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Senior Program Manager / Associate Director, Cmc Program Management

Synthekine

Menlo Park, CA, US
  • Job Type: Full-Time
  • Function: Product Mangement
  • Industry: Biotechnology
  • Post Date: 11/22/2022
  • Website: synthekine.com
  • Company Address: 1505 Obrien Drive, Suite A/D, Menlo Park, California 94025, US

About Synthekine

Synthekine is an engineered cytokine therapeutics company developing disease-optimized treatments. The company uses immunological insights to guide targeted protein engineering to generate transformative medicines for cancer and autoimmune disorders.

Job Description

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:
An ideal candidate will ensure the smooth operation of several of the Company’s pre-clinical product development programs and drive delivery of the project goals. Responsibilities include overseeing the pre-clinical pipeline programs and related project management activities (managing scope, time, cost and quality), cross-functional integration as well as ensuring that key project milestones are defined and met and that appropriate communications occur with stakeholders across functions and/or external partners. The candidate should have commensurate experience in the biotechnology industry to understand the pre-clinical and IND drug development process in biologics or cell therapy, and be skilled in the use of Project Management tools such as Smartsheet, SharePoint sites, etc. Experience working on cross-functional teams is highly desired as well as an understanding of facilitating high functioning teams.

Key Responsibilities:

  • Manage timeline, cost, risks and cross function integration for pre-clinical-stage program (s) up to IND Filing and transition to clinical PM
  • Develop and drive operational strategies for cross-functional project teams
  • Plan and execute fully integrated program plans (Pre-Candidate Nomination to IND) for development of cell therapy programs.
  • Establish clear scope of work and lead the delivery of project milestones on time and within scope through utilization of project management standards.
  • Co-ordinate and track status of cross-functional communication and integration activities.
  • Proactively anticipate issues, challenges, and assumptions as well as identify contingencies or opportunities to circumvent potential delays. Follow-up on assignments and report progress to the team.
  • Establish project team framework for Translational science, analytical and CMC teams and help define team charters, roles and responsibilities and key deliverables for each team.
  • Manage vendors to ensure timely fulfillment of commitments to meet regulatory and commercial deadlines.
  • Lead the planning and execution of risk management, resource allocation, and training.
  • Facilitate problem-solving, contingency planning, and decision-making.
  • Build and maintain effective teams: motivate, recognize, coach and mentor team members.

Qualifications:

  • Minimum BS in Biological Sciences, Bioengineering, Chemistry or an associated discipline. Masters or PhD preferred.
  • 5+ years of biotechnology or drug development experience. Gene or cell therapy experience a plus.
  • Track record of leading and advancing projects from Discovery into Clinic including experience with IND filings.
  • Experience in CMO and CRO management, regulatory requirements, and commercial development.

Knowledge, Skills and Abilities:

  • Project management experience and/or PMP certification.
  • Working knowledge of US and European regulatory requirements.
  • Outstanding organizational skills.
  • Excellent written and oral communication skills.
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment.

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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