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DIRECTOR OF MEDICAL AFFAIRS

UNITED STATES, UNITED STATES

Summary Description

 

Reporting directly to the business unit Vice President of Medical Affairsthe Director of Medical Affairs helps to provide strategic and medical/scientific leadership for the Business Unit.  The position shares responsibility for the safety and efficacy of all products within the business unit.  The Director provides strategic guidance to the product platforms within the business unit. This individual will manage Medical Affairs professionals who contribute to product ideation, concept development, product validation and qualification, legal and regulatory compliance, demonstration of product value, stakeholder education and risk/benefit assessments throughout the product life cycle.

 

The. Director of Medical Affairs will have familiarity with clinical trial strategy, design and execution.  The Director will have demonstrated productivity in peer-reviewed publication and public speaking/presentation, as well as external KOL engagement.  This leader is a proactive contributor to the business by working closely with R&D, Strategic Marketing, and Business Development to foster innovation within the Business Unit.

 

Primary Responsibilities

 

  • Contributes to development of business strategy.
  • Ensures understanding and support of BU WW strategy by all MA associates.
  • May lead, and always contributes to, Business Unit or BDX Medical Affairs KDGs (Key Driver Goals).
  • Provides MA support and input into innovation activities and new product development to include concept ideation, interaction with cross functional development teams, and assessment of clinical evidence requirements to meet regulatory, safety and efficacy criteria.
  • Manages other Medical Affairs team members including both US and OUS associates
  • Oversees consultation with associates from Global Clinical Affairs (GCA) to ensure appropriate clinical trial designs for both new and existing product development.  While GCA is responsible for study protocol development and study execution, BU MA ensures proper study design, analysis, interpretation, and publication / presentation of study results to maximize value to the business.
  • Reviews and approves proposals for IIS (Investigator-Initiated Studies).
  • Reviews and approves advertising, educational, promotional materials
  • Analyzes and Determines the safety and efficacy of both new and existing products for the BU.
  • Reviews regulatory submissions to ensure adequacy of support for all claims pertaining to the safety, effectiveness, and clinical performance of all products.
  • Determines if any adverse health consequences exist for any products that the business manufactures both during development and when marketed, through formal Risk Assessment procedures (FMEAs, SAs, HHEs, etc.) in cooperation with the Global Medical Safety team.
  • Provides guidance to MA staff in the WW Business to ensure success in clinical trials for product registration and determination of safety and efficacy for marketed products.
  • Ensures appropriate input to the product teams for determining the potential clinical utility of any product under development by the Unit.
  • May assist in the evaluation of potential new technologies for both core and OTHC (Outside the Home Court) products/services.
  • Provides clinical expertise in submissions and communication with FDA and other Regulatory authorities around the world.
  • Ensures MA support to the worldwide Sales and Marketing departments.
  • Builds effective connections, interactions and collaborations with clinical investigators and Key Opinion Leaders (KOLs) at a peer-to-peer level, worldwide.
  • Represents BU MA to professional societies and at medical and scientific meetings and seminars, often by invitation.
  • Keeps abreast of trends in health care delivery, diagnosis and treatment of human disease, especially as these relate to the BU’s product portfolio.
  • Other duties as assigned

 

Qualifications

 

  • Medical Degree (M.D., D.O. or equivalent) required
  • Minimum of 5 years of clinical experience in one of the surgical disciplines, including experience in clinical investigation.
  • MBA, MMM, MPH, MHA degree granted or in progress desirable.
  • Experience in pre-clinical research including experience in development and execution of pre-clinical models used for medical device development and evaluation is desirable.  Knowledge of GLP standards and regulations desirable.
  • Experience with medical device clinical evaluation
  • Demonstrated record of peer-reviewed publications and a regional or national reputation in the relevant medical field to the BU. 
  • Management/business experience required to include talent management
  • Global exposure and understanding of medical/clinical practice
  • Must have clinical knowledge obtained through medical education and medical practice.
  • Strong understanding of clinical trial design, statistics, and data analysis.
  • Influencing Skills - Establishes rapport, value and respect within a complex and highly technical environment internally, as well as with KOLs and other influential stakeholders, externally.  Able to influence directly and indirectly Initiate and effectively lead change efforts.
  • Interpersonal Skills - Effectively establishes and builds close working relationships across a highly matrixed organization and with alliance partners.  Strong personal credibility, written and oral communication skills.  Accomplished in group, business and social settings, respected by professional peers.  Comfortable and capable in a variety of cultures and skilled in working internationally.
  • Business Acumen – Demonstrates business acumen and maturity within a strong group in order to effectively manage internal and external relationships and gain credibility in the role.
  • Leadership Skills - Team oriented with the confidence, maturity and integrity to lead effectively. Self-directed with strong initiative; leads by example.  Able to demonstrate the key capabilities of the BD Leadership Standard.
  • Results and Action Oriented - Driven to excel and capable of inspiring others to excellence as well.  Envisions a winning future for the organization and help turn that vision into reality through strategic planning plus hands-on action.
  • Accepts accountability for results of the MA team and provides clear direction with input from others.
  • Problem Solving Skills – Brings a high level of intellect and curiosity to work. Able to apply mature business judgment in making decisions.  Creatively and effectively challenges the thinking of others.  Capable and effective in negotiations.  Able to see the cultural and personal implications of decisions and plan for them.
  • Willing to travel frequently, ~ 35%: U.S., Canada and international.
  • Must be able to speak and write English fluently; must be able to communicate clearly and accurately.
  • Must be able to understand legally and technically written standards, regulations, procedures, test methods so as to communicate their intent.
  • Generally, written rules, precedents and policies to determine or guide decisions are existing and accessible. Judgment calls will be made by this individual based on experience, education, and all available facts, since each project is unique. The individual must be able to initiate learning and decision-making without much initial information.
KP RECRUITING GROUP
 
KP Recruiting Group was started to create a world-wide network of multi-level, highly skilled talent; that are either experts or working to become one, in their respective fields. Our process involves focusing on the talent, skills, and experience of an individual as a key indicator of the present and future value that they will bring to any organization.

In establishing a network, we are able to forge genuine relationships with talent and gain valuable insight that allows us to understand what motivates them. This data allows us to give strategic advice to our partners as they go through the process of managing their human capital.

See our jobs and apply here: https://kprecruitinggroup.catsone.com/careers/7781-General

 
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