Sr. Director of Biocompatibility and Toxicology, Preclinical, Medical Device
Location:
Raynham , Massachusetts
Posted:
April 02, 2017
Reference:
6907170119/1-en-us

Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Sr. Director of Biocompatibility and Toxicology, Preclinical, Medical Device to be located in Raynham, MA, Somerville, NJ, Cincinnati, OH, Warsaw, IN, or West Chester, PA. 

 

Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales.  The business is expected to experience solid growth over the next 5 to 7 years.  Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products.


The Senior Director of Biocompatibility and Toxicology group in the Preclinical Center of Excellence (COE) will dead the toxicological and biocompatibility evaluation of products and technologies required for product approvals and patient safety across MD.  This individual will work closely with preclinical franchise leadership to understand project requirements, priorities and timelines to effectively assign resources for preclinical safety assessments.  The individual will interface with key internal stakeholders and regulatory agencies to deliver robust preclinical assessments that meet regulatory approval and ensure patient safety. The Senior Director of Biocompatibility and Toxicology will serve as a member of the Preclinical COE leadership team in developing an industry leading preclinical organization focused on innovation and patient safety.


The Sr. Director, Biocompatibility and Toxicology, Preclinical & Medical Device will:


Direct staff conducting toxicological and biocompatibility evaluation of products and technologies required for product approvals and patient safety across MD.

Partner with preclinical franchise leaders in the development of robust preclinical plans and evidence strategies to meet NPD goals and ensure patient safety.

Develop and implement biocompatibility and toxicology resourcing strategy that delivers executional excellence to projects.

Work with the preclinical COE’s Operations, Advanced modelling and Franchise leaders to execute product design evaluations and preclinical evidence strategies required for product approval and patient safety across MD.

Drive interactions with project teams early in the process to identify potential risks to projects and develop robust Biological Evaluation Matrix.

Interface closely with the Office of the Chief Medical officer to evaluate safety assessments of new and existing products for our patients.

Facilitate dialogue with key partners (Marketing, R&D, Clinical, Medical, Regulatory, HEMA, Quality) at the right time in the development process to ensure; Right Patient Needs are addressed, Right Evidence Data to support Claims and Rights Research is conducted. 

Oversee, manage and prioritize resources to conduct biocompatibility and toxicology assessments for projects across MD. Provide scientific input and rationale for highest potential projects to effectively direct and utilize resources. 

Partner with preclinical franchise leaders to develop preclinical project budgets to address patient safety.

Provide leadership and strong participation in the development of ISO standards and FDA guidance documents for MD testing.  

Interface with regulatory agencies and external thought leaders to anticipate and shape preclinical testing requirements required for ensuring approval and patient safety.

Identify appropriate animal and bench top models that may be used to drive product development and safety assessments.  Work within COE and across company sectors to develop biocompatibility and toxicology models.

Talent Development: Develop and strengthen the preclinical talent pipeline. Ensure right people in right roles across the Preclinical scientific ladder.


Qualifications
A minimum of a Doctorate degree (e.g. PhD, PharmD, MD or equivalent degree) in Toxicology, Biology, or a related scientific field is required
Board certification in ATS, DABT, DACVP, or related certification is preferred
A minimum of 15 years of experience in biocompatibility and/or toxicology group in a pharmaceutical and/or medical device industry is required
A minimum of 10 years managing a group that includes senior scientific staff (i.e. PhD or equivalent level staff) is required
Track record of directing high level staff to deliver on complex scientific assessments is required
Extensive knowledge of global toxicological and biocompatibility standards is required
Demonstrated leadership skills to serve as a change agent to identify needs and solutions, implement and support the transformation of a function is required
Ability to work collaboratively as a team across various functions in a challenging and changing environment is required
Experience with leading multiple projects, managing priorities, and resource management is required
Familiarity with Medical Device Product Development is preferred
This position will be located in Raynham, MA, Somerville, NJ, Cincinnati, OH, Warsaw, IN, or West Chester, PA and will require up to 35% domestic and international travel

Primary Location
United States-Massachusetts-Raynham
Other Locations
North America-United States-Pennsylvania-West Chester, North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-New Jersey-Somerville
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Clinical Research non-MD
Requisition ID
6907170119

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