Director/Senior Director Clinical Development

Employer
Hobson Prior
Location
Maryland, USA, Gaithersburg
Salary
£143530.86 - £147631.74 per annum
Closing date
8 Oct 2020

View more

Discipline
Clinical Research, Clinical Development
Hours
Full Time
Contract Type
Permanent
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Hobson Prior are currently looking for a Director/Senior Director Clinical Development to join a late-stage biotech organisation, specialising in improving health all over the world through discovering, developing and commercializing pioneering vaccines to prevent serious diseases. This is a permanent position, located in Gaithersburg Maryland.

Job Responsibilities:

  • Accountable to lead the clinical development program.
  • Partaking in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals.
  • Directing human clinical trials, phases I-IV, for lead candidate in development, helping to ensure all clinical development milestones are met.
  • Coordinate and develop information for reports submitted to FDA, CDC, WHO, or other government, regulatory, or partner agencies.
  • Presentations to various external stakeholders - regulators, governing/harmonization bodies, principle investigators, scientific conference attendees, advisors and opinion leaders.
  • Knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review.
  • You will plan, review and edit Clinical Study Reports.
  • Providing input on the design of preclinical studies supporting clinical strategy.
  • Manage key external technology partnerships.
  • Other duties as assigned.

Key Skills:

  • Ability to work cross-functionally.
  • Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program.
  • Evidence of effective leadership skills.
  • Good verbal and written communication skills.

Requirements:

  • MD with vaccine product development and experience across stages of clinical development.
  • Minimum of 5 years' experience in pharmaceutical, biologics, or biotech R&D environment, or in a research environment involving the collection and analysis of human data in the area of infectious diseases.
  • Functional knowledge of concepts in vaccine immunology and vaccine development, preferably with experience in design and conduct of clinical trials.
  • Working knowledge of clinical development pathways for vaccines in the US and EMA.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Contact Us
  • Wellington Gate
  • 7-9 Church Rd
  • TN1 1HT
  • GB
  • 01892 612 612
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