Senior Director, R&D Innovation

Job Title

Senior Director, R&D Innovation

Requisition

JR000014607 Senior Director, R&D Innovation (Open)

Location

Bridgewater, NJ

Additional Locations

Dublin, IRL, Madison, WI, New York, NY

Job Description Summary

Job Description

The Senior Director R&D Innovation is responsible for identifying growth opportunities for our portfolio, enhancing R&D efforts within specific areas of focus, and accessing and recommending relevant technologies and capabilities to drive growth.

This role will be the single point of accountability for ensuring oversight and delivery of all R&D activities in supporting our portfolio innovation and bridging medical science to device engineering predominantly in the respiratory therapeutic area. This role is a member of the R&D Leadership Team, reporting directly to the Executive Vice President and Chief Scientific Officer, with a dotted line to the Executive Vice President, Operations and Quality.

In partnership with our business development group, Corporate Strategy and other internal stakeholders, the incumbent will apply scientific expertise and insights to help progress our TA portfolio to maximize our opportunities at Mallinckrodt and cultivate a strong scientific reputation and a network of clinical and device experts in the global R&D and innovation communities.

The incumbent will be expected to lead the R&D due diligence alongside all internal stakeholders towards identifying, assessing and eventually recommending assets that complement or supplement our current TAs and portfolio within them.

This position is key to developing and implementing our R&D business development capabilities supported by clear and effective processes and plans, including integration planning.

This individual is expected to work in a highly matrixed environment and enhance the cross-functional collaboration between the global device engineering organization with all functions of the R&D organization while demonstrating scientific leadership within the MNK organization and to our external stakeholders.

Essential Functions

• R&D single point of contact for business development opportunities
• Works closely with Global Device Engineering to implement and execute the business development and portfolio strategies in support of Mallinckrodt’s corporate and R&D goals
• Provides biomedical and scientific expertise and input into the product and portfolio strategic planning process
• Contributes to competitive portfolio analysis and creation of differentiated portfolio strategies
• Develops and implements critical development capabilities within the R&D organization with clear, effective processes and communication mechanisms including: defining, documenting, and providing training to identify, select, prioritize and assess key opportunities and execute due diligence processes
• Leads cross-functional R&D teams to enable clinical development of our biomedical technology
• Oversees R&D review and scientific/medical evaluation processes for new technology/product in-licensing proposals and manages potential partner communications and relationship.
  
  

Minimum Requirements

Education

• PhD in scientific areas of interest to MNK, MD or equivalent medical qualifications, Biomedical Engineering
  
  

Experience / Skills

• Minimum of 10-15 years drug/device development experience and expertise in a biopharmaceutical company with relevant experience in respiratory devices
• Must have in-depth knowledge of drug development and commercialization processes
• Demonstrated expertise and oversight of translational to late phase development or post-approval in the pharmaceutical/device industry; successfully executed a major late phase development or post-approval program
• Successfully interacted with regulatory agencies regarding indication and/or labeling issues
• Proven ability to establish relationships and credibility with KOLs and external stakeholders
• Significant cross-functional leadership/management experience and demonstrated collaboration across stakeholders
• Demonstrable knowledge of the commercial and environmental issues that drive asset/brand success
• Experience leading the strategy, planning, submission and execution of clinical trials preferred
• Track record of high performance in a relevant discipline within pharmaceutical development and/or commercialization, with a preference for exposure in across multiple therapeutic areas
• Experience leading development, medical or commercial teams
• Experience managing the drivers of commercial value in a clinical development and/or medical affairs role
• Experience with the process for developing a competitively superior product label
  
  

Desired Capabilities

• Global medical and/or device and/or regulatory experience in key markets
• Demonstrated excellence in international leadership behavior
• Knowledge of regulatory review and response processes
• Proven management and leadership skills
• Demonstrated initiative, creativity, strategic capabilities, and strong analytical and financial management skills
• Ability to work effectively in a cross-functional, matrix team environment
• Able to independently formulate development or lifecycle strategy
• Confident discussing scientific/mechanistic aspects of drug development, also comfortable in discussing commercial and regulatory issues
• Demonstrated ability to present data, plans and strategies clearly and accurately to relevant audiences in order to obtain decisions
• Strong understanding of the elements of drug/device development programs
  
  

Organizational Relationship/Scope

Reports to Executive Vice President, Chief Science Officer with a dotted line to the Exec Vice President, Operations and Quality.

Working Conditions

Office based in either Bridgewater, NJ or Dublin, IR; Anticipated Travel of 30%.