Senior Director, IDVAX, Quantitative Pharmacology and Pharmacometrics (Hybrid)

Job Description

Therapeutic area Senior Directors in Quantitative Pharmacology and Pharmacometrics (QP2) are responsible for driving integrated end-to-end discovery through development portfolio decisions for multiple disease areas within a therapeutic area and for the performance, talent and resource management of their team. This role oversees an extensive portfolio in the infectious disease and vaccines therapeutic areas (IDVAX) that has experienced significant growth in the pipeline and includes multiple assets moving through near-term late development milestones. The IDVAX Senior Director is responsible for driving the portfolio forward leveraging the full strength of the QP2 department while also being responsible for talent development and staff performance management.  In addition, Senior Directors represent QP2 and provide critical strategic input on cross-functional committees and task forces, with leadership and active contributions to one or more business or talent facing workstreams. They are recognized as emerging external scientific thought leaders that develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of small molecules, biologics and novel modalities, and inform dose selection and go/no-go decisions.

As the Senior Director for the IDVAX therapeutic area, you will be responsible for providing strategic leadership and talent management for the department through:

• Leading a team of 7-10 QP2 scientists including people management, scientific and operational oversight, under the direction of the Executive Director of Infectious Disease and Vaccines

• Leveraging end-to-end drug discovery/development and disease area expertise to independently provide day-to-day scientific oversight to individual contributors

• Maintaining a comprehensive understanding of global regulatory expectations for small molecules, biologics and novel modalities, authoring and reviewing regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings

• Setting priorities for direct reports and driving performance management, hiring and retention, staff development and training, and input into calibration and talent management processes

• Identifying resource needs and contributes to resource allocation internally and through management of business operations including travel and outsourcing budgets

• Working with QP2 leadership to contribute to the development and execution of departmental priorities and ensure broad alignment of individual priorities/performance of team with the QP2 vision/mission

• Participating or overseeing due diligence reviews in the IDVAX therapeutic area

• Providing functional representation on committees, task forces or initiatives spanning beyond QP2

The Senior Director is an experienced quantitative drug developer and people manager, with a strong, integrated understanding of the strategic elements of drug discovery and development. She/he develops strategies for quantitative analyses (and commensurate experiments/trials) within and across discovery and development programs in the cardiovascular and metabolic disease therapeutic area.  In addition to the responsibilities described above, Senior Directors demonstrate outstanding leadership and communication skills collaborating across QP2 and with other functional areas, as well as with external vendors and partners to create a quantitative model-informed approach to impact program strategies and decision making on drug development teams.

Required:

• Ph.D. or equivalent degree with at least 10 years of discovery, drug development and/or regulatory experience

• Demonstrated track record in establishing an inclusive and high-performance work environment through building talent, fostering collaboration and driving results while managing through ambiguity, including at least 5 years of management experience

• Extensive experience in developing quantitative strategies for impacting pipeline decisions, and drug development expertise in ID and/or VAX

• Direct experience in regulatory interactions and filings

Preferred:

• Expert skills in performing population PK/PKPD analyses using standard pharmacometrics software (e.g. NONMEM, R, Monolix, Phoenix, etc.)

• Advanced scientific understanding of biopharmaceutical and ADME properties across modalities

• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning, with a demonstrated ability to participate in and lead interdisciplinary teams

• Recognized leader in the field of quantitative pharmacology with a track recor