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Vice President, Product Development

Chicago, IL

Posted: 09/23/2020 Employment Type: Direct Hire Job Category: Clinical: Scientific Job Number: 2639

Job Description

The Vice President, Product Development is a critical role responsible for the strategy, direction and execution of the Company’ s research and development plans based on the Company’ s proprietary formulation platforms. This position will lead the planning and execution of programs from inception through preclinical manufacture/ screening, technology transfer to selected CDMOs, early cGMP manufacture collaborating closely with Quality and CMC counterparts as well as any necessary analytical method development, specification development, and assessment of stability data/programs.

Essential Job Functions:
  • Support technology platform and product development through acquisition of supportive pre-clinical and clinical data, intellectual property, regulatory interactions, etc.
  • Promote and lead the development and evolution of existing and new pharmaceutical products from discovery through clinical testing, provide support for commercial products as necessary
  • Develop and monitor research plans and budgets for internal and external research and development projects and ensure projects are completed on time and within cost; interface with the finance department to maintain up-to-date budget projections
  • Ensure adequate human, facility and equipment resources to support Product Development plans, including external vendors (CRO, CDMO)
  • Support aseptic manufacturing and testing of clinical trial materials, and technology transfer to internal and external business partners.
  • Participate in regulatory interactions as necessary to support the research and development programs; author and review relevant sections of regulatory documents (IND, CTx, NDA, MAA, etc).
  • Facilitate senior leadership team and drug project governance for research and development; collect and organize scientific data and intellectual property obtained from development projects to support Go/No decisions advancing key products and technologies
  • Use creativity in developing resource efficient and cost-effective plans for assessing new product concepts
  • Interface cross-functionally to review new product concepts; support technical assessment, development plans, business rationale, and due-diligence
  • Collaborate with business development team to drive new technical alliances, joint ventures and product licensing opportunities through external R&D programs; support alliances with external pharmaceutical partners coordinating technical assistance, proposals/contracts, and project management
  • Provide leadership, direction and coordination across functional areas to drive integrated delivery of product development programs and associated projects
  • Execute and deploy research development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones within budgets
  • Manage the professional development of direct reports through deployment of a proactive talent management strategy, active coaching and mentoring
  • Oversight of compliant lab operations 
  • Ensure scope of work, planning, expectations and project timelines are clearly communicated and aligned with product development team members and all key stakeholders
  • Ensure all research and development activities are carried out in compliance with all appropriate SOPs, guidelines and standards in accordance with GLP regulations

Requirements / Qualifications:
  • PhD in Pharmaceutical Sciences, Chemistry or related field
  • 15+ years of increasing responsibility working within formulation development, analytical method development and CMC, particularly working with novel formulation and/or drug delivery platforms.
  • Combination product experience is a plus.
  • 8+ years management experience, including experience building highly functioning teams
  • Demonstrated creativity in developing new formulation platforms and products
  • Knowledge of GLP and GMP regulations as well as ICH and FDA guidelines
  • Proven experience managing CDMOs at all stages of development, particularly as it pertains to aseptic manufacturing
  • Familiarity of analytical method development activities, HPLC/UPLC experience, experience using compendial methods for the characterization of parenteral products
  • Prior experience with the development of early phase clinical CTM specifications
  • Experience writing NDA, IND and other regulatory submissions
  • Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic and evolving environment
  • Competencies:  Strong Business Acumen, Executive Presence, Strategic Leadership, Innovative, Skilled Communicator, Team Developer, Excellent Judgement, Analytical, Complex Problem Solving, Highly Organized, Detail-Oriented
  • Some domestic and international travel required
  • Position may require periodic evening and weekend work, as necessary to fulfill obligations

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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