Vice President & Clinical Executive Consultant

Date: Feb 24, 2024

Location: US

Company: Cytel Software Corporation

 

As a leader in next generation, data-driven pharmaceutical services, Cytel is shaping the future of clinical development. We deliver to the market high impact statistical consultancy on clinical development plans and individual trials, innovative analytical software for statistical analysis and simulation, and best-in-class data science analytics services. Our culture is inclusive, collaborative and results-driven with a shared commitment to quality. With operations across North America, Europe, India, and APAC, Cytel hires passionate and talented people who share its mission of ensuring the development of safe and effective health technologies.

 

We are hiring a Vice President & Clinical Executive Consultant (CEC) to join our Therapeutics Development Team, whose mission is to provide quantitative thought leadership around design, statistical methods, and decision-making during therapeutic product development. As a seasoned clinical development professional, you will leverage and broaden Cytel’s reputation for thought leadership and innovative services by leading engagements for pharmaceutical, biotech and device clients, and building and maintaining successful long-term relationships with clients in collaboration with Cytel’s business developers and other personnel related to the account.  This includes developing and demonstrating thought leadership in clinical trial design, statistical methodology, and strategic clinical development plans, ensuring that Cytel remains at the leading edge, and raising Cytel brand awareness and recognition throughout the industry. 

 

Specifically, we are looking for leaders with a strong foundation in clinical development, with deep and broad experience designing and executing clinical trials in all phases (I-IV) to support novel therapeutic product development (drugs or devices). Specific subject matter experience in statistics and/or unique knowledge in related quantitative areas (adaptive designs, clinical pharmacology, data science, model-informed drug development) would be advantageous for the successful candidate. Depending on skill set and qualifications, the EC’s role may also extend to provide strategic advice for clients to define optimal clinical, safety/pharmacovigilance, regulatory, and/or market access pathways and promote faster patient access to better health technologies.

 

Position may require 30-50% travel (post-Covid).

 

 Specific duties and responsibilities:

  • Responsible for business development, account management and/or project execution leading to a large client portfolio (in value and numbers). 
  • Identifies and pursues new business opportunities both within Strategic Design Consulting and across Cytel Business Units by identifying emerging customer needs and formulating appropriate solutions to meet revenue, profitability, and customer satisfaction objectives.
  • Act as an externally recognized thought leader and strategic advisor in the areas of optimal clinical development, regulatory, and/or market access pathways and quantitative strategies to promote faster patient access to better health technologies.  Routinely lead development of new methodologies and approaches and provide scientific support to Cytel’s multidisciplinary team to be disseminated through conferences, webinars and publications.
  • Assumes overall responsibility for assigned Strategic Design Consulting accounts and projects, acting as the client’s primary point of contact for Strategic Design Consulting engagements, developing mutually beneficial partnerships and taking ownership for the strategic needs of the client.
  • For assigned accounts or areas of expertise, act as a subject matter expert, working with other consultants and associates working on the account or in the area, with the goal of representing Cytel organization. 
  • The position requires regular travel, substantial direct contact with senior management and executives at prospects and existing clients, and the ability to build and leverage strong interpersonal business relationships both internally and externally to Cytel.

 
Qualifications and Experience:
 

  • MD, MD/PhD degree required, with subspecialty training and/or clinical practice experience desirable; at least 10+ years of experience in the consulting, clinical trials or health research environment.
  • Demonstrated understanding of the customer decision-making processes and constraints, with proven ability to develop and capture transformational opportunities.  Strong interpersonal skills with the ability to gain respect of and influence the management team, board members, and client personnel at all levels.
  • Thorough understanding of the biopharmaceutical R&D process in combination with solid business acumen and an appreciation of the broader business issues.
  • Strategic thinker with a global orientation, strong problem-solving and analytical skills, and the ability to execute in complex situations at the tactical level.  Proven management skills with the ability to build, mentor and motivate a strong team of consultants and analysts.
  • Experience interacting with regulatory agencies (FDA/EMA) and key opinion leaders to enhance development plans.
  • Collaborative, entrepreneurial and self-motivated, with an understanding of the dynamics of high-growth companies; the ability to work effectively in a challenging and sometimes rapidly changing environment.
  • Ability to design, initiate and conduct effective clinical studies applying novel principles as appropriate, and integrating these plans into a cohesive overall clinical development strategy.
  • Strong understanding of the complexities and current developments in a relevant disease/technical area, and ability to skillfully apply this knowledge to product development.
  • Firm understanding of clinical regulatory requirements, and knowledge of GCP and ICH guidelines.
  • High ethical standards for conducting clinical research.

 

Why Cytel?

  • You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
  • You will be part of an exciting new chapter in Cytel’s history with high growth and opportunities to progress to leadership positions within the company
  • You will work with and leverage the best and brightest minds in the industry.

 

 

 

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