Vice President, Medical
Company: Precision Medicine Group
Posted on: November 22, 2021
The VP, Medical provides supervisory oversight and direction to
assigned Medical Monitors (Medical Directors and Senior Medical
Director positions) in the North America region. The VP, Medical
will be responsible for assigning Medical Monitors to potential
projects involving the North America region at times broader during
the RFP process as well as awarded business as needed. The position
will be responsible for ensuring appropriate input and
representation throughout the proposal and bid defense process
including developing medical strategy in concert with Precision
strategy development group (Strategic Drug Development Solutions,
CMO, operational strategy and other members). Following the project
award, the VP, Medical ( will ensure the assigned Medical Monitor
fulfills their responsibilities, per SOP, with quality and to
client specifications and satisfaction and will serve as an
escalation pathway as needed to resolve issues and/or potential
conflicts. The VP, Medical will also serve as the project physician
and provide medical and/or scientific expertise to project teams,
based on assignment. The primary focus of the Medical Monitor role
in particular, is to ensure the accuracy and integrity of the data
resulting from the trial, with concentrated focus on patient safety
and the medical aspects regarding the protocol and data being
collected. The VP, Medical will participate in the Precision
Science and Medical Strategy team to provide strategic and
development consulting to oncology and rare clients to support
development pathways including participating in the medical input
during the integration of Medical, Clinical, Regulatory,
Translational and Marketing insights to inform a strategic
Essential functions of the job include but are not limited to:
Provides Supervisory and business management oversight to the
Medical Directors and Senior Medical Directors serving as Medical
Monitors on behalf of Precision for Medicine
Assesses medical monitoring needs of each program, the availability
of each Medical Monitor to meet the time requirements and the
medical/scientific needs of the program and the matching skills of
each Medical Monitor to supply the sponsor and team with medical
Assigns new opportunities requiring medical support to an
appropriate Medical Monitor
Ensures the Medical Monitor fulfills the execution of their work
per expectation, per SOP and with quality according to the protocol
and Precision systems
Develops strong and successful working relationships with key
members of Precision to ensure effective communication and medical
integration across projects, functions and initiatives.
Serves as Medical Monitor on assigned projects including:
Reviews and revises protocols, case report forms, training
materials, project specific tools, analysis plans, study designs,
clinical trial reports and new drug applications.
Reviews laboratory values, adverse events, coding dictionaries and
data tables, listings and figures as needed.
Assists in the development of the Medical Monitoring Plan (as
required) and materials for investigator meetings and staff
Assumes responsibility for medical and safety monitoring on
Interacts with team members and clients as necessary.
Participates and drives feasibility discussions relating to
specific project proposals.
Develops training modules and conducts training for project teams
and colleagues as necessary
Participates in training opportunities to advance knowledge of drug
development and Good Clinical Practice Guidelines.
Supports company's visibility and position with the CRO industry
through publications and presentations.
Develops and enhances client/investigator relationships whenever
Participates in process improvement activities.
Provides active participation for medical input for Precision's
Science and Medical Strategy Team to provide strategic and
development consulting to oncology and rare clients
Provides active medical support for business development activities
both in Europe and globally including input into proposals for
medical and strategic considerations as well as routine client
capabilities meetings as well as bid defense meetings
MD, MBBS or equivalent training with completion of training in a
At least 10 years combined experience in academic and/or industry
clinical research in drug development including experience as a
Medical Monitor on clinical oncology and/or rare trials
At least 5 years in drug development industry in oncology and/or
rare disease with previous exposure to clinical development,
regulatory and statistical activities such as (co) authoring and
reviewing of documents such as clinical trial protocols,
statistical analysis plans, IND AR, NDA AR, PSUR, DSUR, IB, ICF,
Orphan Drug Designations, regulatory briefing documents.
Working knowledge of the drug development process in the USA and EU
Ability to drive and availability for international travel
including overnight stays.
Approximately 30% travel requirement.
Clinical practice experience of a minimum of 3-5 years
Experience in direct interactions with US and/or EU Regulatory
Authorities highly preferred
For medical sub-speciality internal medicine or pediatrics
Completed fellowship in a Hematology-Oncology program preferred
Board certification preferred (including European equivalents)
Effective level of communication (both written and verbal) skills
and effective level of salesmanship and presentation skills.
Up-To-Date scientific and medical knowledge (know what you know and
what you do not know) to enhance the level of knowledge of the
physician and the organization to understand sponsor complex
science and goals in an expert manner.
Able to explore the literature and enhance knowledge level as
required to understand and discuss medically a clients development
program and make suggestions for more efficient development
Using the knowledge be able to discuss, and represent the sponsors
and clinical trial medical information to sites, other physicians,
regulatory agencies, congresses, professional meetings, business
meetings, and potentially investor meetings of Precision Medicine
Group and sponsors.
Ability to deliver on commitments, an understanding of the service
culture and demonstrates a high degree of professionalism, as
evidenced by punctuality, positive interactions with customers and
teammates, including good interpersonal skills.
People management competencies and team building skills.
Identifies training needs for direct reports and develop training
plans to address those needs.
Conducts formal presentations to a wide variety of audiences
including colleagues, investigative staff, and clients with a high
level of proficiency.
Fluency in English
Any data provided as a part of this application will be stored in
Precision Medicine Group is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, age,
religion, sex, sexual orientation, gender identity, national
origin, disability, veteran status or other characteristics
protected by law. - 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable
accommodation to complete any part of the application process, or
are limited in the ability or unable to access or use this online
application process and need an alternative method for applying,
you may contact Precision Medicine Group at
Keywords: Precision Medicine Group, San Diego , Vice President, Medical, Executive , Carlsbad, California
Didn't find what you're looking for? Search again!