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Clinical Operations Lead - Early Phase, Multiple Therapeutic Areas

Apex Systems Cambridge Full-Time
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Clinical Operations Lead, Early Phase Development, Multiple Therapeutic Areas, 954011

Job Scope & Purpose:

Are you a Clinical Operations professional of Director or AD leveling that enjoys applying strategy as well as hands-on execution?  Directly reporting in the CMO, our client is seeking a Clinical Operations Lead that enjoys early phase drug development and a diverse therapeutic portfolio.  This small, nimble environment allows the right candidate to feel their impact and work amongst an exceptional team of professionals that embrace a constantly evolving environment with a diverse portfolio of differentiated clinical development programs that have the potential to greatly improve upon current treatments and/or provide breakthrough solutions for complex diseases. 

The Clinical Operations Lead is responsible for the execution of the clinical development plan for the assigned development programs.  She/He also will work closely with the Clinical Leader on all aspects of program oversight and management. The position requires excellent leadership, deep experience in drug development and networking capabilities to maximize the use of external resources (CRO’s, KOL’s, consultants etc.) and to integrate with internal domain expertise.  

Primary Job Responsibilities:

  • Manage 2 to 3 clinical programs at late preclinical, phase 1 or phase 2 stages of development 
  • Operational clinical trial planning and execution according to study objectives, timelines, and budget
  • Management of study budgets, including Task Orders, Change Orders, expense accruals, invoice approval, and financial reconciliation
  • Work with line function leads to ensure all clinical and non-clinical deliverables are in place or scheduled to support clinical development plan; e.g. CMC, toxicology, DMPK, regulatory affairs, biostatistics, data management
  • Provide operational leadership into clinical development strategy discussions; assess the feasibility of operationalizing various strategic options

Primary Job Requirements:  

  • Master’s degree or equivalent education, preferably in a science or health-related discipline
  • At least 10  years hands-on experience in clinical trials management or clinical research in biotech/pharma industry
  • Demonstrated success in clinical development, particularly in Phase 1 and/or 2 clinical trials across multiple therapeutic areas  
  • Direct experience in the areas of oncology, immunology, gastroenterology, and dermatology are desired 
  • Strong project management skills and general understanding of project management tools, e.g. MS Project Gantt charts
  • Extensive experience in the selection and oversight of clinical CRO’s

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

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Code: ClinOps

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178

 

Recommended skills

Pre Clinical Development
Clinical Research
Clinical Trials
Drug Development
Biostatistics
Gastroenterology
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Job ID: 954011

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WHAT WE DO:

Apex Systems is a division of the 2nd largest IT staffing and services firm in North America. From consulting to staff augmentation, we connect top tech talent with great companies in all industries.

OUR CREDENTIALS: 

Apex earned Inavero’s Best of Staffing™ Client Diamond and Talent Awards for providing superior service to clients and job seekers, putting the company in the top 2 percent of all U.S. staffing agencies.

SUPPORTING OUR CONTRACT EMPLOYEES:

We take the time to understand a candidate’s talents and needs to ensure a good match with companies for contract, contract-to-hire, and direct hire positions. Each recruiter within Apex is focused on a specific skill area within infrastructure, applications, and project management. This focused discipline enables our local recruiters to work directly with our candidate’s and focus their talent on the right position at the right time.

WHO OUR CUSTOMERS ARE: 

We serve Fortune 500, mid-market, and emerging companies from a wide variety of industries, including communications, energy, financial services, government services, healthcare, technology, and utilities. 

WHERE WE ARE: 

Apex has branches in over 70 locations across the U.S. and Canada and more than 1,000 employees dedicated to supporting the needs of our clients and contract team members. Visit www.apexsystems.com to find a local branch or connect with an Account Manager or Recruiter.

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