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Sr Director Medical Affairs Full-time

at BD in Rhode Island (Published at 21-09-2019)

Job Description Summary

Job Description

Reporting directly to the business unit Vice President of Medical Affairs, the Sr Director of Medical Affairs has the responsibility to support the VP, Medical Affairs in providing medical, scientific and technical customer-focused leadership and strategic perspectives across the Surgery business unit, as well as acting as the lead medical expert where assigned. The position will help drive the safety and efficacy of all products within the business unit. The role helps ensure the strategic and operational excellence of the Medical Affairs function and its members for this business unit. This individual will be responsible, along with Vice President of Medical Affairs, for management of the team of 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.

In this role, the Sr. Director will partner closely with worldwide business teams as well as regional leadership and the central Medical Affairs Function to align prioritized product, educational and clinical plans to support BD?s value-based strategy.S/he will oversee the development, update and implementation of the MA Policies and Standard Operating Procedures to optimize MA functioning in terms of leadership, compliance and productivity.

Where assigned, the Sr. Director, Medical Affairs, will be responsible for establishing and updating the Integrated Medical Plan (IMP) and driving the clinical development and evidence generation plans as well as publication and scientific exchange plans to contribute to product development, meet regulatory requirements and support appropriate use.

The Sr. Director of Medical Affairs needs to have strong strategic and operational experience with clinical trial strategy, design and execution, demonstrated productivity in peer-reviewed publication and public speaking/presentation, as well as external KOL engagement. It is also very important for this leader to be 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 overall worldwide business strategy.
  • Works with the Vice President of Medical Affairs and the Business Unit Leadership to determine strategy for new product development, prioritization of projects and resource management for the business.
  • 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).
  • Leads MA activities of innovation 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.
  • Oversees consultation with associates from Global Clinical Development (GCD) to ensure appropriate clinical trial designs for both new and existing product development. While GCD 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
  • Determination of the safety and efficacy of both new and existing products for the BU.
  • Reviews all regulatory submissions to ensure adequacy of support for all claims pertaining to the safety, effectiveness, and clinical performance of all products.
  • Determining whether there exist any adverse health consequences 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.
  • Works in close association with the VP of R&D and any research or other business groups involved with the exploration of potential new technologies for both core and OTHC (Outside the Home Court) products/services.
  • Provides senior-level 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.

Qualifications

  • Medical Degree (M.D., D.O. or equivalent) and with at least 5 years of clinical experience in one of the surgical disciplines, including experience in clinical investigation.
  • Minimum of 5 years? experience in the Medical device/Bio-pharmaceutical industry strongly preferred. Experience in both Medical Device and Bio-pharma a significant plus.
  • MBA, MMM, MPH, MHA degree granted or in progress desirable
  • Global exposure and understanding of medical/clinical practice.
  • Must have clinical knowledge obtained through medical education and medical practice. Needs knowledge of clinical trial design, statistics, and data analysis. Should have an understanding of Good Clinical Practices (GCP) and FDA requirements for clinical investigation.
  • 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
  • Demonstrated record of peer-reviewed publications and a regional or national reputation in the relevant medical field to the BU. Ability to qualify for at least Assistant professorship at an academic medical school and attending privileges at an academic teaching hospital desired.
  • Influencing Skills - Able to establish 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. Able to initiate and effectively lead change efforts.
  • Interpersonal Skills - Able to establish and build 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 ? Able to demonstrate 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. Able to envision 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.
  • Management/business experience required to include talent management and budget accountability.

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Primary Work Location USA RI - Warwick

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