VP/Sr. Dir Clinical Operations - Orphan Disease in Boston, MA at APEX Systems

Date Posted: 12/4/2019

Job Snapshot

Job Description

Job #:  969695
Vice President, Senior Director Clinical Operations, Orphan Disease, 969695
Job Scope & Purpose:
Our established client is seeking a strong leader as VP Clinical Operations to lead their innovative approach across all phases of development to improve the lives of patients with neurological disorders.  The VP of Clinical Operations will lead a strong team of clinical professionals while building a clinical presence in Boston.  This individual will develop strategies and processes to optimize quality, cost and timelines across the Company’s clinical programs in all phases of development (Phases 1-4).  The individual will be a key member of a highly collaborative Clinical Development team in a hands-on capacity that will have direct reports.
Primary Job Responsibilities:
  • Develop and propose standards and processes to optimize all aspects of clinical trial operations in compliance with global regulatory standards and in collaboration with other key functional areas, external vendors and advisors, including study feasibility; CRO selection and contracting; site initiation and oversight; patient recruitment strategies and plans; trial project plans integrating CRO team and practices with internal team; tracking and monitoring of trial progress against plans
  • Assign Clinical Operations staff to programs and trials to optimize both trial conduct and professional development of individual team members
  • Closely collaborate with Chief Medical Officer, Therapeutic Area Heads, Clinical Science, Biometrics, Regulatory, Clinical Supply, and Development Program Management to ensure highly integrated cross-functional project plans for programs and trials
  • Provide Clinical Operations input to a wide variety of scientific, clinical development and regulatory document types including Clinical Development Plans, protocols, synopses, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses
  • Represent the Company and Clinical Operations function in interactions, both in writing and in person, with CROs, FDA, EMA and other Health Authorities, Investigator Meetings, Advisory Boards, and other interactions with Key Opinion Leaders
  • Maintain current knowledge of relevant issues related to trial design, drug development, Health Authority regulations, and competitive trends to inform input and recommendations
  • Develop and maintain relevant Standard Operating Procedures and other policies, procedures, and systems relevant to the department; collaborate with Quality to plan and execute activities related to GCP
  • Develops and proposes short and long term goals for the department in accordance with overall Company and Development strategies
  • Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies
  • Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices

Primary Job Requirements:
  • Postgraduate degree with a minimum of 15 years management experience in a pharma or biotech environment, ideally some experience in neuroscience
  • Deep and broad experience in all aspects of Phase 1 to 3 global clinical trial design and execution
  • Experience in CRO selection, contracting and relationship management
  • Excellent leadership and interpersonal skills, ability to build credibility and trust inside and outside the Company
  • Proven ability to build and develop high performing teams; excellent delegation and conflict resolution skills
  • Be science and data-driven while at the same time, creative and flexible in strategic thinking and problem solving
  • Ability to travel up to 15%, both domestically and 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.
jprice@stratacuity.com
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.