Vice President, Drug Development

Job Title: Vice President, Drug Development
Contract Type: Permanent
Industry:
REF: 122778
Contact Name: Gerry Kennedy
Contact Email: gerry@rftgroup.ie
Job Published: about 7 years ago

Job Description

Vice President, Product Development Dublin

Our client is a fast growing specialty pharma company committed to improving patients? lives by acquiring, developing and commercializing innovative prescription pharmaceuticals for niche therapeutic markets. This growth-oriented company is focused on providing branded prescription pharmaceutical products to the US market. Their goal is to quickly build a profitable company through acquisitions, targeted promotion and judicious investment in infrastructure, and are now looking to include expertise in pharmaceutical drug development as a key platform to future success.

The Vice President, Product Development ( VP PD) will be responsible for developing and executing the company?s R&D strategy, building internal competencies and establishing external relationships that strengthen company capabilities. This hands-on position in a young company will be responsible for clinical development, regulatory planning and execution, evaluation of potential development projects for acquisition, generation of life cycle management projects, medical advocacy, communications and information, pharmacovigilance, compliance, drug safety as well as contributing to the development of commercialization strategies for products in select therapeutic areas.

The VP PD, reporting to the President and CEO, will be a key member of the executive committee and will partner with internal functional heads as well as key external parties. The VP PD will build and lead a small internal team, based in Dublin and USA and will work with a multidisciplinary network of experts to provide advice and leadership. This position will be based in Dublin and will require international travel, including to the US.

Key duties

  • Plan and execute all product development activities from conception through to marketing approval
  • Direct third party contractors, consultants and service providers to deliver projects according to plan ? formulation companies, manufacturers, clinical trial centres, therapeutic experts, regulatory advisors, building and developing relationships vital to the success of each project
  • Collaborate closely with commercial team to determine objectives and design of clinical trials to support potential product marketing claims and patents
  • Play key role in managing relationships with development and commercialization partners
  • Provide advice to the rest of the executive team on research and development options
  • Act as primary company contact with regulators across all jurisdictions, together with our regulatory advisors
  • Work closely with colleagues in Quality Assurance/control across all programs and activities
  • Develop and implement best practices and procedures
  • Evaluate new product development opportunities whether internally conceptualized or to be in-licensed/acquired including leading all R&D due diligence activities
  • Support communication of the Company?s vision for the future with internal and external stakeholders including key opinion leaders; utilize clinical data to position and influence adoption, positioning and reimbursement of our products

Qualifications

? Twelve to fifteen years of experience in managing product development activities at a senior management level in pharmaceuticals industry
? Compelling executive presence, a bright, articulate individual with the presence and credibility to work closely with executives, KOLs and key stakeholders. Must have exceptional judgment, strong business acumen, integrity, leadership and collaboration skills and be able to effectively influence others and build alliances
? Ability to effectively manage an R&D function including development programs to budget
? Excellent project management skills and ability to manage and direct multiple projects simultaneously
? Effective communicator and proven people management skills
? Significant understanding of FDA regulations and international regulatory requirements, clinical research methods and basic statistical procedures
? Proven ability to write original scientific documents such as clinical summaries, integrated NDA summaries, investigator brochures, pharmacoeconomic white papers for managed care reimbursement and internal reports
? Recognized as having expert clinical knowledge in multiple disciplines with Dermatology, Gastroenterology or Women?s Health experience being an advantage
? M.D. Degree with board certification or board eligibility in a related therapeutic area is ideal
? Must be innovative, strategic and able to execute detailed action plans
? Entrepreneurial, reliable, outcome-driven, collaborative, with the ability and desire to work as part of a small executive team
? Ability to work independently in a fast-paced environment



Cv to gerry@rftgroup.ie 01 2302400 www.rftgroup.ie