Head of Clinical Operations

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Company: Forma Therapeutics
Location: Watertown, MA 02472

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Job Summary

Reporting to the Chief Medical Officer, the Head of Clinical Operations will lead operations and work with an integrated team of Clinical Operations professionals to advance the development of FORMA’s pipeline. This role will be central in establishing and having oversight responsibilities for the collaboration, effective management, and communication with multiple external partners, including global vendors and stakeholders (CROs, central labs, IRBs, and other external partners). This role will promote relationship development
both internally across functional groups, and externally with vendors, KOLs, Investigators and Study Coordinators.

The Head of Clinical Operations will oversee the operational aspects of all clinical studies worldwide through providing resources, standard processes, and strategic operational direction for clinical trial execution. This role oversees clinical trial partners and, working with internal team members, will proactively identify, manage, and communicate risks to key stakeholders, and establish solutions with the highest quality for safety and effectiveness.

Responsibilities and Duties

  • Maintain an overview of status, issues, or risks across programs to effectively communicate to all stakeholders
  • Ensure internal consistency across studies and ensures alignment of operational programs
  • Identify risks, develop/implement mitigation strategies, and escalate issues that may jeopardize timelines and deliverables
  • Identify opportunities to optimize processes and procedures
  • Support the development and implementation of global clinical operations strategy
  • Plan and identify resources for global clinical studies based on company priorities, project timelines and staff competencies
  • Centralize activities in study start-up, maintenance and close out that are common to all trials
  • Standardize adherence to global clinical standards
  • Provide expert input and guidance in system selection and implementation of emerging business technologies used during the study (e.g., EDC, IRT, CTMS, TMF)
  • Manage alliances with strategic partners, including CROs and other vendors, to ensure operational plans, timelines, and budgets are aligned with corporate objectives and standards, as well as program goals
  • Lead interdisciplinary activities by coordinating and collaborating with internal teams to set goals and timelines, formulates strategies for execution, and escalates issues that may jeopardize timelines, quality or deliverables
  • Maintain awareness of industry trends and developments to innovate and promote future strategic direction for clinical programs, studies, vendors, systems, and sites
  • Hold accountability for and participates in long-range financial planning by working with Clinical Operations staff and Finance to develop budgets, projections, accruals and track financial status against program-level budget
  • Provide operational leadership for inspection-readiness
  • Lead or participate as appropriate in process development and process improvement initiatives
  • Responsible for all operational aspects of clinical trials, ensuring compliance with GCP’s, SOPs, and standards and in compliance with FDA, EMA, GCP, and ICH guidelines

Qualifications and Skills

  • A minimum of BS Degree in science or a health-related field
  • A minimum 12+ years of direct clinical trial management experience, including operational/ project management experience
  • Team leadership and operational excellence experience
  • Line management experience preferred
  • Ability to anticipate, timely escalate issues and to define appropriate action plans
  • Ability to work cross-functionally and foster collaboration
  • Ability to work in an international environment with internal and/or external partners
  • Able to successfully communicate complex concepts and data to a variety of audiences
  • Expert knowledge of global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, local country requirements and ICH GCP
  • Registration (NDA/MAA) submission experience
  • Deep understanding of managing external relationships, specifically with investigators, advisors, other study personnel, clients and vendors
  • Ability to communicate effectively at all levels and in a highly collaborative team environment

About FORMA

FORMA Therapeutics is focused on the discovery, development and commercialization of transformative medicines that will make a difference for patients with rare hematologic diseases and cancers. A fully integrated biopharmaceutical company, FORMA’s validated, proprietary R&D engine combines deep biology insight, chemistry expertise and clinical
development capabilities to create differentiated drug candidates with best-in-class or first-in-class potential. FORMA has delivered high-value clinical candidates to its partners and generated a broad proprietary portfolio of programs, ranging from pre-clinical to pivotal-stage, with the potential to provide profound patient benefit. For more information, please visit the company website at http://www.formatherapeutics.com.