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Vice President, Medical

Company: Precision Medicine Group
Location: Carlsbad
Posted on: November 22, 2021

Job Description:

Position Summary

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 development pathway

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 expertise
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 training sessions.
Assumes responsibility for medical and safety monitoring on assigned projects.
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 possible.
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

Qualifications

Minimum Required:
MD, MBBS or equivalent training with completion of training in a medical sub-specialty

Other Required
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 is required.
Ability to drive and availability for international travel including overnight stays.
Approximately 30% travel requirement.

Preferred
Clinical practice experience of a minimum of 3-5 years preferred
Experience in direct interactions with US and/or EU Regulatory Authorities highly preferred
For medical sub-speciality internal medicine or pediatrics preferred
Completed fellowship in a Hematology-Oncology program preferred
Board certification preferred (including European equivalents)

Competencies
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 strategies.
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

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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 QuestionForHR@precisionmedicinegrp.com .

Keywords: Precision Medicine Group, San Diego , Vice President, Medical, Executive , Carlsbad, California

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