SUMMARY:  The Principal Scientist works with a fast-paced team in drug Discovery and Development to provide scientific direction and strategy by being an expert in the design/interpretation of both in vitro and in vivo ADME experiments.  The successful candidate will utilize their strong knowledge in ADME to equally partner with team members within medicinal chemistry, toxicology, pharmacology, as well as with CMC, clinicians and clinical development team to drive programs forward. The Principal Scientist will actively engage with key stakeholders and leaders to achieve critical milestone for Exelixis’ pipeline.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Lead DMPK in project teams and equally partner cross-functionally to drive programs forward.
• Strategize and implement DMPK strategy, while closely working with leadership to evolve DMPK strategies for small molecule programs at Exelixis.
• Stay scientifically cutting edge and identify and integrate emerging science to advance the portfolio.
• Prepare high quality Regulatory documents including IND, CTA and NDA filings; assist in the preparation of DMPK components of nonclinical and clinical study protocol design, nonclinical and clinical study reports, IB, PMP.
• Maintain external scientific visibility through publication.
• Foster a science-driven, goal-oriented culture that values innovation, teamwork, agility, transparency, accountability, and empowerment
• Conduct scientific presentations to senior management, project teams, and internal/external collaborators
• Comply with company health and safety policies and general laboratory practices.
• Other duties as assigned

SUPERVISORY RESPONSIBILITIES:

• May manage scientists within Drug Discovery Sciences.

EDUCATION/EXPERIENCE/SKILLS: 

Education:

• Ph.D. in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or other relevant field and a minimum of 5 years of relevant experience in the biopharmaceutical industry, with good understanding of ADME concepts.

Experience:

• Leading project teams to identify clinical candidates and progressing molecules into clinical trials.
• Proven track record of elucidating ADME properties of molecules through generation and testing of data-driven hypotheses.
• Extensive experience in identifying clinical candidates through balancing ADME, pharmacology and toxicology properties.
• Experience in leading a multi-disciplinary team to deliver impactful results and mechanism of action insights in support of drug discovery efforts.
• Track record of contributions to regulatory filings
• Managerial experience of in-house team and CROs is preferred.
• Experience with biologic therapeutics is a plus.

Knowledge/Skills/Abilities:

• Scientific and technical knowledge around pharmacokinetics, drug metabolism and drug transporters, including enzymology and enzyme kinetics.
• Demonstration of independent thought/creativity in science and drug research.  Experience in applying emerging science and technologies to strengthen and improve research capabilities.
• In-depth knowledge of current practices and issues in DMPK (including regulatory requirements).  Knowledge beyond DMPK such as toxicology and pharmaceutical development is a plus.
• Understanding of fundamental pharmacokinetic and quantitative pharmacology (PK/PD) principles and hands-on experience with modeling tools such as SAAM, NONMEM, R/S-Plus, MATLAB, SAS, GastroPlus and Simcyp is a plus.
• Excellent collaborative verbal and written communication skills.
• Keen desire to grow and develop the careers of team members.
• Demonstrates strong leadership and desire to influence and make decisions; able to work well within multi-disciplinary teams.

JOB COMPLEXITY:

• Works on problems of diverse scope where analysis and review of data requires evaluation of identifiable factors.  Works on ADME complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Exercises independent judgment in selecting methods, techniques, and evaluation criteria for obtaining results.
• Networks with key contacts outside own area of expertise.

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 $131,500 - $195,500 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.

Education:

• Ph.D. in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or other relevant field and a minimum of 5 years of relevant experience in the biopharmaceutical industry, with good understanding of ADME concepts.

Experience:

• Leading project teams to identify clinical candidates and progressing molecules into clinical trials.
• Proven track record of elucidating ADME properties of molecules through generation and testing of data-driven hypotheses.
• Extensive experience in identifying clinical candidates through balancing ADME, pharmacology and toxicology properties.
• Experience in leading a multi-disciplinary team to deliver impactful results and mechanism of action insights in support of drug discovery efforts.
• Track record of contributions to regulatory filings
• Managerial experience of in-house team and CROs is preferred.
• Experience with biologic therapeutics is a plus.

Knowledge/Skills/Abilities:

• Scientific and technical knowledge around pharmacokinetics, drug metabolism and drug transporters, including enzymology and enzyme kinetics.
• Demonstration of independent thought/creativity in science and drug research.  Experience in applying emerging science and technologies to strengthen and improve research capabilities.
• In-depth knowledge of current practices and issues in DMPK (including regulatory requirements).  Knowledge beyond DMPK such as toxicology and pharmaceutical development is a plus.
• Understanding of fundamental pharmacokinetic and quantitative pharmacology (PK/PD) principles and hands-on experience with modeling tools such as SAAM, NONMEM, R/S-Plus, MATLAB, SAS, GastroPlus and Simcyp is a plus.
• Excellent collaborative verbal and written communication skills.
• Keen desire to grow and develop the careers of team members.
• Demonstrates strong leadership and desire to influence and make decisions; able to work well within multi-disciplinary teams.