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Head of Clinical Operations, 912455 in Wellesley, MA at Apex Life Sciences

Date Posted: 11/28/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Wellesley, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/28/2018
  • Job ID:
    912455

Job Description


Head of Clinical Operations, 912455

Job Scope & Purpose:

Our client is a growing biopharmaceutical company dedicated to developing and commercializing novel therapies for people living with dermatologic. The Head of Clinical Operations will be responsible for management and oversight of multiple clinical trials associated with our client’s lead development program, primarily a Phase 2b study, while fulfilling a key role in effective global development and management of relationships, and establishing strong partnerships with external partners including investigators, CROs, consortia, central labs, IRB and other external partners.

Primary Job Responsibilities:

  • Provide strategic input to clinical development programs including various clinical trial scenarios and associated risks and costs. Work closely with senior leadership to define operational strategies aligned with corporate goals.
  • Represent clinical operations function in corporate and clinical team settings.
  • Develop internal and external resource strategy to support corporate and program goals for development compounds.
  • Develop operational plans to ensure compliance with current regulatory guidance and GCPs.
  • Develop and manage vendor performance and quality metrics through contracts and periodic review meetings adjusting the scope of services as needed.
  • Develop and maintain productive partnerships with internal and external stakeholders (CROs, consortia, investigators) including communication plans and setting of program milestones.
  • Maintain a positive culture and strong working relationships across organizational functions.
  • Develop and update integrated program timelines and budgets through collaboration with internal and external stakeholders as required to support operational plan and lead clinical trial team meetings.
  • Provide oversight and guidance to clinical operations teams, documents and processes to ensure patient risk-benefit is optimized.
  • Report status of program milestones and escalate issues to corporate Head Operations on the agreed schedule. Identify program risks and develop and manage mitigation plans.
  • Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, monitoring plans, study reports, and annual reports.
  • Contribute to clinical operations functional excellence through process development and working groups.

Primary Job Requirements:

  • Bachelor’s degree in life sciences or business administration required. Advanced degree/ clinical research certification desirable.
  • Demonstrated knowledge of the drug development process with clinical operations management experience and skills. Dermatology experience preferred.
  • At least 5 years of experience in clinical operations leadership across multiple Phase 1 – 4 global studies in a CRO or bio-pharma setting
  • At least 5 years of experience managing clinical staff including study managers, CRAs, monitors, and coordinators
  • At least 5 years of experience in managing CROs and other vendors
  • Demonstrated knowledge of FDA/EMA/GCP/ICH guidelines
  • Experience with clinical quality assurance, data management and statistical analysis in Phase 1-4 clinical trials
  • Experience with managing the US expanded access programs and ex-US managed access programs is desirable
  • Willingness to work in a dynamic and changing corporate environment
  • Accommodates a flexible work schedule according to clinical trial(s) priorities, as needed
  • Must be willing to travel, both domestically and possibly internationally

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 at info@stratacuity.com or 877-787-2821.

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.




912455