Study Director Jobs in Pinole, CA (NOW HIRING)

Summary/Job Purpose (Basic purpose of the job):

The DMPK Director has strong scientific, technical and leadership skills to develop and implement DMPK and modeling & simulation strategies to advance drug candidates from discovery to development stage and build comprehensive DMPK packages to enable successful drug registration. The senior director is responsible for providing strategic and technical subject matter expertise as well as scientific accountability and oversight for the DMPK support of several programs in Exelixis' portfolio. The Senior Director contributes to growth of the Clinical Pharmacology and Pharmacometrics department and may mentor junior scientists.

Essential Duties/Responsibilities:

• Lead the Translational IND- and NDA-enabling ADME work; characterize the ADME properties of molecules and collaborate to establish in vitro to in vivo correlations; ensure that all DMPK studies and analyses are consistent with regulatory guidance
• Analyze and interpret preclinical pharmacokinetic and pharmacodynamic data to inform drug development decisions
• Closely partner with Discovery to evolve translational ADME strategies and collaborate on roll-out, education and execution to ensure deep integration of knowledge from Discovery to Development
• Closely partner with Clinical Pharmacology and pharmacometrics to ensure a seamless transition of molecules to development and generate the preclinical data needed to inform the Clinical Pharmacology development plans
• Work collaboratively with other functional partners including Translational Medicine, CMC, Toxicology, Clinical Development and Regulatory to deliver on project and corporate objectives
• Prepare high quality regulatory documents including IND, CTA, and NDA filings; prepare DMPK components of nonclinical and clinical study protocols, nonclinical and clinical study reports, and investigator brochures
• Support functional area reviews for due diligence evaluations
• Conduct scientific presentations to senior management, project teams, and internal/external collaborators
• Stay up-to-date with advancements in DMPK research and identify and integrate emerging science to advance the portfolio
• Maintain external scientific visibility through publications
• Foster a science-driven, goal-oriented culture that values innovation, teamwork, agility, transparency, accountability, and empowerment
• Comply with company health and safety policies and general laboratory practices.

SUPERVISORY RESPONSIBILITIES:

• No supervisory responsibilities.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• PhD degree in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or other relevant field and a minimum of 12 years of relevant experience in DMPK in the pharmaceutical industry

Experience:

• Minimum 12 years experience in DMPK
• Expert knowledge of in vitro and in vivo ADME studies
• Strong experience of managing external DMPK work at CROs
• Extensive experience in identifying clinical candidates through balancing ADME, pharmacology and toxicology properties and progressing molecules into clinical trials
• Solid experience in utilization of physiologically-based and empirical modeling and simulations techniques to characterize drug-drug interactions and biopharmaceutics liabilities
• Experience with submission of IND/NDA/BLA and global marketing applications
• Experience with antibody drug conjugates is a plus

Knowledge, Skills and Abilities:

• Extensive scientific and technical knowledge around drug metabolism and drug transporters, including enzymology and enzyme kinetics and in vitro to in vivo extrapolation
• Demonstration of independent thought/creativity in science and drug discovery
• 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), PKPD and translational sciences
• Keen desire to grow and develop the careers of team members
• Demonstrates strong leadership; and has the ability to influence and make decisions
• Excellent collaborative verbal and written communication skills
• Able to work well with multi-disciplinary teams
• 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
• Thrives in a fast-paced business environment
• Function in a highly matrixed team environment
• Establish collaborative networks between functional areas
• Find creative solutions to unique and complex problems
• Manage within performance teams

Work Environment/Physical Demands:

Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic workstations, to ensure a comfortable workspace.

Travel requirements can be listed by stating up to certain % of time traveling.

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $183,000 - $260,000 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.

If you have a disability and need an accommodation in relation to the application and/or recruitment process, please email us at: recruiting@exelixis.com.

WORKING CONDITIONS:

Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

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.