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 record of sustained external visibility through publications, presentations and/or involvement in professional organizations
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$200,200.00 - $315,100.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
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Employee Status:
RegularRelocation:
Domestic/InternationalVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/ARequired Skills:
Business Intelligence (BI), Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Software Development, Stakeholder Relationship Management, Waterfall Project ManagementPreferred Skills:
Job Posting End Date:
11/30/2024*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R311439