Head of Development - Biologics - UK - Home Based
- Experience Level
Position: Head of Clinical Development
Company: Biologics Organisation
Reporting too: CMO
Remuneration: Very competitive salary and package
Location: Home Based
This is a key position in Clinical Development responsible for developing and driving clinical strategies for one or more products in the pipeline and ensuring that they are efficiently shepherded through the clinical trials and regulatory process. This person will be accountable for execution of all global clinical development activities for the assigned projects for worldwide registrations.
The person will lead a team of highly qualified professionals including project physicians, clinical study managers, biostatisticians, clinical pharmacologists and pharmacovigilance physicians in a matrix environment and provide medical and clinical leadership to development programs targeting various therapeutic areas.
- Provide strategic direction in managing and driving assigned clinical development programs through all phases of clinical trials in accordance with global standards
- Responsible for the strategy- including understanding the commercial objectives, regulatory objectives and baking them into the clinical development strategy for one or more programs. Responsible for the design and execution of clinical studies, review of clinical data and preparation of study reports and regulatory documents
- Interact with global regulatory agencies and accountable for simplifying and narrating the story fluently and convincingly. Negotiating program related topics in agency meetings.
- Help devise plans to continue adding value based improvements to the program and provide critical inputs to expand access of existing compounds
- Provide strategic and scientific inputs in evaluation of potential licensing opportunities and new technologies
- Work closely with BD/ marketing functions & guide project physicians to provide inputs on product positioning and assessment of medical needs
- Provide leadership in facilitating interactions with key national & international opinion leaders
- Mentor, guide and support clinical development sub-team members to elevate their quality to global drug development standards
Professional Experience and Qualifications:
- MD or Ph.D. with 15 plus years of global clinical development experience.
- Must have experience in Biologics. Experience in Diabetes, Immunology or Oncology is a plus.
- Demonstrated experience in devising clinical development strategies and execution in all phases of trials in a global setting
- Experience in leading a clinical development team in a matrix environment.
- Experience in managing collaborations, consultants and sponsor oversight of outsourced activities.
- Experience/Understanding of global clinic-regulatory requirements for Biosimilars is a plus.
For more information, please reach out to me directly!
+44 1293 77 66 44