Director/Senior Director, CPMS - Modelling

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel is one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding in North America.

We currently have a tremendous opportunity for a Director/Senior Director, CPMS - Modelling to join this extremely collaborative and super friendly team! If you’re looking for an opportunity to expand professionally, do more than a narrow scope of work, work alongside a large team of CPMS experts, and provide solutions to a variety of clients with various products in different stages of development across multiple therapeutic areas, we would love to connect!

We're currently seeking an intellectually curious and highly innovative Pharmacometrician to bring their modelling expertise and high-level of motivation to our team and help our clients reduce the time to bring new treatments to patients.

The Director/Senior Director, CPMS - Modelling ensures the strategic application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development; provides expert consultative support for PK/PD strategy and interpretation to other SBUs and clients sets; the direction and delivery of quality services to clients; serves as a point of contact to senior members of Parexel; drives business opportunities for integrated offerings and partners effectively with business units across the company to influence Parexel's strategic direction and client facing activities.

Key Accountabilities:

Project and Program Management

• Analyze clinical PK/PD data as a member of several multidisciplinary development program teams.

• Work with clinical teams to design PK/PD components in various study designs such as first-in-human, Proof of Concept, Phase 2B, bioequivalence and drug-drug interaction studies.

• Author or contribute to clinical PK/PD sections of relevant documents.

• Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of sophisticated PK/PD modeling and simulation initiatives, including population PK/PD analyses for all phases of development

• Review scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports

• Maintain a strong working knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics

• Develop and maintain a relationship with internal and external clients and scientists

• Author clinical protocols, clinical study reports, regulatory responses and submissions and publications for peer review journals.

• Accountable for the strategic and operational delivery of client programs and projects to time lines, quality expectations and regulatory requirements.

• Drive embedding of LEAN concepts in process deployment and improvement

• Provide subject matter expertise to internal PAREXEL teams as needed

• Initiate and contribute to department and cross-BU improvement and training initiatives.

• Identify, quantify and as appropriate mitigate risks within the team driving business continuity and quality

Client Engagement and Business Development

• Initiate and maintain scientific and consultative relationships with clients contributing to strategy of client programs in CPMS

• Identify and follow through new business opportunities

• Think beyond function, business unit and geography to create new market opportunities

• Promote CPMS capability across Parexel to optimize integration in company and client initiatives.

• Oversee MSA price negotiations, e.g. rate cards and discount structures

• Accountable for the Customer Satisfaction

• Work with Marketing in the preparation and participation of webinars, symposiums, industry conferences, articles and white papers, etc.

• Review and lead preparation of Request for Information (RFI) and Request for Proposal (RFP) for potential clients

Skills:

• Excellent knowledge of PK and PD principles

• Strong experience with the design and implementation of Model-Based Drug Development strategies

• Expertise with Pharmacometric methodologies (e.g., disease modelling, conc-QT analysis, clinical trial simulation)

• Experience in Pharsight Software (WinNonlin/Phoenix)

• Experience in other software such as NONMEM, GastroPlus and R is desirable

• Significant experience in clinical drug development of both NCEs and biologicals

• Excellent interpersonal, verbal and written communication skills

• Client focused approach to work

• Significant competence in applying networking skills within Parexel and with external key opinion leaders and clients

• Proven record of developing and implementing strategies

• Uses expertise to influence change

• Demonstrated experience in identifying and adopting new technologies and techniques in support of an evolving business domain

• Ability to analyze business needs and act decisively

• Demonstrated experience and influence of strategy, design and implementation of projects and program deliverables

• Excellent problem solving, risk assessment and decision-making skills at the department and enterprise level

• Demonstrated emotional intelligence

Knowledge and Experience:

• Advanced science degree (PhD, PharmD, MSc) and/or relevant experience

• At least 7+ years post academic training experience with hands on modeling and simulation in drug development and clinical trial conduct in pharmaceutical industry, CRO, or similar life sciences consulting firm is required

• Demonstrated expert knowledge of regulatory environment as it relates to CPMS and Drug Development

Although the role does not currently have direct line management responsibilities, it offers incredible growth potential and the opportunity to build and oversee a team.

At Parexel we embrace flexibility and understand that in today’s fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, you’re exposed to a world of experiences and open doors. Apply today!

Parexel Benefits:

• Health, Vision & Dental Insurance

• Tuition Reimbursement

• Vacation/Holiday/Sick Time

• Flexible Spending & Health Savings Accounts

• Work/Life Balance

• 401(k) with Company match

• Pet Insurance

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.