Senior Advisor Clinical Operations
Mapp Biopharmaceutical, Inc. "Mapp" is an innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases. The Senior Advisor Clinical Operations is responsible for providing deep technical expertise and assisting in the management of contract research organizations (CROs) and clinical development across programs at Mapp Biopharmaceutical.
- Masters degree or equivalent with 20-years minimum of relevant experience in Clinical Operations
- Experience in management, oversight, and execution of clinical trials conducted within and outside of the United States
- Experience in selection and management of CROs both within the United States and in Africa
- Previous experience conducting clinical trials and managing clinical sites and CROs in developing countries and in resource limited environments
- Experience making investigational drugs available to patients under FDA's expanded access regulations and other compassionate use provisions outside of the United States
- Experience interacting with ethical and regulatory authorities in central or western Africa or in equivalent countries with a similar setting
- Previous experience developing investigational products for the treatment or prevention of rare diseases
- Experience developing investigational products for the treatment or prevention of diseases in the context of ongoing epidemic(s)
- Experience with FDA Animal Rule requirements for licensing drugs
- Demonstrated ability to work remotely with domestic and international team and in the context of ongoing outbreaks or epidemics teams
- Willing and capable to assist with multiple projects and responsibilities
- Experience in management of clinical studies in the United States and Africa
- Ability to engage in domestic travel and international travel to the degree appropriate to support in-country operations and business of the team
- Understanding of FDA, GCP, ICH and/or other regulatory requirements that may impact global clinical studies and clinical trial management
- Detail oriented with proven organization, prioritization and collaboration skills
- Ability to work independently in a virtual team environment as well as within multi-disciplinary project teams
- Experience supporting government contracts
- Outstanding written/verbal communication and presentation skills
- Ability to manage multiple projects in a dynamic team environment which requires creativity, innovation and thinking outside the box
- Ability to influence colleagues and leaders in various departments
- Customer focused, passion to succeed and promote team work with high integrity
- Provides guidance in all aspects of conducting IND studies (Phase I-IV and expanded access), with emphasis on study design, planning and management
- Provides input and guidance on the selection, management and oversight of CRO and other vendors both within and outside the United States
- Assists the Mapp clinical operations team in providing technical leadership to its CROs through effective coaching and development
- Manages and assists in training team members in Africa for their roles to ensure compliance with study requirements, GCP and ICH Guidelines, and applicable local regulations
- Provides technical input and expertise to cross-functional project teams, prepares written and oral presentations, authors or reviews protocols, procedures, clinical study reports and collaborates/interacts with cross functional groups including Clinical Operations, Project Management, Regulatory and Quality
- Provides guidance and instruction to key clinical research personnel within Mapp and its subcontractors on current operating procedures, work instructions and project scope
- Assists with tracking and oversight of activities related to project progress, budget, timeline and resource allocation
- Participates in the development and implementation of process improvement initiatives
- Manages vendor, consultant and subcontractor activities both in the United States and Africa
- Provides technical input into the clinical operations group for deliverables from the development phase to regulatory filing for commercialization
- Provides mentorship, advice and guidance to Mapp clinical team members
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego, CA or may have the opportunity to work remotely. Domestic travel of approximately four times per year and international travel of less than two times per year will be required for this position. Mapp wants you to join their team and invites you to apply.
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Vets Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.