Operations Manager, Uber Direct
New York, NY $106,000.00-$118,000.00 1 week ago Queens, NY $100,000.00-$110,000.00 6 days ago New York, United States $30.00-$40.00 1 month ago New York, NY $93,000.00-$116,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr