Website Lenox Executive Search
Remote 6+ month extendable contract role with high potential to convert to permanent. Remote for contract period, but hybrid onsite if converted to permanent – candidate would need to be local, relocate, or pay for their own travel if converted. Neuroscience therapeutic experience highly preferred.
Lenox Executive Search is seeking an experienced AD, Clinical Operations Program Leader to fill an Temp-to-Perm role with one of the world’s top ten largest global pharmaceutical companies in Boston, MA. Must have 10+ years experience in pharmaceutical industry and/or clinical research organization, including 7+ years clinical study/project management.
REQUIREMENTS for the AD, Clinical Operations Program Leader:
- Bachelors Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable
- 10+ years experience in pharmaceutical industry and/or clinical research organization, including 7+ years clinical study/project management.
- Experience must include clinical studies experience in global/international programs.
- Neuroscience experience highly preferred. 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 is also required.
- Demonstrated excellence in program management, including scenario assessment, risk assessment and contingency planning
- Demonstrated excellent matrix leadership and communication skills
- Excellent teamwork, organizational, interpersonal, conflict resolution and problem solving skills
- Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo
RESPONSIBILITIES of the AD Clinical Operations Program Leader:
- 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 line management, providing expert consult for issue resolution and assisting the relevant Director/Senior Director
- 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 Companhy 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 Associate Program Leader (APL) 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.
- Recognized as a clinical operations expert by other functions
- May include direct management, including coaching, training and performance management of more junior COPLs and APLs
- Direct management, including coaching, training and performance management of APL
- May assist the Director/Senior Director in his/her function, as required.