Senior Director, Clinical Pharmacology

Title:Sr. Director, Clinical Pharmacology

Reports to:SVP, Clinical Development

Location:US - Remote

Position Overview:

As Company continuesto advance the development of our broad portfolio, weareseekingahighlymotivated scientist to be responsible for designing clinical studies and performing, interpreting, and reporting Pharmacokinetic/Pharmacodynamic (PK/PD) results.

This individual will provide support in characterizing the clinical pharmacology profile of assets developed by Company as part of the overall pipeline. Specifically, the incumbent will support the pipeline by constructing, validating, and implementing disease, placebo, exposure response, and appropriate PK/PD models to evaluate risk/benefit and facilitate drug development decisions.Basedonexperience,thispositioncouldserveasaClinicalPharmacology representativeon study and project teams and will contribute to the planning, implementation and organization of regulatory filings along with presentation of PK/PD data to internal cross-functional teams and external collaborators. Thispositionwillreport tothe SVPofClinical Development.

Responsibilities:

Thesuccessfulcandidatemustbeabletoperformeachofthefollowingsatisfactorily:

·Oversee and support a portfolio of clinical assets

·DesignPhaseIstudiesandcollaboratewithclinicalteams (e.g. Clinical Operations, Research Bioanalytical scientists, Biometrics, and Clinical Development)to select the mostappropriatePK sampling strategy for Phase II-III studies

·Perform,supervise,andreportPKandPK/PDanalysesforCompany assetsastheyprogress through clinical development

·Capable of integrating pharmacokinetic, pharmacodynamic, and safety data from multiple sources to optimize dosing for patient populations across the development continuum will be essential

·Interact withscientists,medical directors,and Technical Operations /RegulatoryAffairs personnel forthe timely completion ofclinical studies andregulatoryfilings

·Participate inmulti-disciplinarystudyteams andrepresent the function on project teams

·Contributeto protocol sections, analysis plans, study reports as well as regulatorydocuments (INDs, CTAs, NDAs, MAAs and Investigator's Brochure)

·Maintainandenhancetechnicalanddrugdevelopmentexpertise(e.g.,trainingcourses,external meeting attendance)

·Understand the legal and complianceenvironmentand drive collaborationwith the Legal and Compliance team

·Represent the Company Values in all interactions across allfunctions by supporting ateam approach to focus on our patients and customers as our top priorities

Requirements:

Education and Experience:

·Ph.D. degree or equivalent in Pharmaceutics, Pharmacology, Pharmacokinetics or PharmD with 12+ years of industry or equivalent experience in Clinical Pharmacology or similar background

·Strong theoretical background and hands-on experience interpreting non-clinical and clinical dose-response and PK/PD data to inform clinical study designs and drug development decision-making is required

·Neuroscience background strongly preferred

·Proficiency with analysis software (e.g., WinNonlin, Phoenix NLME, NONMEM, or other commonly used platforms) strongly preferred

·Prior experience in PK, PK/PD, and ADA of large molecules and/or vaccine therapeutics is preferred

·Knowledge and experience with regulatory guidance related to clinical pharmacology

Competencies and Attributes:

·Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Company’s culture and values – courageous, imaginative, selfless and joyful

• Ability to lead and work with others in a positive and collaborative manner

·Proven ability to work independently, proactively, and effectively

·Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, integrated, team-oriented setting

·Learning agility and 'scalability' to take on increasing responsibility as Company grows

·Understanding the legal and compliance environment

·Ability to have fun and thrive in a growing, diverse and inclusive work environment