- Provide operational expertise and strategic input to the development of Early Clinical Research Plans (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.
location: Cambridge, Massachusetts
job type: Contract
salary: $45.00 - 51.36 per hour
work hours: 9 to 5
- 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 Company 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.
- Collaborate with Strategic Partners/other CROs/other vendors to ensure inspection readiness.
- May contribute to functional 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´s values.
- For certain types of studies and programs, COPL may have the following responsibilities:
- Is a key point of contact between the strategic partners/preferred supplies and the GPT/CST.
- 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
- Work with Procurement & Legal to qualify new clinical vendors and, when appropriate, manage vendors for duration of a study (for vendors contracted directly with Company)
- Bachelors Degree or international equivalent required, Life Sciences preferred
- Experience in project/program management, including scenario assessment, risk assessment and contingency planning
- Demonstrated strong 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 support change
- Is comfortable with ambiguity
- Support a culture of continual improvement and innovation; promote knowledge sharing
- Fluent business English (oral and written)
- 6+ years experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study/project management. Experience must include early phase clinical studies/Phase 2 studies or later phase global/international studies or programs. Experience in more than one therapeutic area is advantageous.
- Knowledge 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 a plus.
- Ability to sit and stand for long periods of time.
- Carrying, handling and reaching for objects.
- Manual dexterity to operate office equipment i.e. computers, phones, etc.
- Requires approximately 5-20 % travel, including overnight and international travel to other Company sites, strategic partners, and therapeutic area required travel.
skills: Project Management, Phase II, Phase iii, Phase iv, Clinical Study Design
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.