Project Manager-Drug Development

3 weeks ago

South San Francisco, United States Planet Pharma Full time

Seeking a Project Manager to become an integral part of our genetic medicine drug development effort. This individual will project manage drug development programs for the teams ranging from early research through IND, BLA, and MAA. The candidate will provide project management and drug development expertise to Research, Lab Operations and Development teams as well as cross functional stakeholders. This individual will partner with the team leads in driving the operational and strategic direction to meet the overall program goals and objectives. The individual will identify and manage key project deliverables, cross functional dependencies, milestones, and track research and nonclinical timelines via dashboards to ensure accurate planning, communication, decision making, and risk management. This Project Manager will work collaboratively with internal and external cross-functional teams, collaborators, and consultants to design and efficiently execute research and development programs that support clinical development and regulatory submissions.

RESPONSIBILITIES

  • Conduct IND enabling in-vivo pre-clinical studies for multiple therapeutic programs in parallel using different animal models. Specific activities will include dose administration, in-vivo safety and efficacy parameters collection and evaluation, blood samples collection, necropsy and organs collection for subsequent testing.
  • For each program, maintain high quality standards and rigorous quality control, as well as identify best practices and areas for process improvement.
  • Document diligently on all experimental designs, protocols, data collection, and reports, supporting regulatory submissions.
  • Coordinate logistics of non-clinical study specimens, manage tissue samples collection and processing.
  • Write and review standard operating procedures (SOPs) and Analytical Methods.
  • Collaborate with the research team on the platform technology development, internal pipeline strategy, candidate selection, and external activities such as R&D partnering and academic collaborations, as well as vendor management.

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS

  • BS/BA in Biological Sciences or closely related field of study
  • 4-8 years of experience in drug development (pharma/biotech) w/ 2-3 years of project management experience
  • IND/CTA and NDA/BLA development experience
  • Demonstrated leadership and ability to work effectively with project teams.
  • Ability to build / foster cross-functional collaborations both internally & externally
  • Experience in genetic medicine drug development.

Other Qualifications

  • Ability to work in a fast-paced, team-oriented environment.
  • Strong planning and organizational skills
  • Excellent written and verbal communication skills
  • Experience in MS Project, PowerPoint, Excel, SharePoint, and Microsoft Teams
  • PMP Certification a plus

  • Director/Senior Director, Drug Product/Formulation Development

    2 weeks ago

    South San Francisco, California, United States IDEAYA Biosciences Full time

    We are seeking an experienced and highly motivated Director/Senior Director, Drug Product/Formulation Development who will report to the VP of CMC. This individual will drive the drug product development and strategy including pre-formulation, formulation, scale-up and manufacture for all our preclinical and clinical projects. The scope spans the development...

  • Senior Drug Safety Case Manager

    2 weeks ago

    South San Francisco, United States Cytokinetics, Incorporated Full time

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of...

  • Director CMC

    6 days ago

    San Francisco, United States EPM Scientific Full time

    Director of CMC Location : San Francisco, CA Working situation : Hybrid Level : Director Our client, a blooming biotechnology company, is looking to expand their R&D capacity to support their growing pipeline including a new class of brain therapies. With a passion for treating neurodegenerative and neuropsychiatric disorders, they are at the forefront of...

  • Development Project Manager

    4 days ago

    San Francisco, United States INTROLINX INC Full time

    *****Experience in eCommerce Retail industry a big plus**** The ideal candidate will have experience in successfully managing cross functional teams developing software development projects. They must have a thorough understanding of the software development lifecycle (SDLC), and some experience in various SDLCs, specifically Agile (Lean or Scrum) and...

  • Project Odyssey Manager

    3 days ago

    San Diego, United States Wounded Warrior Project Full time

    Manage a team of local and remote Project Odyssey Specialists having varying backgrounds, education, and experience. Serve as a mentor to the team, developing their skills and abilities, and supporting them as they provide programmatic multi-day and Manager, Mental Health, Project Management, Programmatic, Skills, Support, Business Services

  • Scientist, CMC Analytical Development

    1 month ago

    South San Francisco, California, United States Alumis Inc. Full time

    Alumis is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.The Alumis team is seeking a highly motivated Contract...

  • Scientist, CMC Analytical Development

    4 weeks ago

    South San Francisco, United States Alumis Inc. Full time

    Alumis is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. The Alumis team is seeking a highly motivated...

