What are the responsibilities and job description for the Senior Advisor – Clinical Operations position at MarginPoint?

Senior Advisor - Clinical Operations

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FULLY REMOTE

Part Time - 75% Effort

Job #25-01A

Mapp Biopharmaceutical, Inc. ("Mapp") is a San Diego based, 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, and in support of biodefense programs.

The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory, Project Management, and Clinical activities consistent with Mapp's product development objectives.

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.

Basic Qualifications

BS Degree in related Scientific field; Masters degree preferred
10 years relevant experience in Clinical Operations including 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 developing, executing and overseeing pre-marketing pharmacovigilance programs
Experience with FDA Animal Rule requirements for licensing drugs
Demonstrated ability to work remotely with domestic and international teams in the context of ongoing outbreaks or epidemics
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 and international travel to support in-country operations and business of the team (approximately six to eight times per year)
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
Experience working with the US government Biomedical Advanced Research and Development Authority (BARDA)
Outstanding written / verbal communication and presentation skills

Preferred Qualifications

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 teamwork with high integrity

Responsibilities

Provides guidance in all aspects of conducting IND studies (Phase I-IV and expanded access), with emphasis on study design, planning, safety program oversight and study 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, work instructions, 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 Outside the US (e.g. Africa and Asia)

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. Mapp's anticipated pay scale for this position is $130,000 to $250,000 (will be pro-rated based on effort), plus any applicable bonuses. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the candidate's level of education, and type and length of experience within the job and / or within the industry. Medical, dental, and vision insurance benefits are available to eligible employees and their families. Mapp also provides basic life insurance, short and long term disability, and a 401K plan that includes Company contributions to eligible employees. Full time employees will be provided 7 days of sick time, 14 paid holidays, and will also accrue 18 days of vacation throughout the calendar year.

If your job responsibilities allow, you may choose to work remotely. Willingness to travel (Domestic and / or International Travel = Approximately 6 to 8 Times Per Year) will be required for this position.

Mapp wants you to join their team and invites you to apply by submitting your information through the Mapp Biopharmaceutical, Inc. Job Openings website page. This job will remain open for twenty (20) days after being posted on Mapp's Job Openings website page.

No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.

Mapp is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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Salary : $130,000 - $250,000

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