Manager, Program Management, CMC

Spero Therapeutics

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Engineering Prod Mgmt/Dev
  • Post Date: 01/19/2021
  • 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

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

 

Spero Therapeutics is looking for a highly collaborative and meticulous Program Manager to work closely with the CMC team to drive the timeline towards an NDA and other clinical and regulatory deliverables. Reporting to the Associate Director, Program Management, this role will work to convert strategic objectives into operational project plans and to meet the goals/timelines for those projects. 

 

This role will play an integral part of the Spero CMC team as we work towards an NDA submission for Tebipenem HBr.

 

What You’ll Do

  • Create detailed cross-functional CMC project plan and dashboard to track and communicate progress at a level of detail and in a format consistent with Spero standards to the appropriate stakeholders. 
  • Partner with the CMC Lead and cross-functional CMC team as we manage multiple, complex activities across Drug Substance, Drug Product, Quality, Analytical and Regulatory CMC in preparation for NDA and commercial launch of our lead product candidate, SPR994.
  • Regular tracking of CMC activities required to support NDA and approval
  • Run cross function CMC team meetings as well as key sub-team meetings and ensures that clear agendas are set, and actions and decisions are documented, communicated and committed to, enabling timeline achievement.
  • Ensuring effective communication of project deliverables up and across the organization
  • Identifying continuous improvement and lessons learned opportunities to the team
  • Utilizes effective communication skills to facilitate appropriate information exchange between Functional Lines, Development Program Leader, Core Teams and senior management.
  • Work with the CMC team to proactively identify risks and issues, and avoid/mitigate them.
  • Identify, assist with, and track action items and deliverables.
  • Develop and track budgets against program objectives.
  • With team members and in accordance with corporate objectives, facilitate the setting of program strategy and objectives, key milestones and scope.
  • Coordinate the internal assessment and approval of the Department’s development and manufacturing contracts with appropriate business partners (e.g. Legal and Finance).
  • Manage collaboration and sharing of information on team shared drives

 

What You’ll Need

  • 3-5 years of experience in CMC in Pharma or Biotech project management; with a focus on CMC Project Management  
  • BS/BA required; degree in scientific field preferred. 
  • Demonstrated experience in managing complex projects and working successfully in a diverse team.
  • Demonstrated success comprehending and communicating the big picture while also identifying and managing the details.
  • Ability to work well in a cross-functional, fast-paced team environment, build consensus and drive resolution of issues while building and maintaining positive working relationships across functions.
  • Proven ability to work collaboratively and influence without direct authority. 
  • Strong analytical and technical skills, including proficiency in project management practices, project planning, and decision-making. 
  • Skilled with Microsoft Office Suite and Microsoft Project.
  • Excellent written and presentation skills, and information management skills.

 

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.