Principal Scientist/ Associate Director, Bioanalytical Sciences

Agenus Lexington , MA 02421

Posted 3 months ago

The incumbent is expected to demonstrate competency in setting up bioanalytical assays, development and implementation of strategic bioanalytical plans for key immune oncology assets, as well as providing scientific expertise and guidance to project teams and management.

Responsibilities

  • Provide technical expertise for evaluation and selection of PK/ADA and Nab methodology approach and format.

  • Drive the development, qualification and validation of bioanalytical methods for PK, ADA and Nab assays in compliance with the appropriate regulations and regulatory agency expectations.

  • Identify and manage Contract Research Organizations (CROs) to support assay development, validation and clinical sample testing.

  • Provide logistical support in collaboration with the bioanalytical sample manager and CROs for clinical studies (including, but not limited to, sample collection/processing procedure, shipping instructions, sample reconciliation, etc.).

  • Oversee sample testing, monitor data quality and work closely with the clinical pharmacology group to support data analysis and interpretation.

  • Lead discussions and decisions related to bioanalytical assessment for each drug candidate and define the appropriate messaging associated with written documentation of such assessments.

  • Author, review and finalize validation reports, relevant sections of an IND and a BLA, and responses to regulatory agency questions regarding bioanalytical methods and sample analysis.

  • Effectively collaborate with a fully integrated team to facilitate the success of projects.

Qualifications

The candidate will have a proven scientific background with a

  • PhD or MS degree in Biochemistry, Cell Biology, Pharmacology or related field with a minimum of 10 years of relevant experience or a Ph.D. with a minimum of 7 years of pharmaceutical, biotechnology or CRO bioanalytical experience.

  • Extensive knowledge and hands-on experience in ligand binding and Nab assay method development and its application to PK/ADA as evidenced by laboratory skills and/or a good publication record is required.

  • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical and clinical packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.

  • Extensive experience in the outsourcing and external oversight of clinical bioanalytical studies conducted by qualified suppliers.

  • Knowledge of the biomarker assays and platforms for core therapeutic area programs in immune oncology is a plus.

  • Excellent oral and written communication skills and proven ability to work effectively as a member of a multidisciplinary team.

  • Demonstrated capacity to work in a fast-paced environment with strong attention to detail.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Business Development Director (R1054844)

Iqvia Holdings Inc

Posted Yesterday

VIEW JOBS 1/17/2020 12:00:00 AM 2020-04-16T00:00 Job Description Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. Associate Business Development Director Location: US – Greater Boston area, NY/NJ, VA/DC Metro, CA areas The Associate Business Development Director works collaboratively with other colleagues to increase sales within the life sciences industry. Responsibilities include full cycle sales including: target identification, securing and managing client meetings, listening and understanding client needs, addressing client concerns/objections, managing Subject Matter Experts in defining opportunities, proposing solutions, negotiating, obtaining SOWs and closing the deal. Our Sales Professionals are expected to quickly develop credibility with customers/prospects and build trust through professionalism and knowledge of services and products. Essential Duties and Responsibilities: * Prospect accounts focusing on products and services * Identify and develop new accounts and follow up on existing leads * Develop and maintain productive relationships with key target accounts * Manage assigned accounts to generate both incremental and repeatable annual business * Initiate and manage RFI and RFP process and negotiate terms for all account programs and projects * Work collaboratively with the Professional Services Organization to ensure a complete and professional delivery of software and service solutions * Expand product portfolio in the PV market * Collaborate with Executives and SMEs to maximize account coverage * Maintain knowledgeable understanding of changing regulatory guidelines and mandates affecting the industry community Job Experience: * Must demonstrate a sustained (6+ years) and successful track record selling professional services to Pharmaceutical, Biotech, Medical Device, and/or Clinical Research Organizations * Demonstrated track record of success working with senior level management in a fast-paced growth environment is essential * Full sales cycle experience is required: Prospect, Identify Opportunities, Propose Solutions (writing proposals), Negotiate, Close * Strong written and verbal English skills, quality-oriented proposal writing and proposal management experience * Ambitious, driven and self-motivated personality adaptable to a fast-paced high volume and high velocity sales organization * Bachelor's degree or higher required * Willing to travel throughout the US, estimated up to 90% * Reside in the greater Boston area, NY & NJ area, VA/DC metro area or CA * Highly preferred capabilities: * Possess an understanding of the regulatory pharmacovigilance process for both pre-marketed and post-marketed stages of a product * Selling drug safety consulting services and products * Experience working with Regulatory Affairs Departments, Product Safety related departments, or Regulatory Submissions. * Background in Software as a Service (SaaS) market * Experience with data-mining or statistical signal detection products IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled' We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™ Job ID: R1054844 Apply Now Not ready to Apply? CHECK OUT OUR SIMILAR JOBS * Business Development Jobs * Account Manager Jobs * Jobs in Cambridge, Massachusetts * Business Development Jobs Cambridge, Massachusetts Iqvia Holdings Inc Lexington MA

Principal Scientist/ Associate Director, Bioanalytical Sciences

Agenus