Assoc. Dir., Clinical Operations Program Leader (t282)

  • Contract Duration: 12 months, potential to convert to FTE
  • Clinical
  • Boston, MA

Website Lenox Executive Search

Description

Contract position – Remote

OBJECTIVES:
• Highly preferred any experience working on Hematology and Immunology assets.
• 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 our 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 Clinical Operations (Early or Late) at the Global Program Team (GPT) and partner with Translational Clinical Lead/Global Clinical Lead and Global Program Manager 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 functional management providing expert consult for issue resolution and assisting the relevant Director/Senior Director

ACCOUNTABILITIES:
• Accountable to the GPT for the translation of the ECRP and/or CDP into an optimal operational strategy and plan. Ensures 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 (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
• Collaborate with cross-functional counterparts to oversee the performance for all activities assigned to our strategic partners/other CROs/other vendors, including escalation of issues to governance committees and to senior management when warranted.
• Responsible for clinical program budget planning and accountable for external spend related to clinical program execution. Works 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.
• Communicates program status, cost and issues to ensure timely decision-making by senior management.
• Provide program-level direction and support to the Clinical Operations Manager (COM) in the development of study strategy operational plans including enrolment models and risk management strategy.
• May 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), study synopsis & protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), updates to IND and NDA documents, DSURs and other safety reports; Provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2, Request for Scientific Advice Meetings, etc.), as appropriate.
• 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
• May include functional management, including coaching, training and input for performance management of more junior COPLs and COMs
• Management, including coaching, training and performance management input for COM
• May assist the Director/Senior Director in his/her function, as required.
• For certain types of studies and programs, COPL may have the following responsibilities:
o Is a key point of contact between the strategic partners/preferred supplies and the GPT/CST.
o Provide program & 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.
Performs 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
o Work with Procurement & Legal to qualify new clinical vendors and, when appropriate, manage vendors for duration of a study

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education: Bachelor’s Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable
Skills:
• Demonstrated excellence in program management, including scenario assessment, risk assessment and contingency planning
• Demonstrated excellent matrix leadership and communication skills
• Able to influence without authority
• Excellent teamwork, organizational, interpersonal, conflict resolution and problem solving skills
• Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo
• Pragmatic and willing to drive and support change
• Is comfortable with ambiguity
• Support a culture of continual improvement and innovation; promote knowledge sharing
• Fluent business English (oral and written)

Experience:
10+ years’ experience in pharmaceutical industry and/or clinical research organization, including 7+ years clinical study/project managementExperience 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 but not required.
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 is also required.

Comments:

Experience in clinical operations
– More strategic than day-to-day study management (might take on a study, but that is not the core of the position)
– Will be managing program – assets or studies for the same asset
– Working mainly with CRO’s and internal functions that provide oversight of CRO’s
– Leadership of meetings
– No direct reports, functional reporting/influencing – know how to lead a team without authority
– Big picture view of the program – ability to drill down into details if necessary but mainly big picture: look at entire program from study to product launch
– Leading/facilitating/collaborating with cross-functional team
– Reporting program information to senior leadership – know what and when and how to present it
– Working in plasma-derived therapies but doesn’t need that specific prior experience

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