Medical and Safety Director

Seuss+

As the Medical and Safety Director will be responsible for the company's medical and safety monitoring for all of our active programs.

  • Biotechnology
  • Clinical & Medical
  • Director
Medical and Safety Director
 
This is an amazing career development opportunity to make a name for yourself and develop our client’s global business. You will have a voice to contribute to the team and their continued growth. You will play a strategic medical and safety role in this position and you will have the proven creative skills to collaboratively contribute with our clients and their customers global success. Oh, and do not be shy of being hands-on in this growing team.   
 
Our client is a clinical stage biotech startup founded in 2018 with the purpose of improving the lives of patients and their families by developing treatments for neurodegenerative and neurodevelopmental disorders. 
The company is led a world-renowned scientist in Huntington Disease research. He has led the development of ~35 new products towards approval in several major markets, predominantly in CNS.
The company has recently raised a significant amount in a Series A financing round to launch the planned HD and ALS late-stage clinical trials.
 
The Role
As the Medical and Safety Director will be responsible for the company’s medical and safety monitoring for all of our active programs (including two upcoming potentially registrational trials in HD and ALS), as well as managing and contributing to general clinical and medical activities of the company. Working closely with other team members globally, the Medical & Safely Director will also play a significant role in working with external KOLs, CROs and other stakeholders.
The position will be based either in the US East Coast or the Netherlands and may require ~30% travel.
The company offers a versatile, energetic, and hands-on work atmosphere with a strong and dynamic team which revels in the excitement of working in biotech.  If you are self-driven with strong problem solving, scientific and analytical skills we would be delighted to hear from you.
 
Roles and Responsibilities:
  • Lead the Company’s medical and safety activities, working closely with management and external advisors and consultants. These activities may include but are not limited to:
    • Medical and safety oversight of active trials
    • Monitor study progress, ensure proper study conduct and adherence to the protocol, participate in data review, evaluation, and analyses in collaboration with clinical operations and other internal and external functions
    • Provide medical input and contribute to the clinical development sections of regulatory documents such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy)
    • Ensure that Serious Adverse Events are properly reported on a global basis.
    • Lead major reports and clinical/medical/safety documents preparations (e.g. IB, DSUR, clinical reports)
    • Facilitate the company’s response to clinical/medical/safety questions from Regulatory Authorities and IRBs
  • Establish and lead the Company’s safety monitoring and pharmacovigilance practices.
  • These activities may include but are not limited to:
    • Develop the integrated safety database
    • Oversight of CRO pharmacovigilance activities including medical monitoring and safety reports, SAE coding and narratives etc.
    • Develop and maintain Reference Safety Information (RSI)
  • Play a role in the company’s clinical, medical, safety and regulatory strategy:
    • Provide medical input for clinical trials in various stages, including registrational, managing the process from protocol development through study execution to completion of study reports and integrated regulatory documentations
    • Contribute to regulatory strategy and future submission plans and documents
    • Contribute to strategic clinical development plans
    • Participate in clinical meetings and presentations
Required Education, Skills & Experience:
  • MD degree required
  • Minimum 4 years drug safety, clinical research, or healthcare related experience including clinical trials adverse event reporting
  • Minimum of 4 years pharmaceutical industry experience
  • Detailed knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments
  • Experience with clinical study design, regulatory submissions, and interactions
  • Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high-performance standards and attention to detail
  • History of successful collaboration and execution in a global team environment
  • Record of analyzing and interpreting data and developing written reports and presentations of those data
  • Strong and analytical thinking skills
  • Strong interpersonal skills, self-driven, hands-on mentality, with strong problem solving, scientific, critical, strategic, and analytical skills
  • Excellent verbal and written communication skills, including strong formal presentation skills
Preferred Education, Skills & Experience
  • Neurology experience
  • Prior experience working with registrational trials
 
Please contact both Ian and Syeda. Either Ian and Syeda will respond to your message.
Ian wood, i.wood@consultsuess.com
Syeda Islam, s.islam@consultseuss.com