Clinical Program Manager

  • Full-time

Company Description

Altesa Biosciences, Inc is a biopharmaceutical company based in Atlanta, GA focused on developing and commercializing novel anti-viral drugs against common respiratory viruses and global viral threats. Altesa has a formal partnership with Drug Innovation Ventures at Emory (DRIVE), a wholly-owned, not-for-profit drug discovery entity within Emory University. That collaboration includes a license to ALT-2023, a broadly active nucleoside analogue that is late-stage preclinical development, as well as options to additional compounds addressing RNA viruses. Altesa has also in-licensed Vapendavir, a Phase 2 antiviral broadly active against enteroviruses, including rhinovirus, that is currently in development for COPD patients.

Altesa Biosciences is led by its CEO, Brett P. Giroir, MD, former Assistant Secretary for Health and Acting FDA Commissioner; and a highly successful and experienced management team advised by world leaders in science and clinical medicine.

The Altesa Scientific Advisory Board (SAB) is comprised of academic and industry leaders in pulmonology, infectious diseases, virology, pediatrics and drug development, and s chaired by George Painter, Ph.D., Professor, Department of Pharmacology and Chemical Biology at the Emory University School of Medicine, and President and CEO of both DRIVE and the Emory Institute for Drug Development.

Job Description

Altesa BioSciences is searching for a Clinical Program Manager to join the team.

This is a remote job opportunity for a candidate in the metro-Atlanta or DC area.

  • Responsible for integrating inputs across all development functions (ie, nonclinical, clinical, regulatory, CMC, etc.) to ensure a comprehensive, integrated development plan for one or more assets with primary focus on lead clinical asset
  • Establish robust project plans to deliver priority objectives, clearly define the critical path and decision criteria
  • Translate proposed strategies into operational plans, including timelines, budgets, and resource requirements; highlight key milestones and any potential risks
  • Ensure consistency and coordination across functions, including aligning timelines and connecting elements of the development plan to one another
  • Ensure that high operational standards are maintained across programs and drive operational excellence activities, including program and trial metrics, communication platforms, and process improvement initiatives
  • Understand business priorities/challenges and champion delivery of meaningful outputs that help drive overall strategy.
  • Maintain a common share-point / MS Team site ensuring documents are catalogued, easy to find, and up to date. Publish accurate minutes of meetings including key decisions, next steps, accountabilities and timing.
  • Monitor and manage progress against the approved schedule and budget
  • Facilitate the identification of program issues for discussion with executive leadership and bring forward options for resolution
  • Lead the team in the preparation, implementation, and maintenance of integrated risk management plan
  • Reinforces and supports team operating principles, best practices and cross-functional process efficiencies to ensure effective and high-performing teams
  • Work with external partners to help drive timelines and ensure quality deliverables
  • Provide guidance and support for individual functions, where needed
  • Proactively communicate when risks, delays, or other issues arise

Qualifications

  • Education: Bachelor’s Degree is required with advanced degree (M.S. or Ph.D.) a plus. Highly prefer candidate with a Science degree. 
  • Minimum of 5 years of relevant program management experience in the pharmaceutical or biotech
  • Familiarity with ICH and FDA guidance, GCP, GLP, and GMP
  • Specific project management training or certification (PMP) within the Pharmaceutical industry not required but desirable.
  • Demonstrated program management expertise and experience with understanding of project management methodology, software and tools.
  • Drug development knowledge across a broad range of functions and therapeutic areas
  • Strong leadership skills; excellent interpersonal and relationship management skills.
  • Strong organizational skills
  • Natural collaborator who enjoys working on a cross-functional team
  • Demonstrated ability to integrate information to build and implement solutions to organizational problems
  • Able to pivot based on shifting priorities and balance multiple projects seamlessly in a fast-paced environment
  • Self-motivated, able to multi-task and prioritize
  • Limited domestic travel may be required

Additional Information

Altesa Biosciences 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 law

 

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