Medical/Scientific Director, Clinical Development

Spero Therapeutics

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 05/11/2021
  • Website: sperotherapeutics.com
  • Company Address: 675 Massachusetts Avenue 14th Floor, Cambridge, MA, 02139

About Spero Therapeutics

Spero Therapeutics is developing novel therapies to treat highly resistant bacterial infections. The company is in partnership with Roche to develop its first program targeting gram-negative infections.

Job Description

About Us

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 (tebipenem pivoxil hydrobromide, formerly SPR994), is designed to be the first oral carbapenem antibiotic for use in adults to treat serious bacterial infections, including those caused by MDR Gram-negative infections. In September 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in complicated urinary tract infection and acute pyelonephritis. 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 Medical/Scientific Director, Clinical Development will provide Clinical/Medical Insight and support on the development and execution of key strategic medical initiatives for Spero’s lead program. Reporting into the Chief Medical Officer, you will partner closely with the Medical Affairs and Commercial Organizations. You will work cross-functionally as a medical and scientific expert, providing scientific and strategic insights to internal and external stakeholders.

What You’ll Do

    Serve as the subject matter expert for Tebipenem HBr, 720, and 206 as well as the competitive landscape
    Provide clinical support for external grant proposals and collaborations (BARDA, GARD-P)
    Provide scientific expertise in the review process of all portfolio wide publications and data presentations to medical conferences
    Provide insight to protocol development for Ph3B and Ph4 programs, as well as provide medical input to the tebipenem HBr Ph 4 and IIT Clinical Study Programs via member on the Research Review Committee
    Represent Tebipenem HBr, with potential to expand to responsibility to other SPR portfolio products, externally through advisory boards, conference presentations, and engagement with key stakeholders as appropriate
    Serve as medical reviewer on MAR to ensure scientific accuracy of medical and scientific material i.e. standard response documents, dossier, etc.
    Develop and maintain close working relationships with internal colleagues to ensure alignment and execution of integrated strategic priorities
    Offer clinical support for sales training
    Serve as medicolegal review of launch and promotional materials via MLR
    Supportive role for Clinical Development Efforts

What You’ll Need

    7+ years clinical experience in Infectious Disease or Critical Care, Urology, Nephrology
    7+ years of experience in the pharmaceutical industry
    Proven track record of cross-functional team leadership and successful project management
    Experience managing external vendors
    Excellent oral and written communication skills; proven track record of publication and/or scientific presentation preferred
    Ability to partner with key internal stakeholders to understand Spero’s key objectives and to drive plans that meet and exceed our goals
    Adaptable, solution-oriented and able to relate effectively with people at all levels of the organization
    Strong scientific and clinical acumen
    Current working knowledge of US legal, regulatory and compliance regulations and guidelines
    Demonstrated understanding of relevant connections and integration points between Medical Affairs and stakeholders across the clinical, commercial, and market access 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.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.