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23 days old

Associate Director, Clinical Operations Program Lead (COPL)

Kelly Services
Cambridge, MA 02238
Kelly is hiring a **Associate Director, Clinical Operations Program Lead (COPL)**


+ 12 month contract; if converted candidate will need to be local to Boston or relocate

+ remote

+ Pay: Negotiable

+ key meetings in Cambridge/Lexington - may be requests for travel to meetings (travel can be reimbursed)

+ Early phase experience strongly preferred but not required

+ Pharma industry experience a must


OBJECTIVES:


Provide operational expertise and strategic input to the development of Clinical Development Plans (CDP) supporting the overall clinical strategy for one or more clinical programs, which may include highly complex, high-risk, and/or high-priority 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 sponsors 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 at the Global Program Team (GPT) and partner with Global Clinical Lead to lead the Clinical Sub Team (CST) accountable for the development and execution of the CDP.

Take on functional leadership responsibilities, which may include line management, providing expert consult for issue resolution and assisting the relevant Director/Senior Director

Responsible for strategic cross-functional initiatives for process and/or business improvements


ACCOUNTABILITIES:


Accountable to the GPT for the translation of the CDP into an optimal operational strategy and plan. Ensures assessment of various scenarios operational 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 operational strategy and planning on assigned clinical programs in close collaboration with the Clinical Operations Managers (COMs), 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 COMs and 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 COMs, 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, guidance and support to the COM in the development of study strategy operational plans including enrolment models and risk management strategy.

Serve as the point of escalation for the COMs for issues that cant be resolved at the study level.

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 COMs, Strategic Partners/other CROs/other vendors to ensure inspection readiness.

Leads Clinical Operations aspects of inspection readiness activities and acts as subject matter expert during regulatory inspections

Lead cross-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 Takedas values

May become a line manager for Clinical Operations staff

Recognized as a clinical operations expert by other functions and stakeholders across R&D

Help with onboarding and mentoring of COMs and Senior Manager COPLs

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.

o Performs site feasibility/capability assessments for programs/studies requiring specialized experimental tests and/or technologies and work with internal experts and sites to ensure successful operational outcomes

o Work with Procurement, QA & Legal to qualify new clinical vendors and, when appropriate, manage vendors for duration of a study (for vendors contracted directly with Takeda)


EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:


Education:

Bachelors 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, communication, 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

Embody 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 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. 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.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-08-30 Expires: 2021-09-30

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Associate Director, Clinical Operations Program Lead (COPL)

Kelly Services
Cambridge, MA 02238

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