Clinical Development Project Manager

We are looking for a Project Manager to be part of the IGM Biosciences Clinical Research & Development team.  In this key role, you’ll manage projects across a broad range of areas, initially, primarily early clinical development studies in oncology. You will be responsible for delivering the project on time, within budget and meeting the strategic business, strategic and technical requirements, and you’ll consult with management on an ongoing basis to maintain a strategic link to our business needs.

Responsibilities:

  • Responsible for projects and/or program deliverables on behalf of the whole team
  • Drives efficient team meetings with stakeholders including creating agendas, documenting and distributing minutes (including risks and mitigation log, issues and actions log and decisions log)
  • Proactively identify potential program level risks and develop mitigation strategies to address risks
  • Represent the organization as the prime project contact and interact with internal stakeholders and external partners on significant technical matters often requiring coordination between individuals and groups
  • Ensure complex project decisions are made with stakeholder input and discussion and utilizing good single-decision maker model
  • Design and implement new processes by operating as the subject matter expert
  • Communicate appropriate information (complexities, strategies, issues, solutions) within the organization
  • Create partnerships and take responsibility for building effective and high performing teams
  • Guide and influence teams, committees or other forum decision-making bodies and foster a collaborative team environment that excels at leveraging diversity of thinking, innovation and expertise
  • Responsible for the stewardship of multiple projects, programs and respective teams.  Key influencer in decisions, solutions and issues resolution within projects and programs
  • Determine methods and procedures on new assignments and coordinate the activities of others as a team lead. Help define and operate functional solutions to achieve value delivery and business objectives
  • Accountable for managing competing priorities, resources and activities within and across multiple projects and programs
  • Lead, develop, and proactively manage and maintain execution of high quality cross-functional project development plans with detailed timelines and budgets and monitor progress of team in meeting objectives and deliverables.

Qualifications:

  • BA or BS degree and a minimum of 5 to 7 years of leading projects in the pharmaceutical/biotechnology, or healthcare industry
  • Proven track record and complete/full understanding and demonstrated abilities in project management skills and other related disciplines
  • Post-grad coursework is desirable
  • Certified ScrumMaster and PMP Certification is preferable
  • Have successfully led large-scale early clinical development projects (with multiple tracks of work and teams in multiple locations) from concept to delivery
  • Minimum of 3 years of vendor management including strong understanding of business process and operations needed for success and negotiation experience
  • Strong skills in leading teams, problem solving, influencing, teamwork, initiative and communication
  • Demonstrated skills in innovation and creative approaches in building new business process solutions
  • Ability to work flexible hours as needed
  • Experience with T cell engagers, synthetic immunity, cancer immunotherapy and antibody-based therapeutics is preferred

IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

 

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Clinical Scientist

We are seeking an experienced clinical scientist to successfully strategize and execute a clinical development plan for engineered IgM-based pipeline molecules, starting from First in Human Phase I studies, primarily conducted in the U.S and primarily in Oncology indications.

Qualifications:

  • Advanced scientific or clinical degree (eg PhD, PharmD, MPH, MD, etc).
  • 5 or more years clinical trial experience (must demonstrate a minimum of 2 years clinical trial experience in pharma/biotech industry).
  • Data listing review experience is preferred.
  • Experience authoring experimental protocols and/or study results and conclusions.
  • Relevant therapeutic area experience.
  • In-depth understanding of Phase I (and beyond) drug development.
  • Experience in the principles and techniques of data analysis, interpretation.
  • Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations.
  • Proven abilities to perform Clinical Scientist responsibilities with increasing expertise and independence.
  • Track record of working well with other scientists and clinicians is highly valued.
  • Must be able to commute to Mountain View.
  • Able to travel (<20%).

Responsibilities:

  • Participate in Development teams, and clinical trial teams.
  • Work with Clinical Development, Clinical Operations, Drug Safety, Biostatistics, Regulatory, and Biomarker groups.
  • Develop clinical strategies.
  • Lead clinical trial protocol development, and amendments.
  • Literature research and review in disease/program area.
  • Assist with completion and submission of regulatory filings and other regulatory documentation.
  • Work with clinical teams on study site visits, and protocol training.
  • Contribute to Investigator Meetings, and Investigator/study calls.
  • Work with Clinical Operations and Medical Directors to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol dose modification, protocol safety, Case Report Forms (CRFs), CRF instructions, etc.
  • Assist with Medical monitoring inquiries, and participates in safety meetings and tracks, analyzes and reports any potential safety events.
  • Work with Medical Directors, Clinical Operations, Biostatistics, and other groups to conduct clinical review of study data.
  • Review, analyze, and discuss clinical study reporting documents with Medical Directors.
  • Slide deck preparation for communicating clinical development plans, clinical trial timelines, clinical data.
  • Support Medical Directors in preparing for internal/external meetings and presentations
  • Drafting and/or reviews of abstracts, posters, and coordinates further reviews with internal partners and stakeholders.

IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

 
 
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