  • Project Manager

    4 weeks ago

    South San Francisco, United States Fntech Full time

    Job DescriptionJob DescriptionProject Manager FNTECHSouth San Francisco CA, USAPosition Summary:FNTECH is seeking a Project Manager with a passion for live events, audio-visual experiences, team management, and a commitment to program execution to join our Production team. The ideal candidate should have strong problem-solving skills, quantifiable leadership...

  • Supervisory Management and Program Analyst

    4 weeks ago

    San Francisco, United States Drug Enforcement Administration Full time

    Summary This position is located in the Drug Enforcement Administration (DEA), Caribbean and San Francisco Field Divisions. The position's primary purpose is to support the Business Operations Program (BOP) within the respective DEA Domestic Division. The incumbent will serve as the General Service Unit (GSU) Chief and will be responsible for managing...

  • Scientist, CMC Analytical Development

    1 month ago

    South San Francisco, United States Alumis Full time

    Job DescriptionJob DescriptionSalary: Alumis is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.The Alumis team...

  • Scientist, CMC Analytical Development

    10 hours ago

    South San Francisco, United States Alumis Full time

    Job DescriptionJob DescriptionSalary: Alumis is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.The Alumis team...

  • Sr./Project Manager

    1 month ago

    South San Francisco, California, United States Amplifybio, LLC Full time

    Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO...

  • Drug Testing Manager

    2 weeks ago

    San Antonio, United States Recovery Monitoring Solutions, LLC Full time

    Recovery Monitoring Solutions is a leading provider of treatment and offender monitoring services, with corporate offices in Dallas, TX. POSITION SUMMARY Duties include the provision of general oversight and supervision for the Drug Testing Program within local office, dissemination of information and technical assistance to local office staff and...

  • Drug Testing Manager

    2 weeks ago

    San Antonio, United States Recovery Monitoring Solutions LLC Full time

    Job DescriptionJob DescriptionRecovery Monitoring Solutions is a leading provider of treatment and offender monitoring services, with corporate offices in Dallas, TX.POSITION SUMMARYDuties include the provision of general oversight and supervision for the Drug Testing Program within local office, dissemination of information and technical assistance to local...

  • Associate, Project Development

    2 weeks ago

    San Francisco, United States Clearway Energy Full time

    What The Role Is Reporting to the Director, Project Development, the Associate, Project Development is responsible for both supporting and directly managing the development of projects across the West region of the U.S. The Associate will be a key member of the regional team that is charged with the development and execution into the construction of Clearway...

  • Project Controls Manager

    6 days ago

    South Bend, United States Tri-City Electric Co. Full time

    Tri-City Electric Co. is currently seeking a Project Controls Manager for an immediate opening in South Bend, IN. The Project Controls Manager will support the project management team in successful delivery of projects, develop budgets, monitor, and report to external stakeholders on progress and forecast successfully. Responsibilities include but are not...

  • Project Manager Construction

    4 weeks ago

    San Fernando, United States BrightView Landscape Development Full time

    Description Position at BrightView Landscape Development At BrightView, the best teams are created and maintained here. If you are searching for your next fulfilling career, picture yourself on a best-in-class team where you can grow to be your brightest. We're looking for a Project Manager Construction. Can you picture yourself here? Here's what you'd do:...

  • General Manager

    3 days ago

    South San Francisco, United States Amoura Development Company Inc Full time

    Job DescriptionJob DescriptionSummary: Amoura, a Michelin and Zagat rated fine-casual restaurant in South San Francisco, is a family run business serving Mediterranean food with a twist.We are looking for an amazing Restaurant Manager to represent our family overseeing the restaurant in an efficient, professional manner according to high standards by...

  • General Manager

    2 days ago

    South San Francisco, United States Amoura Development Company Inc Full time

    Job DescriptionJob DescriptionSummary: Amoura, a Michelin and Zagat rated fine-casual restaurant in South San Francisco, is a family run business serving Mediterranean food with a twist.We are looking for an amazing Restaurant Manager to represent our family overseeing the restaurant in an efficient, professional manner according to high standards by...

  • Technical Project Manager

    4 weeks ago

    San Francisco, United States Zenith Services Full time

    Our client is looking for a Technical Project Manager for a long term project in San Francisco, CA. **Job Function Summary**: **Knowledge, Skills and Abilities** - Requires advanced knowledge of project management principles, theories, and concepts. - Working knowledge of technology-related initiatives and an understanding of impact to the organization of...