Director/Sr. Director, Clinical Operations Rare Disease in Waltham, MA at APEX Systems

Date Posted: 10/11/2019

Job Snapshot

Job Description

Job #:  1006296


Director / Senior Director, Clinical Operations, Rare Disease 1006296
Job Scope & Purpose:
Our client, a clinical-stage biopharmaceutical company, is developing novel RNA-modulating drug candidates to treat rare and ultra-rare diseases. We are seeking an experienced Director of Clinical Operations to lead and manage the execution of the clinical studies from protocol inception through study closure. Reporting to the Executive Director, Clinical Operations & Site Head, the Director of Clinical Operations, this key role will manage, plan and execute clinical studies for North America, including creating and managing study timelines, budgets and study management plans in a full out-sourced model. This is a great opportunity for visibility and professional growth; the Director of Clinical Operations will build the North America arm of our Clinical Operations and partner with the Executive Director to represent the Clinical Operations team cross-functionally and with key stakeholders.
Primary Job Responsibilities:
  • Ensures that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards
  • Oversees the day-to-day clinical operations in North America with a focus on vendor management (e.g., CRO, laboratories), monitoring clinical trial recruitment rate, and coordination of activities
  • Executes high quality, integrated cross-functional plans for the project/clinical trial
  • Responsible for the oversight of protocols development; protocol preparation, amendments, CRF, informed consent form, operations and other documentation required for the conduct of a clinical trial
  • Accountable for internal clinical trial files and documents
  • Participates and manages investigator meetings and follow up

Primary Job Requirements:
  • Minimum of 10 years’ experience in the pharmaceutical industry, with 5-7 years’ direct experience in planning and managing global clinical trials.
  • Proven successful track record of building and managing high performing teams.
  • Extensive experience managing clinical programs, CROs, budgets, and timelines.
  • Regulatory/EMA/FDA experience.
  • Good working knowledge of medical terminology, physiology and pharmacology and excellent knowledge of applicable U.S. and international regulations and guidelines.
  • Solid understanding of pharmaceutical clinical development processes and have experience with clinical monitoring.
  • Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues.
  • Strong leadership skills and self-awareness.
  • Experience presenting to a varied audience, including investors and upper management.
  • Complex problem-solving abilities with a focus on accomplishing assigned goals and objectives in a dynamic environment.
  • A team player who is able to effectively and flexibly lead cross-functional teams across diverse cultures, backgrounds, and styles.
  • Excellent communications and presentation skills, able to effectively inform key stakeholders and management of the status, issues, and solutions.
  • Strong organizational and planning skills are required, with a proven ability to manage budgets and timelines.
  • Detail-oriented, a self-starter and comfortable with broad responsibilities in a fast-paced, small company environment.
  • Excellent computer skills, proficiency with project management software tools.
  • Prepared to travel domestically and internationally (Israel and EU) as needed.

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.
jprice@stratacuity.com
 
Code: ClinOps
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 844-463-6178-6178.