Director, Biomarkers – Pharmacyclics, LLC – Sunnyvale, CA

Oct 13th, 2016 | By | Category:
Job ID: 6076
Job date: 2016-10-13
End Date:

Company : Pharmacyclics 

Country :

Role : Research Scientist 

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Job Description:
Contributes to the drug development pipeline in hematology/oncology and/or solid tumors or inflammatory/immunologic diseases by supporting the implementation of scientifically driven biomarker concept and development plans which are aligned with clinical study protocols.

Directs the activities of translational research scientists performing pre-clinical and proof-of-concept investigations and assay development, phase-appropriate assay validation, and clinical implementation of assays for patient selection.

Has responsibility for strategic development and implementation of plans leading to discovery and clinical translation of study or disease-specific biomarkers, and is accountable for the development and execution of biomarker plans according to pre-specified timelines, with specific alignment to the associated clinical study protocols.

Directs and interprets the subsequent analyses of patient selection or stratification, pharmacodynamic or safety biomarkers, utilizing techniques such as gene mutation and expression analysis, flow cytometry, immuno-histochemistry, ELIZA, in-situ hybridization, disease-specific imaging or routine laboratory diagnostic testing.

Ensures that assigned biomarker program budgets, schedules, and performance standards are attained, and that resultant activities and data are reviewed, from both a short-term and long-term perspective, for desired results.

Establishes close collaborations with other groups within Translational Medicine, and undertakes cross-functional engagement with Clinical Science and Clinical Operations for translation of assays to the clinic, and partners with Discovery Research for back-translational efforts, as well as having involvement with Business Development and Regulatory Affairs activities as needed.

Develops key external academic or industry collaborations and maintains understanding of emerging concepts and maintains scientific leadership in the field.

Ensures compliance with all Pharmacyclics processes and Regulatory requirements. Specifically, this includes working closely with Discovery Research Scientists, Clinical Medical and Operations Leaders, Regulatory Affairs, Compliance, Legal and Biometrics Departments, and presentation of Biomarker Concept and Development Plans to Senior Management Governance Review.

Key Accountabilities/Core Job Responsibilities:
Working within the Translational Medicine Department, with a focus on a leadership role in the conception, design and execution of

Contributing to the infrastructure planning for internal Translational Medicine efforts.

Leading and supervising Translational Medicine laboratory scientists, and working with the Translational Medicine Bioinformatics team to drive biomarker analysis of data generated from Pharmacyclics sponsored studies, and potentially from Investigator Sponsored or Co-Operative group studies, or studies undertaken by potential partners.

Undertaking correlative analysis of biomarker results in disease specific contexts, utilizing an understanding of relevant clinical genetics and disease biology.

Partnering cross-functionally with internal groups including the Translational Medicine Biosample Management team and Pharmacyclics Clinical Operations, and with external groups such as clinical investigative sites and external CROs, to ensure the highest quality clinical sample acquisition and sample handling and storage preparatory to execution of biomarker assays, subsequent data analysis and data transfer.

Supporting the Oncology Clinical Project Leaders in all technical and operational biomarker-related matters.Actively supporting individual clinical trial teams and/or ICTs as required for assigned projects.

Working with the Translational Medicine Biosample Management team and Pharmacyclics Clinical Operations and Clinical Outsourcing to managing relationships with external CROs undertaking sample handling or analysis, providing input into trial-specific agreements and assessment of service level commitments and compliance of CROs involved in biomarker sample analysis.Coordinating interactions between CROs and the Pharmacyclics clinical study team as necessary.

Contributing to the biomarker assessments in designated clinical protocols to develop the central and reference laboratory components, and collaboration with other colleagues in Translational Medicine (and Discovery Research as needed) to develop disease specific biomarker strategies.

Providing expertise and written input on biomarker-related sections in clinical study-related and regulatory documents, such as INDs, IBs, Clinical Study Reports, ad hoc analyses, etc.).

Ph.D, Pharm. D., or M.D. (or equivalent) with expertise in translational biomarker efforts in the fields of hematology/oncology, solid tumors or inflammatory/immunologic diseases.
Demonstrated success in pharmaceutical or biotechnology companies in leading clinical biomarker projects for various programs, preferentially in B cell lymphomas, general oncology, or inflammatory/immunologic disease settings.
Previous scientific and strategic leadership in the biomarker field as evidenced by presentations to conferences/meetings, authorship of peer reviewed publications and patents, and past experience leading biomarker focused research or translational study teams.
Expertise in one or more of core experimental methodologies of Next Generation Sequencing, RNA expression, immuno-histochemistry, in-situ hybridization, flow cytometry, ELIZA, or histologic and pathologic assessment of samples derived from biological matrices.
Excellent organizational skills, team leadership skills and communication skills leading to productive interactions between cross-functional colleagues and external collaborators.

8+ years experience in biomarker or biomarker and associated drug development in a pharmaceutical or biotechnology company, with s ignificant expertise in clinical biomarkers development.

Experience in translational medicine settings with focus of development of small-molecule therapeutics for oncology, immune-oncology or inflammatory and immunology therapeutic applications.

Understanding of clinical trial designs and clinical study operations.

Understanding of the regulatory framework governing tissue and genetic consent and acquisition, assay and storage of patient derived samples.
Development and execution of project timelines and associated budgets.
Development and presentation of written strategic plans and biomarker development plans to internal review processes and Senior Management.
Understanding or past-experience of development of in-vitro or companion diagnostic(s) would be valuable.
Experience in small-molecule kinase inhibitor R&D and associated biomarker programs preferred.

Understanding of lymphoma biology or lymphocyte immunology preferred.
Ability to function in a highly matrixed, cross-functional environment.
Where applicable if managing direct reports:
Directly manages assigned staff member recruitment and on-boarding

Oversees the work of direct reports to ensure on-time, on-target and within-budget results

Provides strategic leadership for one or more scientific functional areas

Provides ongoing coaching, guidance and feedback to ensure direct reports are successful in their work, as well as have the necessary and timely access to information and other resources

Conducts regular one-on-one and any other staff meetings to ensure timely communication with direct reports

Provides formal performance reviews and career development planning for all direct reports

Complies with all company HR policies and procedures, as well as state/federal employment-related laws.

Education Requirements (degree, certifications, etc.):

Requires a Ph.D./Pharm.D or M.D. (or equivalents), with past experience in translational biomarker efforts in the fields of hematology/oncology, solid tumors or inflammatory/immunologic diseases.

Preferred Skills/Abilities :
Experience in small-molecule kinase inhibitor R&D and associated biomarker programs.

Understanding of lymphoma biology or lymphocyte immunology.

Strong understanding and proven track record in genomics/genetics technology and applications to clinical development.

Requeriments :

Skills :

Areas :

Additional Info:

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