SUMMARY/JOB PURPOSE:
The Senior Director, Clinical Pharmacology & Pharmacometrics has strong scientific, technical and leadership skills to develop and implement clinical pharmacology and modeling & simulation strategies to advance drug candidates across various stages of the development. Working closely with partners from discovery and development, the individual is responsible for providing strategic and technical subject matter expertise as will as scientific oversight for the clinical pharmacology and pharmacometrics support of several programs in Exelixis’ portfolio. The Senior Director contributes to growth of the department and will mentor or manage junior clinical pharmacologists.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Develop, implement and/or supervise clinical pharmacology and pharmacometric strategies to drive Exelixis programs through all the stages from research through post-marketingServe as the clinical pharmacology lead on several project teams, providing subject matter expertise on PK/PD, biopharmaceutics, drug-drug interactions and quantitative pharmacologyProgress small molecules and biologics through development milestones including IND/CTA, EOP2 and marketing applicationsOversee and/or conduct PK/PD and exposure-response analyses using relevant state of the art modeling and simulation techniques to support human PK predictions, dose selection and optimization, trial designs, risk/benefit assessments, Go/No-Go decisions, regulatory submissions, and publicationsWork collaboratively with functional partners including Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations and Regulatory to deliver on project and corporate objectivesSupport functional area reviews for due diligence evaluationsDrive external scientific visibility and publication objectivesWork with internal and external scientific experts to evaluate new methods to maintain cutting edge techniques, models, and capabilitiesAssure the implementation and adherence to SHE policies, GXPs compliance, and regulatory standards in the clinical pharmacology programsTrain and mentor junior staff to develop and expand their expertise and encourages them to create innovative solutions that will increase scientific knowledge and technical capabilitiesSUPERVISORY RESPONSIBILITIES:
Supervise staff, including hiring, scheduling, and assigning work, reviewing performance, salary review, promotion, transfer, demotion, or termination.Directly supervises full time employees.EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
PhD in related discipline and a minimum of 12 years of relevant experience in the pharmaceutical industry; or,Equivalent combination of education and experience.Experience/The Ideal for Successful Entry into Job:
Minimum 12 years experience in clinical pharmacology and pharmacometricsExperience in development of small and/or large molecules and new modalitiesRecord of supporting drug candidates at various stages of development within the clinical pharmacology functionTrack record in utilization of modeling and simulations to advance drug developmentSubmission of IND/NDA/BLA and global marketing applicationsExperience in the Oncology therapeutic area is preferredContributions to translational science and precision medicine objectivesKnowledge/Skills:
Expert-level understanding of the principles of clinical and quantitative pharmacology Strong quantitative skills including population PK models, advanced mechanistic PK/PD models, disease models and PBPK modelsDeep knowledge of regulatory guidance related to nonclinical and clinical pharmacology for small molecules and biologicsExcellent interpersonal, verbal and written communication skills and the ability to convey complex technical information clearly and deliver effective presentationsAbility to communicate and collaborate cross-functionallyAbility to guide major projects to successful completionAbility to adapt, work through conflicts, and persuasively influence outcomesEffectively cope with change and is comfortable changing direction and acting without complete information.Demonstrated ability to develop and present sound proposals and recommendations and influence and motivate others to achieve objectivesThrives in a fast-paced business environmentApplied knowledge of GLP and GCP regulationsJOB COMPLEXITY:
Function in a highly matrixed team environmentEstablish collaborative networks between functional areasFind creative solutions to unique and complex problemsManage high performance teamsWORKING CONDITIONS:
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.
SUMMARY/JOB PURPOSE:
The Senior Director, Clinical Pharmacology & Pharmacometrics has strong scientific, technical and leadership skills to develop and implement clinical pharmacology and modeling & simulation strategies to advance drug candidates across various stages of the development. Working closely with partners from discovery and development, the individual is responsible for providing strategic and technical subject matter expertise as will as scientific oversight for the clinical pharmacology and pharmacometrics support of several programs in Exelixis’ portfolio. The Senior Director contributes to growth of the department and will mentor or manage junior clinical pharmacologists.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Develop, implement and/or supervise clinical pharmacology and pharmacometric strategies to drive Exelixis programs through all the stages from research through post-marketingServe as the clinical pharmacology lead on several project teams, providing subject matter expertise on PK/PD, biopharmaceutics, drug-drug interactions and quantitative pharmacologyProgress small molecules and biologics through development milestones including IND/CTA, EOP2 and marketing applicationsOversee and/or conduct PK/PD and exposure-response analyses using relevant state of the art modeling and simulation techniques to support human PK predictions, dose selection and optimization, trial designs, risk/benefit assessments, Go/No-Go decisions, regulatory submissions, and publicationsWork collaboratively with functional partners including Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations and Regulatory to deliver on project and corporate objectivesSupport functional area reviews for due diligence evaluationsDrive external scientific visibility and publication objectivesWork with internal and external scientific experts to evaluate new methods to maintain cutting edge techniques, models, and capabilitiesAssure the implementation and adherence to SHE policies, GXPs compliance, and regulatory standards in the clinical pharmacology programsTrain and mentor junior staff to develop and expand their expertise and encourages them to create innovative solutions that will increase scientific knowledge and technical capabilitiesSUPERVISORY RESPONSIBILITIES:
Supervise staff, including hiring, scheduling, and assigning work, reviewing performance, salary review, promotion, transfer, demotion, or termination.Directly supervises full time employees.EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
PhD in related discipline and a minimum of 12 years of relevant experience in the pharmaceutical industry; or,Equivalent combination of education and experience.Experience/The Ideal for Successful Entry into Job:
Minimum 12 years experience in clinical pharmacology and pharmacometricsExperience in development of small and/or large molecules and new modalitiesRecord of supporting drug candidates at various stages of development within the clinical pharmacology functionTrack record in utilization of modeling and simulations to advance drug developmentSubmission of IND/NDA/BLA and global marketing applicationsExperience in the Oncology therapeutic area is preferredContributions to translational science and precision medicine objectivesKnowledge/Skills:
Expert-level understanding of the principles of clinical and quantitative pharmacology Strong quantitative skills including population PK models, advanced mechanistic PK/PD models, disease models and PBPK modelsDeep knowledge of regulatory guidance related to nonclinical and clinical pharmacology for small molecules and biologicsExcellent interpersonal, verbal and written communication skills and the ability to convey complex technical information clearly and deliver effective presentationsAbility to communicate and collaborate cross-functionallyAbility to guide major projects to successful completionAbility to adapt, work through conflicts, and persuasively influence outcomesEffectively cope with change and is comfortable changing direction and acting without complete information.Demonstrated ability to develop and present sound proposals and recommendations and influence and motivate others to achieve objectivesThrives in a fast-paced business environmentApplied knowledge of GLP and GCP regulationsJOB COMPLEXITY:
Function in a highly matrixed team environmentEstablish collaborative networks between functional areasFind creative solutions to unique and complex problemsManage high performance teams#LI-JD1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $246,000 - $348,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.