Executive Director, Quantitative Pharmacology and Pharmacometrics

Job description

Job Description Our company's Quantitative Pharmacology and Pharmacometrics (QP2) Department is seeking a Team Leader (Executive Director) to support our rapidly expanding immunology pipeline. Immunology has been a strategic growth area for our company during the last years including an exciting late-stage pipeline including tulisokibart and a deep emerging pipeline consisting of traditional and newer modalities. This Team Leader brings deep disease area knowledge in immunology with strategic thinking to drive model-informed decision-making in our immunology portfolio in an end-to-end manner to gain competitive advantage. The individual has a strong understanding of the quantitative pharmacology global regulatory landscape to oversee and deliver on regulatory submissions, pediatric and life-cycle management strategies with QP2 pharmacometric partners. The individual also develops translational strategies around optimal use of biomarkers and concomitant mechanistic/ QSP models to select and derisk drug candidates (including complex modalities) and drug combinations, to accelerate clinical development timelines in early and late stages of development, to demonstrate unambiguous differentiation over existing products and to implement personalized medicine, aligned with our partners. The immunology Team Leader will oversee a team of QP2 scientists, provide guidance in personnel management, scientific oversight, and operational execution, and may serve as QP2 lead on complex projects. Reporting directly to the QP2 Immunology Therapeutic Area Head and serving as their delegate when needed, the individual will collaborate closely with the QP2 Immunology leadership team and broader organization to ensure consistent, high-value quantitative pharmacology contributions throughout the Immunology portfolio from discovery through life cycle management, and create a culture of collaboration and high performance in the group. This role is also part of the extended QP2 leadership team and expected to bring leadership and active contributions to one or more business or talent facing workstreams. Primary Responsibilities: Leading a team of up to 7 QP2 scientists including people management, scientific and operational oversight, under the direction of the Therapeutic Area Head of Immunology 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 all relevant modalities, shaping the clinical pharmacology regulatory strategy for selected immunology assets, and ensuring high quality regulatory documents (INDs, CSRs, CTDs) Applies immunology knowledge and strategic thinking to identify, prioritize and develop enabling modeling platforms (disease, mechanistic, comparator models) at scale to create a differentiated immunology portfolio in an end-to-end manner in partnership with key internal/external collaborators Implements quantitative clinical pharmacology, pharmacometrics and translational modeling efforts to streamline drug discovery and development strategies and integrating knowledge to inform key decisions Engaging as an expert representative for QP2in cross-functional and governance discussions, including business development and licensing evaluations Setting priorities for direct reports and driving performance management, hiring and retention, staff development and training, and input into calibration and talent management processes In partnership with the Therapeutic Area Head of Immunology, identify resource needs and contribute to resource allocation internally Fostering a culture of collaborative and high-performing teaming Education: Ph.D./PharmD or equivalent degree with at least 12 years of experience where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or regulatory Required Experience and Skills: Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, computational biology, or a related field Immunology therapeutic area and translational science knowledge Demonstrated experience in regulatory strategies in Immunology including prior experience independently authoring and defending regulatory filings for marketing authorization (NDA/MAA) Extensive experience in developing quantitative strategies for impacting pipeline decisions across different phases, and including complex modalities Strong understanding of functional deliverables in drug R&D, with an ability to connect QP2 contributions to broader activities and needs Demonstrated ability to lead interdisciplinary teams or taskforces, and to oversee and drive results through the work of others Record of ability to operate in an inclusive and high-performance work environment applying enterprise ways of working principles including fostering collaboration and driving results, while managing ambiguity Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning Preferred Experience and Skills: Expert skills in performing mechanistic modeling and/or population PK/PKPD analyses using standard software (e.g., Mathlab, NONMEM, R, Monolix, Phoenix, etc.) Scientific understanding of biopharmaceutical and ADME properties across modalities Record of applying mechanistic models to inform decisions 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 Required Skills: Clinical Pharmacology, Immunology, Informed Decision Making, People Management, Pharmacometrics, Regulatory Submissions, Stakeholder Relationship Management, Strategic Planning Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $231,900.00 - $365,000.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term inc