Spero Therapeutics Senior Scientist, Clinical Pharmacology in Cambridge, Massachusetts
Spero Therapeutics (Nasdaq: SPRO) is a multi-asset clinical stage biopharmaceutical company in Cambridge, Mass. We are highly committed to advancing novel treatment approaches for bacterial infections with a world-class team of biotechnological and biopharmaceutical experts. The company has a pipeline of novel and highly differentiated antibacterial and rare disease product candidates focused on the unmet needs of patients with multi-drug resistant (MDR) bacterial infections. Spero?s lead product candidate, Tebipenem HBr, is an oral carbapenem currently being evaluated in a pivotal Phase 3 clinical trial for the treatment of complicated urinary tract infections. Spero is also advancing SPR720, its oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease, a rare orphan disease. Spero?s third product candidate, SPR206, is an IV-administered agent being developed as an innovative option to treat MDR Gram-negative bacterial infections.
We sincerely believe that our novel product candidates will have meaningful impact on patient health and significant commercial applications for the treatment of MDR infections in both the hospital and community settings.
General Scope and Summary of Role
The Senior Clinical Pharmacologist is responsible for clinical pharmacology, pharmacometric and PK-PD deliverables for clinical development (phase I-III) of Spero assets. The individual serves as Clinical Pharmacology Lead for development programs and will collaborate across departments for advancing projects.
This individual will report to Senior Director, Clinical Pharmacology, DMPK and Bioanalysis with assigned responsibility to support Spero Projects. This individual will provide strategic guidance for the development programs starting from phase 1 and together with clinical operations and the project team leaders will be responsible for delivering clinical pharmacology studies to agreed timelines and budget.
What You?ll Do
Develop clinical pharmacology plan, first in human dose selection and prediction using PK and PK-PD modeling.
Design, execution and delivery of clinical pharmacology, and pharmacokinetic-pharmacodynamic (PK-PD) studies.
Serve as clinical pharmacology representative across studies, attend study team meetings and be the in-house subject matter expert on all aspects of clinical pharmacology.
Collaborate across departments and CROs to drive clinical pharmacology studies and high-quality clinical study reports completion.
Work with nonclinical toxicology colleagues to determine starting dose for first in man (FIM) studies.
Preparation of clinical pharmacology documents/sections as required for submission of the IND, NDA, and/or MAA.
Support regulatory responses related to clinical pharmacology and PK-PD.
Evaluate various clinical pharmacology and pharmacometric strategies, identify suitable vendors when needed and help build in house clinical pharmacology infrastructure.
Stay up-to-date with current clinical pharmacology principles, regulatory guidance and PK-PD methodologies.
Publish manuscripts and posters, presents at scientific conferences, and other scientific forums.
What You?ll Need
PhD degree or master?s degree in clinical pharmacology, pharmacy, biomedical engineering, or a related field.
3 years (Ph.D.) or 5 years (M.Sc.) experience working as a clinical pharmacologist (small molecules), in the pharmaceutical industry.
Hands on expertise with Phoenix WinNonlin in non-compartmental PK analysis, compartmental PK modeling and simulations.
Knowledge and some experience in population PK and PK/PD modeling. Hands on experience is preferable but not necessary.
Knowledge of R, SAS and/or NONMEM is preferable but not necessary.
Prior experience in the submission of IND, and/or MAA documents.
Excellent oral and written communication skills as evidenced by presentations at scientific meetings and publications in peer-reviewed journals.
Willingness to challenge current paradigms and create new clinical and regulatory pathways to antibiotic approval and commercialization.
Team player, self-starter, professional integrity and commitment to excellence.
Effective at building alliances across functions.
By joining our committed and highly motivated team, you will experience a workplace culture that is inclusive, fair, challenging, supportive, and respectful. Spero?s culture is one that emphasizes ?servant leadership,? or putting ego aside and working for the benefit of the team and our patients and values our colleagues? opinions and celebrates accomplishments in service of patients.