Senior Director, Pharmacometrics

4 weeks ago

secunderabad, India Certara Full time
Overview

About Certara

Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.

The Sr. Director, Consulting Services will play a pivotal part in the growth and continuous improvement of Certara’s pharmacometrics organization (QSS – Quantitative Science Services) to achieve its strategic and business objectives, through a continued focus on achieving optimal impact in all client engagements. As a member of the QSS lead team, you will help drive critical efforts in areas including targeted recruitment of new talent, optimizing resource allocation to PMx projects, and strengthening consultant skills across the team. You will be working closely with the Global Lead of QSS to determine and implement strategies for optimization of the business processes across the team, interfacing with the Commercial & Operations teams within IDD, and promoting an environment of collaboration across CDDS and across Certara business units. Additionally, you will have the opportunity to mentor colleagues, either directly or through work product review, contribute to business development efforts and lead projects for key clients.


Responsibilities

Project lead for some operationally more complex projects (e.g. larger FTE engagements). Can include hands-on contributions to select projects. Senior resource for project teams for review of work product, discussion of project and/or client engagement strategy.

Coordinate QSS leadership meetings; drive agenda, monitor follow up, optimize meeting cadence and meeting attendees as needed. Drive optimization of resource allocation to PMx projects – develop robust yet nimble resourcing approach. Be point person for resource allocation issues across QSS. Partner with Operations team to identify individuals or teams that are under or over utilized and apply solutions resulting in balanced utilization across teams. Support the IDD Operations team with the implementation and optimization of operational processes within QSS. Coordinate recruitment for QSS – ensure that hiring targets are met, yet organizational balance (senior vs junior, distribution of skills sets) is maintained. Lead special projects that are aimed at strengthening the global footprint and effectiveness of QSS consultancy operations Be the point person for business development team to identify SMEs for scoping calls.

Business mentor for QSS team:

Foster further adoption of key consultant skills across QSS team, e.g. by contributing to the development of targeted training for PMx consultants (which could be included in onboarding), participation in project team meetings or 1:1 mentoring Contribute to development of more complex Scopes of Work. Participate in contract negotiations for more challenging contracts. Work with Business Development to strengthen the portfolio of services that we provide and how we sell these to our clients
Qualifications

Education, Experience, Training, and Knowledge:

PhD, MD, PharmD in Pharmaceutical Sciences, Pharmacology, Toxicology, Statistics, Mathematics, or related fields. A minimum of 10 years of industry/consulting experience (may be combined with academic research) working in R&D, pre-clinical and clinical environments. Good understanding of a range of multiple modeling and simulation techniques (e.g. PopPK, PKPD, MBMA, statistical modeling) and multiple TA’s. Experience in moving compounds through the different phases of development and experience with various elements of clinical development clinical trial design and conduct and regulatory filings. Demonstrated skills and experience in pharmacometrics, clinical pharmacology, pharmacokinetics and pharmacodynamics in a project team setting (including leadership roles), with clients as well as internal staff. Experience in direct interactions with regulatory agencies is a plus. Strong understanding of key success factors for a pharmacometrics consultancy enterprise Experience in the development and effective utilization of business metrics in a consultancy setting. Strong understanding of business strategy and offerings with ability to drive the development of the more complex project proposals and contribute to business development efforts. Comfortable in a client environment, well versed in communicating and collaborating with client scientists and key decision makers. Ability to identify new business development opportunities through client interactions. Proven ability to lead company initiatives. Demonstrated effectiveness in mentoring others. Excellent writing, editing, verbal communication in English. Excellent interpersonal skills.

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

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