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Director/Assoc. Director, Translational Operations

Hybrid from Oakland, CA or Cambridge, MA

Company Overview:

At Aditum Bio our mission is to provide access to medicines to patients in need.   Co-founded by industry veterans Joe Jimenez, former CEO of Novartis and Mark Fishman, former President of the Novartis Institutes for Biomedical Research, the firm in-licenses promising therapies and advances them into Phase 1 and Phase 2 clinical studies to enable proof of concept.   The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual market launch, to reach patients in need.

Position Responsibilities:

  • Work closely with Clin Ops/clinical CRO, program management, quality assurance and translational development to support clinical sample handling and reconciliation.
  • Liaise between vendors (e.g. bioanalytical, specialty labs) and internal Aditum stakeholders to ensure smooth clinical sample collection, clinical site processing, shipment, receipt, analysis and storage of samples. 
  • Ensure timely and documented query resolution between Lab and CRO/clinical site.
  • Track, generate status reports, sample manifests and other sample management-related documents as needed.
  • Assist in development of Data Transfer Agreement(s) between lab vendor(s), CRO(s), and Aditum portfolio companies, including fields for reconciliation and frequency of transfers aligned with study progression needs.
  • Assist with lab manual/sample collection instructions, kit build and site training (sample processing).
  • Execute plans in accordance with regulatory guidelines and expectations. 

Position Qualifications:

  • BS degree (pharmaceutical/biotechnology industry with at least 5 years of experience as CRA or with sampling handling and database management).
  • Experienced building and managing collaborations with vendors, clinical CRO and clinical site personnel.
  •  Ability to be hands-on, meticulous, strong communication skills, quick to respond to queries, sample emergency management, etc.
  •  Ability to identify, prioritize and resolve critical issues; flexible and skilled at juggling multiple projects.
  • Strong track record in effectively collaborating  with scientific and operational colleagues.
  • Provide oversight and coordination within and across portfolio companies.

 

 

 

We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

 

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