Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Scientific Director, Discovery PK/PD and Translational Pharmacometrics, located in Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The Senior Scientific Director will serve as a senior consultant and sit on the leadership team of the department of Biologics Development Sciences (BDS) and report to its head, Vice President. BDS drives the discovery and development of biologic therapeutics as well as in-licensed or acquired assets pertaining to all of Janssen’s Therapeutic Areas, from early discovery through NME declaration. BDS is contributes to the preclinical development of monoclonal antibodies and novel biologic product formats such as bispecifics and T-cell redirectors, half-life extended peptides and proteins, gene therapy, oncolytic viruses, and CAR-T products.
The Senior Scientific Director will provide strategic and scientific mentorship pertaining to biologics discovery to a team of 15 scientists to successfully provide deliverables of translational pharmacology and model-guided drug design, working in close collaboration with discovery and development leaders. Whereas initially the Senior Scientific Director will have no direct reports, meeting or exceeding scientific competence expectations of this position can lead to operational team management and talent development duties. Scope of responsibility includes review and approval of data analyses from discovery studies, preclinical non-GLP studies, preclinical PK/PD and exploratory research, review and incorporation of relevant in vitro and ex vivo laboratory data from collaborators leading to systems biology, mechanistic and quantitative models for projecting first-in-human starting dose and efficacious dose range.
He/she will be expected to collaborate with key organizational partners (preclinical development PK/PD, nonclinical safety, clinical pharmacology, project management, etc) to drive the projection of human therapeutic window to drive the success of pharmacokinetic/pharmacodynamic assessments as well as inform the discovery pipeline. The Senior Scientific Director will be responsible for the preparation and review/approval of discovery relevant sections of regulatory documents submitted to regulatory authorities, and impactful manuscripts for publication.
- Provide intellectual and strategic input into large molecule drug discovery and early development, including but not limited to, study design and data analysis plans, preclinical and first-in-human (FIH) study protocols, bioanalytical strategies, and reports.
- Responsible for the scientific leadership in the conduct of pharmacokinetic (PK) and pharmacodynamic (PD) analyses and interpretation of data derived from preclinical studies, including in vitro and ex vivo experiments, toxicokinetic studies, and efficacy studies
- Responsible for the reverse translation from clinical studies and literature to improve preclinical knowledge and pharmacometric models to inform the discovery of new molecules, with utmost attention on evidence-based rational drug development
- Responsible for crafting necessary experimental studies to predict starting dose and efficacious dose in FIH studies, and collaborate with nonclinical safety colleagues to estimate/extrapolate the therapeutic window
- Perform and guide team members on external due diligence assignments
- Training and mentoring staff on effective presentations and reaching drug development outcomes successfully
- Communicate effectively with the project teams and stakeholder leadership within Janssen R&D, and with different line functions within BDS
- Evaluate and prioritize projects effectively, through delegation and resource allocation, to accomplish departmental and company objectives
- Serve as a JBIO representative on one therapeutic area related Discovery Portfolio Committee (DPC).
- Responsible for the preparation of the preclinical pharmacology section of regulatory submission documents
- Expertise in modeling software including NONMEM, Monolix, Matlab, and R
- Education: Ph.D or Pharm D., with 12+ years business experience in the pharmaceutical/biotechnology industry, and 3-5 years of experience performing progressively advanced duties at the director, or equivalent, level
- Proven track record in leading a scientific team(s) and direct and/or indirect people management experience; Strong collaborative skills and ability to influence
- Possesses a leadership position in a scientific discipline (or disciplines) as recognized externally as an expert in the preclinical or clinical pharmacometrics area.
- Published expertise with quantitative systems pharmacology highly preferred.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC (6084)