Director Medical Affairs (Franklin Lakes)

In this role, the Director will partner closely with the SM SA worldwide business team, regional leadership in the Medical Affairs Function, and the Director of Medical Affairs in Lab Specimen Management (LSM) to align and prioritize product development, product improvement, education, and clinical plans to support SMs value-based strategy. They 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.

The Director, Medical Affairs, will drive 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 product use.

The Director of Medical Affairs needs to have experience in understanding the preanalytical pathway of specimen acquisition and ability to identify technical and logistical barriers in it. This position requires operational experience with product development including clinical trial strategy, design and execution, demonstrated productivity in peer-reviewed publication and public speaking / presentation, as well as external KOL engagement. This position will 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.

Responsibilities :

• Works with the Business Unit Leadership to determine strategy for new product development, prioritization of projects. Manges resources to support new product development and sustaining life cycle management. Ensures understanding and support of BU WW strategy by all MA SA associates.
• Contributes to Business Unit or Medical Affairs KDGs (Key Driver Goals).
• Leads MA activities of new product development in SA to include concept ideation, interaction with cross functional development teams, and assessment of clinical evidence requirements to meet regulatory, safety and efficacy criteria and support commercial launch.
• Ensures proper study design, analysis, interpretation, and publication / presentation of study results with minimal supervision to maximize value to the business.
• Ensures appropriate input to the product teams for determining the potential clinical utility of any SA product under development by the BU.
• Reviews proposals for IIS (Investigator-Initiated Studies) and Collaborative Studies.
• Reviews advertising, educational, promotional materials.
• Determination of the safety and efficacy of both new and existing SA products for the BU.
• Reviews Clinical Study Reports and regulatory submissions to ensure adequacy of support for all claims pertaining to the safety, effectiveness, and clinical performance of all products. Provides clinical expertise in submissions and communication with FDA and other Regulatory authorities around the world as needed.
• Determining whether adverse health consequences exist for any SA 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.
• 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
• Keeps abreast of trends in health care diagnosis, deliver, and treatment of human disease, especially as these relate to the BUs product portfolio.

Qualifications :

• Advanced Nursing Degree Required (MSN, DNP, PhD etc.) including direct experience in clinical investigation
• Ability to work onsite 4 days / wk. in Franklin Lakes, NJ
• Minimum of 10 years experience in the Medical Device / In Vitro Diagnostics or related industry required
• Minimum of 6 years of experience successfully leading and developing teams
• Global exposure and understanding of medical / clinical practice as it relates to sample collection in various clinical settings and laboratory testing in diagnostics
• Experience in phlebotomy and specimen collection in a clinical setting required
• Experience in infection control highly desired
• Knowledge of clinical trial design, statistics, and data analysis. Should have a solid understanding of Good Clinical Practices (GCP) and FDA / ISO requirements for clinical investigation
• Record of successfully supporting product submission to US / EU regulatory authorities
• Knowledge of product development processes and a record of delivering new products to market
• 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 in order to effectively manage internal and external relationships and gain credibility in the role
• Leadership Skills - Team oriented with the confidence and integrity to lead and delegate effectively. Self-directed with strong initiative; leads by example.
• Able to demonstrate the key capabilities of Leadership Standard
• Results and Action Oriented - Driven to excel and capable of inspiring others to excellence as well
• Must be capable and comfortable of decision making based on experience and information at hand. 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 with minimal supervision
• 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 ~ 15% : 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 to communicate their intent
• Manage talent by mentoring direct reports who are nurses / phlebotomists / lab scientists on all technical and business aspects of SA products
• Budget and schedule accountability for group