Skip to main content

Search jobs

Search jobs

Over AbbVie

De missie van AbbVie is het ontdekken en leveren van innovatieve geneesmiddelen die vandaag een oplossing bieden voor ernstige gezondheidsproblemen en de medische uitdagingen van morgen aanpakken. We streven ernaar om een grote impact te hebben op het leven van mensen in verschillende belangrijke therapeutische domeinen: immunologie, oncologie, neurowetenschappen, oogzorg, virologie, vrouwengezondheid en gastro-enterologie, naast producten en diensten uit de portefeuille van Allergan Aesthetics. Bezoek www.abbvie.com voor meer informatie over AbbVie. Volg @abbvie op Twitter, Facebook, Instagram, YouTube en LinkedIn.

Senior Biomarker Program Manager

Primary Worcester, Massachusetts Secondary Waukegan, Illinois Job ID 2209058 Categorie Research and Development Afdeling AbbVie

Senior Program Manager, Biomarkers

 

There is an exciting opportunity within the Precision Medicine Biomarker Program Management (BPM) group at AbbVie.  The Precision Medicine group uses advanced methods to discover biomarkers for use in clinical trials. Biomarkers may be used to confirm the molecular targets of a drug, predict efficacy, aid in patient selection and/or inform future drug development strategies.  Biomarker research is an essential component for helping serve patient needs and furthering AbbVie’s innovative biopharmaceutical pipeline. AbbVie is hiring a Senior Biomarker Program Manager who will connect science and operations to implement and then manage biomarker research in multiple Phase 1-3 clinical trials. This role will employ operational and logistical strategies ensuring clinical trials are executed with quality and efficiency, on-time, within budget, and meet objectives. The project manager achieves these objectives via scientific expertise, strategic thinking, a global mindset and cross-functional collaboration.

RESPONSIBILITIES:

  • Manage the biomarker operations and logistics to align with clinical trial schedule
  • Co-manage with lead biomarker scientist to support regular updates to cross-functional stakeholders for each trial
  • Responsible for relevant clinical study documents and associated systems (including trial blueprint/protocol, Informed consent forms, eCRFs, CSRs, etc.)
  • Oversee EC/IRB biomarker related inquiries, ensuring consistent responses across studies while maintaining AbbVie biomarker standard language and study timelines
  • Manage biomarker vendor selection and research scope; manage contract execution and vendor oversight in compliance with AbbVie's processes, procedures and applicable regulations
  • Responsible for the accurate forecasting and tracking of study costs associated with sample and result management, bioanalytical assays, logistics and shipping as needed.  Work with cross-functional areas to continuously improve processes.
  • Responsible for generating study related training for the study team, study sites and vendors for each trial
  • Oversee sample analysis and data transfer; ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct databases.  Responsible for sample management, storage, and/or destruction per requirements.
  • Deposit biomarker related documents to the Trial Master File, ensuring that documentation standards are followed and are ‘inspection-ready’
  • Proactively identify and resolve and/or escalate study-related issues.
  • Apply and adhere to ICH/GCP, bio-storage procedures, bio-sample management best practices and ethical guidelines Serve as a subject matter expert (SME) and resource for one or more processes in BPM
  • Spearhead process improvement initiatives or improving efficiency as needed, as well as instructions and manuals for internal training purposes
  • Manage multiple contract or permanent employees if needed
  • Contribute to a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels
  • Balance multiple priorities in a fast-paced, team-based environment and work independently
     

QUALIFICATIONS:
Required:

  • PhD Degree with life sciences background, including biomarkers and 4+ years project management, and/or clinical operations experience
  • Master’s Degree with life sciences background, including biomarkers and 9+ years project management, and/or clinical operations experience
  • Bachelor’s Degree with life sciences background, including biomarkers and 12+ years project management, and/or clinical operations experience
  • Expertise in MS Office applications including Excel, Word and PowerPoint
  • Excellent oral and written communication skills in English
  • Organization, attention to details and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skills

Preferred:

  • 2+ years direct clinical/biomarker operation experience, with exposure spanning initiation through study completion preferred
  • Competent in application of standard business procedures (standard operating procedures, International Conference on Harmonization {ICH}, Global Regulations, Ethics and Compliance)
  • Scientific background in biology or related.  Knowledge of immunology, including biomarkers and 4+ years project management and clinical operations is desirable.
  • Ability to work with minimal supervision
  • Experience holding meetings by teleconference and working with colleagues remotely
  • Effectively work in a cross-functional team environment and ability to interact with various levels within the organization as well as vendors
  • Project Management certification a plus


Key Leadership Competencies:

  • Builds strong relationships with peers and cross-functionally with partners outside of team
  • Learns fast, grasps the “essence” and can change course quickly when required
  • Raises the bar and is never satisfied with the status quo
  • Creates a learning environment, open to suggestions and experimentation for improvement
  • Embraces the ideas of others, nurtures innovation

Keywords:  Biomarker operations, oncology, clinical trial operations, project management

**Equal Opportunity Employer Minorities/Women/Veterans/Disabled**

Job title is commensurate with experience. 

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

Meest recente vacatures

Aanmelden voor job alerts

Sluit u aan bij ons talentennetwerk en ontvang nieuws en job alerts van AbbVie in uw mailbox.

Geïnteresseerd inSelecteer een categorie of locatie. Klik op ‘Add’ (toevoegen) om uw job alert aan te maken.

Onze Gebruiksvoorwaarden, ons Cookiebeleid en ons Privacybeleid leggen uit hoe we uw gegevens verzamelen en gebruiken en wat uw rechten zijn. Door ons uw gegevens te verstrekken, verklaart u deze documenten te hebben gelezen en gaat u ermee akkoord dat AbbVie u sms-berichten en job alerts per e-mail kan toesturen.

Onlangs bekeken functies

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Click here to find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application