Global Head of Clinical Development - Gastroenterology
- Experience Level
My client is looking for a true clinical expert in Gastroenterology and inflammatory bowel disease for an executive level clinical development position based at the company HQ.
We have an immediate need for a gastroenterologist to provide strategic and technical leadership for our inflammatory portfolio.
The role is responsible for the global design and conduct of the clinical development strategy Phase I-IV, overseeing trials in clinical development and pharmacovigilance.
The ideal candidate will establish and maintain close working relationships with clinical counterparts and stakeholders, providing the clinical-regulatory landscape for each of the clinical programs.
If you have a particular interest and expertise in Gastroenterology, in addition to significant pharmaceutical expertise in global clinical development, please read further.
- Provide leadership and guidance for all clinical development activities and operations to internal/external team members to ensure efficient execution
- Provide strategic direction on a suite of trial designs for each product addressing FDA, clinical practice and payer’s needs
- Ensure the timing and sequence of data informs optimal introduction and commercialization
- Lead internal/external study teams through synopsis/protocol development through final publication
- Build the international team and lead contract research organization (CRO) interactions
- Partner with the Access and Reimbursement team on optimal health economic and outcomes (HEOR) trials to secure conventional coverage and reimbursement
- Partner with Product and Patient Engagement teams to optimize patient input and testing for prototype products and lifecycle improvements
- Develop and maintain key opinion leader relationships and serve as the clinical lead for advisory meetings
- Establish and maintain relationships with alliance partners, internal/external stakeholders, investigators and opinion leaders to optimize performance on clinical trial activities
- Provides input to evaluate products for in licensing/out licensing
Qualifications and Skills
- Medical Doctor – Board certification or equivalent in Gastroenterology with sub-speciality in inflammatory bowel disease
- At least 10 years of overall relevant experience within pharmaceutical/biotech industry, healthcare practice and/or clinical research is required
- Experience interacting with the EMA, FDA and other regulatory authorities
- Experience across Phase I-III Clinical Development
- Extensive knowledge of basic and clinical science
- Demonstrated strategic and critical thinking, dynamic leadership and team-building skills; as well as the ability to perform effectively in an adaptive environment
- Opportunity to work within a world leading pharmaceutical company
- Highly competitive basic salary
- Enhanced bonus scheme
- Long term incentives
- Company car
- Health Insurances
- Home office flexibility
- Enhanced Pension Scheme
- Autonomy to make decisive change quickly
If you are interested, get in touch with me ASAP. Due to the popularity of this role, the deadline for applications will follow shortly.
Adam J. Bloomfield
Principal Consultant - Europe
Email: abloomfield (at) barringtonjames.com
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