Senior Director, Clinical Development - Hemophilia

Seuss+

Our Amsterdam based client is seeking a Senior Director, Clinical Development experienced in Hemophilia

  • Biotechnology
  • Clinical Development
  • Hemophilia
Our client is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function is directly or indirectly responsible for the lives of patients. This responsibility is part of our day-to-day working lives by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
  
Position
The Senior Director Clinical Development – Hemophilia will serve a key role of providing expert medical input to the company’s ongoing portfolio of gene therapy-based rare diseases programs with a focus over assigned gene therapy programs in hemophilia and bleeding disorders. This will include the design, implementation, execution, medical monitoring and reporting of requisite clinical studies at all phases of pipeline development.
  
The Senior Director Clinical Development – Hemophilia, will report to the Vice President, Clinical Development (VP-CD), and collaborate closely with the VP-CD and VP-Clinical Operation, to address current and future pipeline needs for our client moving forward.
  
A summary of the responsibilities includes the following:
  
  • Serve as the Medical expert in relation to assigned studies/projects in the matrixed Core Project Teams (with Project Management, Clinical Operations, Regulatory Affairs, Database Management & Programming, Biostatistics, Commercial, and Pre-Clinical)
  • Support design, development and implementation of IND for Hemophilia programs
  • Proactively identify program risks, and create and implement mitigation strategies
  • Serve as a liaison with investigators and potential clinical sites
  • Handle day-to-day clinical, medical, scientific questions from various internal and external sources
  • Collaborate cross-functionally in the preparation of the IND, CDP, BLA, clinical protocols, investigator brochures and target product profiles
  • Participate in the ongoing interpretation and analysis of pre-clinical and clinical trial results including pharmacokinetics, pharmacodynamics, laboratory, imaging, and antibody data
  • Review and approve clinical trial coding, safety monitoring in collaboration with pharmacovigilance expert and clinical trial medical monitors
  • Participate as medical expert on the disease state and assigned clinical trials in various scientific advice meetings with the EMA and FDA, or other Regulatory bodies to support the VP Clinical Development, CMO and Regulatory
  • Continual review and analysis of the pertinent medical (disease-specific) literature
  • Preparation and/or delivery of abstracts, posters, and slide presentation at external Conference Symposia, and manuscripts for peer-reviewed journals
  • Collaborative with the company’s Discovery Research department to bring a medical disease perspective and analysis of unmet need to new gene therapy product candidates (either in-licensed or internally developed).
  • Focused medical review of emerging pre-clinical product candidates at Stage Gate #1, with collaboration with the VP Clinical Development in design of an early high-level clinical development plan (CDP)
  • Collaborate with the commercial part of the organization as needed for perspective on disease incidence and prevalence of orphan indications and to ensure development programs are aligned with commercial expectations
  • With Business Development, participate as a medical expert in Company due-diligence exercises on potential in-licensing of pipeline gene therapy programs
The successful candidate we hire will be a sophisticated clinician who has the right degree of drive and independence with a very strong track record in drug development. S/he will have the following mix of personal and professional characteristics:
  
  • Medical education (MD) and clinical development industry experience required. Board certification/eligibility in Hematology preferred
  • Strong scientific, clinical development and regulatory expertise; knowledge and experience in clinical trials for specialty biologics for rare disorders and gene therapy required
  • Experience collaborating cross-functionally on IND and BLA preparations and other routine regulatory engagements supporting clinical development through product approval
  • Excellent working knowledge of applicable global, regional, local clinical research regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs.
  • Proven ability to meet strict deadlines; manage competing priorities and changing demands
  • Sound organization and time management skills.
  • Good attention to detail and accuracy whilst maintaining high quality GCP standards.
  • Ability to follow instructions/guidelines, work independently and proactively on own initiative, and keep management/stakeholders informed.
  • Ability to be flexible and receptive to changing process demands
  • Willingness and aptitude to learn new skills, and support activities across service lines.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients – many with diverse cultural backgrounds
  • Skill required to create buy-in from functional groups and departments
  • Outstanding communication skills; comfortable representing the company and vision to internal and investor communities.
  • Confident, independent and decisive; a self-starter, proactive and results-oriented with high performance standards. Passionate, persistent and tenacious. Strong ability to prioritize and operate with a sense of urgency.
  • “Hands-on”, “roll-up-the-sleeves” contributor who understands the need for involvement at all levels of activity within a small company environment. Extremely bright with a highly strategic nature but also balanced with a biotech mindset and an attitude that gets things done.
  • Understanding of and willingness to meet applicable regulatory, quality and compliance standards.  Trustworthy with highest integrity, committed to ethics and scientific standards.
  • Willingness to travel (domestic/international, approximately 20%-30% time) to meet investigators, attend conferences, and participate in advisory boards.