Spero Therapeutics (Nasdaq: SPRO) is a multi-asset pre-commercial stage biopharmaceutical company in Cambridge, Mass. We are highly committed to advancing novel treatment approaches for bacterial infections with a world-class team of biotech and drug development experts. The company has a pipeline of novel and highly differentiated antibacterial and rare disease product candidates focused on patients with unmet need associated with multi-drug resistant (MDR) bacterial infections. Spero’s lead product candidate, SPR720, is an oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease, a rare orphan disease.  Spero’s partnership directed programs consist of SPR206 and tebipenem HBr. SPR206, is an IV-administered agent being developed as an innovative option to treat MDR Gram-negative bacterial infections and tebipenem HBr, is an oral carbapenem being developed as the first oral carbapenem antibiotic for use in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). In September 2022, Spero announced an exclusive license agreement with GSK for worldwide rights of tebipenem HBr, except for Japan and certain Asian countries.
 
We believe that our novel product candidates will have a meaningful impact on patient health and significant commercial applications for treating MDR infections in hospitals and community settings.

The Senior Director, DMPK, Bioanalysis, and Clinical Pharmacology, will report to the SVP, Clinical Development, with assigned responsibility to provide support to the Project Team Leaders. This individual will provide strategic guidance for the Phase 1 development programs and with Clinical Operations and the Project Team Leaders will be accountable for delivering clinical studies to agreed timelines and budget. This individual will supervise other Clinical Pharmacology, DMPK, and/or Bioanalysis consultants to ensure timely delivery of studies and documents.

The Senior Director, DMPK, Bioanalysis, and Clinical Pharmacology, will have cross-project responsibility for the following deliverables:

 

• The design and execution of clinical DMPK, ADME, and pharmacodynamic studies; analysis and interpretation of study results, and recommendations based on study results


• The development of bioanalytical methods to support preclinical and clinical studies


• Pharmacokinetic/pharmacodynamic modeling to support dose selection for clinical studies


• In collaboration with Toxicology, assessment of safety margins with respect to the safe starting dose, predicted therapeutic dose, and maximum allowed dose for clinical studies


• In collaboration with the Study Physician and Clinical Operations, design of the first-in-human dose escalation study and subsequent Phase 1 studies


• In collaboration with the study team, oversight of ongoing clinical studies


• Work with vendors/CROs in collaboration with Clinical Microbiology to deliver Population PK modeling, PK-PD modeling and simulations analyses for regulatory submission and therapeutic dose justification


• Preparation of Clinical Pharmacology documentation as required for submission of the IND, NDA, and/or MAA, and support of regulatory responses related to clinical pharmacology and pharmacometrics

 

• PhD degree or equivalent in a relevant discipline


• At least 10-15 years of prior work experience in an academic or industrial setting focused on the discovery and development of drugs; experience in anti-infective agents is preferrable


• Prior experience at the Associate Director/Director level including the successful delivery of a Phase 1 clinical study program.


• Expertise in population PK and PK/PD modeling


• Prior experience in the submission of IND, NDA, and/or MAA documents


• Excellent oral and written communication skills as evidenced by presentations at scientific meetings and timely publication of results in peer-reviewed journals


• Willingness to challenge current paradigms and support new clinical and regulatory pathways to antibiotic approval and commercialization

By joining our committed and highly motivated team, you’ll 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. Spero requires all employees to be vaccinated against COVID-19 absent a bona fide medical reason or genuine religious belief relating to vaccinations. All employees must be in compliance with Spero Therapeutics’ COVID-19 vaccine policy prior to the commencement of their employment. Spero Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.