Director, Clinical and Quantitative Pharmacology (Remote)

Job Description

Director, Clinical and Quantitative Pharmacology will combine strong pharmacometric skills with a deep biological understanding. They are responsible for independently determining, planning, and executing M&S analyses for an entire drug development program in close collaboration with cross-functional colleagues within the R&D organization. Specific experience and interest in working in population PK/PD or quantitative systems pharmacology is required. The Director determines, plans, and executes technically challenging analyses by using state of the art Modeling & Simulation methodologies to strongly contribute to critical decision making. The Director will lead M&S projects for an entire drug development program to evaluate study design, dose selection, probability of success estimation, portfolio strategy, pediatric extrapolation etc. In this role, it is expected that they will represent M&S with cross-functional drug development teams, proactively advocate for model-based approaches, and clearly communicate M&S results.

KEY RESPONSIBILITIES:

• Independently determines, plans, executes, and interprets modeling analyses for an entire drug development program aligned with the program strategy

• Closely collaborates with the Modeling & Simulations senior director

• Represents M&S on cross-functional drug development teams, proactively advocating model-based approaches to address development challenges

• By using state of the art Modeling & Simulation methodologies strongly contribute to decision making at critical milestones based on quantitative principles in close collaboration with Biostats, Clin Pharm and other quantitative disciplines

• Represents M&S in preparation for regulatory responses and external regulatory interactions

• Represents the department in company-wide, non-scientific initiatives

• Proactively incorporates and develops approaches and methodologies based on review of relevant scientific literature

• Supervise and mentor junior scientists

• Perform population PK, PKPD-analyses, Clinical trial simulations and other model based analyses on a regular basis

• Coordinate outsourced Modeling & Simulation activities when appropriate

• Strengthen our internal Modeling & Simulation capability on a continuous basis by initiating training activities, evaluating and incorporating new M&S tools as appropriate.

• Demonstrate effective communication and leadership to a broad audience with diverse backgrounds, including senior management

PREFERRED EDUCATION AND EXPERIENCE:

• PhD in Pharmaceutics, Clinical pharmacology, or other quantitative discipline with an emphasis Pharmacometric methodologies

• Minimum of 10+ yrs of industry experience in the application of Pharmacometrics within the context of drug development.

• Expert hands-on skills from population-based PKPD modeling, Clinical trial simulation and optimal design, probability of success calculations, Disease progression modeling, Meta analyses etc.

• A solid understanding of fundamental pharmacokinetic and quantitative pharmacology (PKPD) principles.

• Excellent programming skills (NonMem, R, Phoenix, SAS and other similar tools)

• Demonstrated strong leadership and influencing skills

• Excellent collaborative, verbal and written communication skills

• Experience from Regulatory interactions and guidelines relevant for M&S

Pay Range 194,400.00 – 291,600.00 USD annually

The range provided is based on what we believe is a reasonable estimate for the base salary   pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility   and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

#LI-AR1 #LI-Remote

Pay Range:

$194,400 - $291,600

Disclosure Statem