Senior Director Biomarker Sciences Inflammation Immunology

High Profile Global Pharmaceutical company is seeking a

Senior Director, Inflammation, Biomarker Sciences

Company is seeking a biomarker expert to head their Inflammation/Immunology Group. We are seeking an experienced, exceptional scientist who will work in a dynamic, multidisciplinary matrixed team environment to generate and interpret data from translational and clinical studies.

The candidate will work closely with the Research Biology and Therapeutic leadership teams to develop and support the strategic direction in the field of inflammation focused on the development of therapies for rheumatic diseases and inflammatory bowel disease. The incumbent is responsible for leading of a group focused on developing and delivering on a clinical biomarker strategy to evaluate target engagement, pharmacodynamic assessments to inform dose selection, elucidate drug mechanisms of action, potential combination strategies, patient stratification and/or selection and to investigate mechanisms of resistance (innate and acquired).

Biomarker Sciences at Company Sciences

The Biomarker Sciences Department is part of Companys Development organization, and leads early and late stage clinical biomarker research and development activities for the pipeline and supports the late stage portfolio for regulatory, translational development, diagnostic partnering and life cycle management.

Essential Duties and Job Functions

• Provides expert guidance to multi-disciplinary teams and senior management.


• Leads the analysis of biomarkers for Company clinical studies by working with key internal stakeholders and external CROs as needed to generate biomarker study reports.


• Develops and mentors Biomarker leads.


• Responsible for the development of the biomarker section of Company clinical protocols in trials and represents biomarker strategy at key review meetings and plans execution.

Responsibilities

• This position will report to the Head of the Inflammation/Fibrosis Therapy Area and be a member of the Biomarker Sciences Leadership team and relevant Development cross-functional leadership teams.


• Lead a group of biomarker scientists responsible for multiple programs and oversee biomarker strategy development and implementation of the inflammation aspects of Companys program ensuring effective utilization of biomarker approaches to address key program questions


• Work closely with the Biomarker Sciences leadership team to ensure alignment and synergies are captured across therapeutic areas.


• Act as the translational representative on Project teams to advance the Company portfolio in inflammatory diseases.


• Use biomarkers to identify opportunities to study Company compounds in new indications/combinations.


• Use biomarkers in developing an approach for immunologic safety monitoring and assessment.


• Identify, establish and oversee external collaborations with key opinion leaders, academic sites, and CROs to advance our understanding of disease pathways and prognostic/predictive biomarkers.


• Collaborate with Research Biology, Development (Clinical Research), Clinical Pharmacology, Data Science (Bioinformatics and Biostatistics) functions to create synergy in developing biomarker strategies and translational approaches.


• Strong experimental background and experience in hypothesis-driven biological/translational research with demonstrated ability to execute well-designed experiments in inflammation.


• Experience with genomic, epigenetic, gene expression, metabolomics, multiplexed protein detection or other related emerging platforms or data sets is desirable.


• Must be able to work independently and effectively on multiple programs in a fast-paced matrixed environment.


• Excellent collaboration, communication, and interpersonal skills are required to engage and be productive within a high achieving team environment.


• Must be team and detail-oriented, motivated, and results focused.

Technical Skills

• Demonstrated expertise in immunology or related field


• Ability to integrate complex scientific ideas, generate testable hypotheses, and execute


• Analysis and interpretation of biomarker data in preclinical and clinical setting


• Experience with multi-dimensional data analysis is beneficial


• Broad understanding of drug discovery and development in both early and late stage
  development and familiarity with regulatory approval process.


• Knowledge of biomarker discovery and development, assay development/validation, clinical discovery of biomarkers, and MoA/translational research.


• Authoring of biomarker strategy documents, biomarker specific portion of clinical protocols, and regulatory documents


• Basic understanding of technical aspects of companion diagnostics development


• Proven scientific/leadership expertise (working in teams, managing people/projects commensurate with a senior level)


• Proven publication record


• Strong verbal and written communication skills


• Understanding of IP, contracting terms and provisions

Experience

PhD and/or post-doc training in the area of inflammatory autoimmune diseases, immunology, or other related medical science field with a minimum of 15 years of relevant biotechnology or pharmaceutical industry experience. Candidate must be detail-oriented with excellent record keeping and organizational skills. Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced and dynamic multi-disciplinary environment- there is also a Director level need - 10-12 years experience (Phd and Post Doc training and requires Biomarker experience)