Director, Immuno-Oncology Clinical Biomarkers, Oncology Early Development

Redwood City, CA, US
Aug 26, 2018
Required Education
Position Type
Full time
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products - Imbruvica, Venclexta, and Empliciti - and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.

AbbVie is expanding its oncology efforts with a focus on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these multiple sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position is located at the AbbVie site in Redwood City, CA.

Director, Immuno-Oncology Clinical Biomarkers

We are searching for a Director of Immuno-Oncology Clinical Biomarkers (I-O CB) to join Oncology Early Development (OED). This is a unique opportunity to lead a team of scientists that drive the strategy and implementation of the clinical biomarker plans across innovative first in-class, cutting edge programs, in the area of Immuno-Oncology.

In this role, you will report directly to the Group Project Leader in Oncology Early Development (OED) and will join an experienced team with a strong track record in developing biotech products. As the Director of I-O CB, you will lead a team of clinical biomarker scientists that participate in cross-functional OED teams. The scope of OED is clinical candidate nomination through the end of clinical proof of concept. As a Director of I-O CB, you will be responsible for the development and execution of comprehensive biomarker plans that will enable science based decision making on the clinical programs. You will liaise with Project Director, Medical Director, preclinical biomarker leads, discovery leads, and experts in pharmacokinetics/pharmacodynamics (PK/PD) to develop and implement the clinical biomarker strategies for OED stage I-O assets. You will also help guide IND enabling preclinical biomarker studies, help draft and review regulatory documents (such as INDs), Investigator Brochures and clinical protocols, design clinical biomarker studies for OED stage compounds. To be successful in this role, you need a deep understanding of cancer immunotherapy and related development, and convincingly articulate the rationale for the biomarker plans to senior management and governance committees within AbbVie. You will be a clinical scientific leader of I-O CB within the organization.

Key goals include:
  • Lead and manage a team that is responsible for I-O- Clinical Biomarkers within OED.
  • Partner with late development clinical and discovery groups to create high quality clinical biomarker strategies for our I-O stage assets in OED to inform the development programs through major stage gates.
  • Mentor, guide and develop the OED clinical biomarker scientists within your team.
  • Help guide IND enabling biomarker studies, and author biomarker sections of protocols, ICFs, IRB responses, regulatory documents.
  • Be responsible for budgeting, timelines and planning for clinical biomarker activities for I-O stage OED assets.
  • Responsible for presenting to AbbVie senior management team and other key stakeholders throughout the organization.
  • Lead biomarker strategies for one or more clinical trials and serve as point of contact for all aspects of clinical biomarker strategy providing scientific expertise and leadership to programs
  • Implement standardized and cutting edge tools to characterize drug mechanisms, potential diagnostic strategies, and for back translation research
  • Lead biomarker subteams to enable cross functional collaboration on biomarker implementation
  • Pro-actively consult primary scientific literature, keep current on state of art technologies and emerging concepts in immuno-oncology
  • Moderate travel will be required between AbbVie sites as well as some travel to visit investigators and key conferences such as ASCO, AACR, ASH, SITC, etc.

  • PhD, MD or MD/PhD degree in life sciences (oncology, immunology, pathology, molecular biology, cell biology or related field) with a strong scientific background in oncology drug development (basic and translational); and experience in designing and executing on clinical biomarker plans.
  • Knowledge of preclinical and clinical drug development is a prerequisite, as is a deep knowledge of Immuno-Oncology drug mechanisms with emphasis on I-O related biomarkers.
  • Strong scientific and people leadership skills.
  • Ability to function in a matrixed team environment.
  • Excellent written and oral presentation skills in the English language.

Preferred Qualifications:

  • Minimum 10 years (12+ years preferred) of experience in translational research and biomarker development at a pharmaceutical/biotech setting.
  • Proven track record of leading successful projects.
  • Experience managing scientific teams: ability to lead and motivate team and bring out the best in others. Ability to delegate appropriate accountability and decision-making to team members.
  • Knowledge of both small and large molecule drug development.
  • Clinical development experience in managing biomarker studies in Ph1 (Ph2 and/or Ph3 experience is a plus).
  • Strong leadership skills, business acumen and be able to think and function independently.
  • Strong scientific background in tumor biology and immuno-oncology supported by publication record in these areas
  • Demonstrated leadership in translational sciences, employing pharmacodynamic, predictive and exploratory biomarkers
  • Experience in analysis of large datasets and knowledge of biostatistics
  • Experience in assay development, qualification and implementing biomarker assays on diverse platforms including IHC/IF, gene expression profiling, flow cytometry
  • Companion diagnostics development experience is a plus
  • Effectively work in a cross-functional team environment, interacting with various levels within the organization as well as vendors/academic sites/KOLs
  • Organization, orientation to details, and effective time management with an ability to adapt to changing priorities

Equal Opportunity Employer Minorities/Women/Veterans/Disabled