The Head of Translational Medicine will act as the strategic leader for Pharamcyclics' translational studies and is responsible for leading biomarker, bioinformatics, assay technology and patient sample management teams in supporting the clinical development of IMBRUVICA. Reporting to the Head of Discovery and located in Sunnyvale, California, this position has a key leadership role in all I MBRUVICA development programs and will work collaboratively with Clinical Sciences, Biometrics, Clinical Operation and Regulatory Departments.
The ideal candidate should have a passion for translational medicine and a proven track record of accomplishments in biomarker and bioinformatics studies for clinical programs, preferably in oncology indications. With a stellar translational scientist background, this leader should have a deep understanding of mechanistic cancer biology and trends in oncology, including immune oncology, therapeutic development. As a skilled and proven organizational leader, this individual should be a well-organized manager, an effective team builder and an influential collaborator who will provide strong organizational, technological and scientific leadership to the Translational Medicine Department. A proven track record on scientific and operational excellence is required. Responsibilities:
- Develop and implement biomarker and diagnostic strategy and lead a department of approximately 20 scientists to support the further development of IMBRUVICA.
- Lead efforts on pharmacodynamic, predictive, prognostic, companion diagnostic and safety biomarker studies and drive mechanism of action and resistance mechanism investigation for IMBRUVICA.
- Manage the development and outsourcing of clinical biomarker studies, select and validate external vendors, oversee biomarker testing and data analysis and support biomarker sections of clinical study protocols, reports and registration activities.
- Present to and participate in Advisory Boards and KOL meetings as needed.
- Contribute to the biomarker and bioinformatics platform for AbbVie's translational sciences across multiple oncology sites. Identify, engage, and ensure the success of translational collaboration across AbbVie's global network and the external scientific community.
- Keep up-to-date with the latest translational medicine advancements and keep informed about current trends in oncology and immune oncology therapeutics development to ensure access to state-of-art thinking/approach.
- Set departmental scientific and business goals and manage employees, resources, budgets and other administrative functions, as required.
- Provide day-to-day scientific, technical and organizational leadership to biomarker, bioinformatics, assay technology and patient sample management teams and manage a portfolio of programs to achieve scientific and operational excellence with strong impact on clinical development.
- Develop a science-driven result-oriented culture with innovation, accountability, transparency and agility.
- Collaborate with senior l eadership to manage company operations and ensure regulatory compliance.
- PhD/MD in Life/Medical Sciences or equivalent with a minimum of 12 years of relevant industrial/academic translational experience in oncology positions of increasing responsibilities.
- Experience in all areas of translational medicine, including biomarker investigation, clinical bioinformatic analysis, clinical assay technology and patient sample management.
- Demonstrated expertise in clinical protocol development, clinical utilization of biomarker assays, biomarker process (related to biosamples, assays and data), and its implementation in clinical development.
- Experience in leading a mid-sized translational group of > 12 people in a biotechnology or pharmaceutical company.
- Proven record in employee development and fostering productivity, accountability and execution with a sense of urgency.
- Experience in strategic planning, project leadership, laboratory and budget management in a matrixed organization.
- Proven leadership in science-driven translational work and track record of translational accomplishment as evidenced by quality and quantity of publications , patents and conference presentations
- Track record of developing efficient translational processes and leading complex cross-functional team collaborations, including managing relationships with academic collaborators and CROs. Ability to effectively balance workflow, resource and timeline in real-time based on strategic direction and priorities.
- Self-starter with strong interpersonal and analytic skills, high ethical standards and excellent written and verbal communication skills.
- A desire to be part of a growing and dynamic company aimed at providing the Magic of Normal to cancer patients and their families.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Location/Region: Sunnyvale, CA