Head of Clinical Pharmacology

Overall Description

The Head of Clinical Pharmacology will be responsible for the design, execution, leadership and implementation of Clinical Pharmacology strategy across Arcus's clinical portfolio programs. This position will report into the CMO. He/she should have a strong knowledge of global regulatory oncology practices and extensive experience in designing and executing clinical pharmacology studies. The individual in this position will participate in cross-functional project teams and play a key role in preparation for and execution of interactions with global health authorities. This role will require individuals that have past experience in building-out a clinical pharmacology program and demonstrate strong communication and collaboration skills with cross-functional senior executives.

Job Duties and Responsibilities

Responsibilities include, but are not limited to:

• Collaborate with Clinical Development to characterize human pharmacokinetics, metabolism and biopharmaceutics of clinical compounds, including the design of clinical pharmacology dedicated patient and/or healthy volunteer protocols which may include: drug-drug interaction, absolute/relative bioavailability, hepatic/renal impairment, food effect dose-scheduling studies.
• Authoring/reviewing/approving clinical protocols, analysis plans, study reports and regulatory submissions
• Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans
• Maintaining and establishing relationships and agreements with contract vendors
• Evaluating departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
• Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
• Understanding the impact of decisions and actions on the business and consulting with colleagues and management as applicable
• Participating in and collaborating with individuals from across the business in special projects
• Developing and presenting training within and outside the department

Qualifications

Education/Experience:

• At least 10 years' experience and a PhD, PharmD or MD degree with emphasis in clinical pharmacology, pharmacokinetics or a related scientific discipline
• Proven track record of extensive experience in population modeling and simulations. Expertise with standard modelling and simulation software (NONMEM, S-Plus/R, etc) is required. Knowledge of other software - e.g. WinNonlin required.
• Direct experience with negotiating/interacting with global regulatory authorities (recent experience in oncology is strongly preferred)
• Successful experience with NDA/BLA filings (recent experience in oncology is strongly preferred)
• Experience with and knowledge of accelerated/conditional filing requirements
• Thorough knowledge of current and emerging scientific standards regulatory requirements for assigned territories
• Excellent written and oral communication skills and ability to convey complex technical information clearly
• Confidence and ability to present to and influence senior leaders
• Ability to critically analyze problems and provide creative solutions
• Confidence and discipline to work autonomously
• Genuine curiosity and drive to ask questions - looking for the ‘why' of every project
• Desire to strive for continuous improvement
• Experience in the early and late stage development of both small molecules and biologics (recent experience in oncology is strongly preferred)
• Management and team leadership experience