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Associate Director Clinical Operations Program Leader

Job Post Index 23DF1A-Sy##
Location Cambridge, MA
Description: Description
  • Accountable to the GPT for the translation of the ECRP and/or CDP into an optimal operational strategy and plan.
  • Ensure assessment of various scenarios for optimal execution of the CDP.
  • Partner with the CST to develop high quality study synopsis/protocol by providing operational input and by ensuring all relevant stakeholders (both internal and external) are involved and contributing.
  • Collaborate with early or late phase COPL counterpart to ensure alignment and seamless interactions with the GPT
  • Maintain close communication with the Global Program Leader to ensure expectations and activities are aligned.
  • Develop and lead the Early or Late Phase Clinical Program Operations strategy and planning on assigned clinical programs in close collaboration with our strategic partners, other CROs, other vendors, and with the CST.
  • Perform program-level oversight of our strategic partners and other vendors to ensure the overall operational execution and delivery of the assigned clinical programs in compliance with quality standards on schedule and on budget.
  • Collaborate with cross-functional counterparts to oversee performance for all activities assigned to company strategic partners/CROs/other vendors, including escalation of issues to governance committees and senior management when warranted.
  • Responsible for clinical program budget planning and accountable for external spend related to clinical program execution.
  • Work closely with strategic partners, other vendors, Global Program Management (GPM), Outsourcing Management, and Finance to ensure on a regular basis that budgets, enrolment, and gaiting are accurate.
  • Communicate program status, cost and issues to ensure timely decision-making by senior management.
  • Provide program-level direction and support to the Associate Program Leader (APL) in the development of study strategy operational plans including enrolment models and risk management strategy.
  • Participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence.
  • Review and provide expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs),
  • Review and provide clinical operations input into clinical documents including study synopsis and protocols, clinical study reports, the New Drug Application (NDA), Marketing Authorization Application (MAA), updates to IND and NDA documents, and DSURs
  • Provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2, Request for Scientific Advice Meetings, etc.)
  • Lead in partnership with Strategic Partners/other CROs/other vendors to ensure inspection readiness.
  • Lead functional strategic initiatives and process improvement.
  • Actively seek new ways of working more efficiently to meet the needs of clinical development.
  • Act as a role model for company values.
  • Recognized as a clinical operations expert by other functions
  • Direct management, including coaching, training and performance management of more junior COPLs and APLs
  • Assist the Director/Senior Director in his/her function
  • Is a key point of contact between the strategic partners/preferred supplies and the GPT/CST.
  • Provide program and study-level direction and support to the strategic partners/preferred suppliers for the development of study strategy operational plans including enrolment models and risk management strategy.
  • Perform site feasibility/capability assessments for programs/studies requiring specialized experimental tests and/or technologies and work with TSL and sites to ensure successful operational outcomes
  • Work with Procurement and Legal to qualify new clinical vendors and, when appropriate, manage vendors for duration of a study (for vendors contracted directly with company)
  • Provide operational expertise and strategic input to the development of Early Clinical Research Plan (ECRP) and/or Clinical Development Plans (CDP) supporting the overall clinical strategy for one or more clinical programs.
  • Develop and lead the program-level operational strategy and planning on assigned programs in close collaboration with strategic partners and other vendors.
  • Provide program-level sponsor’s operational oversight of our strategic partners and other vendors to ensure the effective execution of the clinical studies on time, with high quality and within agreed budget.
  • Represent teams to lead the Clinical Sub Team (CST) accountable for the development and execution of the ECRP and/or CDP.
  • Take on functional leadership responsibilities that may include line management, providing expert consult for issue resolution and assisting the relevant Director/Senior Director
  • Providing program oversight (program-level role not study-level role); strong oversight of CRO's
  • Financial management/budget planning
Skills: Qualifications
  • Bachelors Degree or international equivalent required, Life Sciences preferred.
  • Advanced degree is highly desirable
  • Highly preferred any experience working on GI assets and/or cell therapy
  • Excellence in program management, including scenario assessment, risk assessment and contingency planning
  • Able to influence without authority
  • Excellent teamwork, organizational, interpersonal, conflict resolution and problem solving skills
  • Entrepreneurial and innovative able to take measured risks, think outside the box and challenge the status quo
  • Pragmatic and willing to drive and support change
  • Is comfortable with ambiguity
  • Able to support a culture of continual improvement and innovation; promote knowledge sharing
  • Fluent business English (oral and written communication skills)
  • 10 years experience in Pharma Industry and/or clinical research organization desired
  • 7+ years clinical study/project management.
  • Experience must include early phase clinical studies/Phase 2 studies or later phase global/international programs.
  • Experience in more than one therapeutic area is highly desired.
  • Line management experience is advantageous.
  • Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
  • Awareness of local country requirements
  • Clinical operations experience (overseeing them)
  • Clinical background.
  • Leadership/Facilitating/Collaborating skills

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