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Director/Sr. Director, Development Project Leader (RDN17-06)

Watertown, MA

 

Job Summary

FORMA is seeking as highly qualified Development Project Leader. The successful candidate for this position will lead the strategic development of projects in the IND enabling and early development space. The Development Project Leader is responsible for leading and enabling their teams to generate and implement the overall development strategy and plan for the project to meet aggressive forward-looking goals. This position requires a high degree of leadership, teamwork and a broad knowledge of all aspects of development, including: clinical, CMC, regulatory, non-clinical development and the IND enabling process. This position reports to the head of Preclinical and Early Development

Roles and Responsibilities

  • Overall strategic leader for product development/early development projects. Set the overall vision and direction for the project and serve as visible project champion and focal point for critical project information.
  • Responsible for ensuring that the team and Project Management deliver and effectively execute on an integrated development strategy and plan, ensuring alignment across functions both within FORMA and with our collaboration partners.
    • Set and maintain focus on overall project objectives and
    • Brings proactive approach to issue Identification and Resolution
    • Drives to clear and aligned decisions within team
    • Contributes to the FORMA portfolio planning process on behalf of the project(s) they lead
    • Owns and advocates for budget and resource needs for Project
  • Develops and leads an integrated Project Team
    • Define and articulate clear strategic vision within project teams
    • Effectively integrates across functions and stakeholders. Leads a core team, and ensures the engagement and input from sub-teams to support the advancement of the project’s objectives and deliverables
  • Sets clear and accountable goals for project and team members. Ensure project deliverables are aligned with departmental objectives and corporate strategy
  • Responsible for ensuring cross-functional coordination and communication including with senior management and with partners to keep all stakeholders appraised of progress and engaged in issue resolution.

Experience, Education and Specialized Knowledge and Skills

  • PhD and/or MD with 10+ years of multi-disciplinary experience in the biotech/pharmaceutical industry with 8+ years of direct experience in drug development from IND through late-stage development (Ph1-Ph3)
    • Direct and demonstrated experience in advancing oncology therapeutics through development is required.
    • Experience in leading projects through IND filing and early development is required. Experience in NDA filings is preferred.
    • Experience in non-oncology therapy areas is an upside.
    • Demonstrated understanding and experience integrating across the entire development spectrum, including clinical, CMC, non-clinical development, regulatory and IND enabling. Knowledge of marketing and product commercialization is a plus.
  • Must thrive in a fast paced innovative environment while remaining flexible, proactive, resourceful and efficient.
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, within and beyond their team, including with management and external stakeholders.
  • Demonstrated ability to focus on the goal and a strong ability to analyze complex issues and drive to timely, thoughtful and realistic solutions and recommendations.
  • Experience with and knowledgeable of FDA, EMA and ICH regulations, industry standards and quality control principles.
  • Capable of leading multiple projects simultaneously.
  • Possesses strong written and verbal communication skills, ands ability to teach and mentor others in their team.

About FORMA

FORMA Therapeutics’ scientists are passionate about discovering and developing medicines that will make a difference in oncology, inflammation & immunity, and other serious diseases. The Company’s fully integrated R&D team drives discovery and early clinical development of therapeutics for qualified targets in the areas of epigenetics, protein homeostasis and metabolism. Leveraging a world class network of academic investigators, clinical experts and partners, FORMA combines deep biology insight, chemistry expertise and early clinical development capabilities, to create drug candidates providing profound patient benefit.

FORMA is headquartered in Watertown, MA near the epicenter of the Cambridge Life Sciences cluster, with additional chemistry operations in Branford, CT. Check us out at www.formatherapeutics.com or follow us on @FORMAInc

Please send resumes to careers@formatherapeutics.com and reference job code # (RDN17-06) in the subject line.

No phone calls please. Resumes from third party vendors will not be accepted.