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Sr. Medical Director, Clinical Development

Location Boston, Massachusetts, USA Jobb-id R-200236 Datum inlagd 05/21/2024

Position Summary

The Senior Medical Director, Clinical Development will provide medical leadership and input to Program Teams during the early stage of drug development (i.e., transitioning molecule through IND/CTA and First-in-Human study stage to Proof-of-Concept and End-of-Phase-2 stage).  The incumbent will serve as medical expert for the study team and medical monitor for phase 1b-2a/b clinical trials.

The Senior Medical Director, Clinical Development is typically responsible for multiple clinical development programs in a therapeutic area spanning IND to POC/Phase 2 under the supervision of either an Executive Director or a VP Clinical Development TA Head.  In addition, she/he may also have responsibility for discrete, specific business development efforts (e.g., a due diligence on a specific target).

This position offers substantial opportunities for scientific and commercial interactions and career advancement in the fast-moving area of rare disease.

Job Duties & Responsibilities

  • Strategic clinical development input to the Global Development Team / Subteam(s)
  • Medical Expert for a development program to the clinical study team
  • Protocol development from concept to final protocol
  • Protocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoring
  • Scientific interpretation of data from clinical studies
  • May advise other medical monitors on individual studies
  • Strategic oversight of global clinical trials/trial team (s) on assigned programs
  • Working as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project management
  • Presentation at academic congresses, investigator meetings and advisory meetings
  • Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents
  • Providing medical/scientific input to evaluate potential business opportunities

Essential Qualifications

  • MD or equivalent
  • 5-10 years of clinical experience preferably within industry (up to 5 years of industry experience may be acceptable for outstanding candidates)
  • Experience as a medical monitor for clinical trials required
  • Familiarity with early development Clinical Pharmacology studies is required
  • Regulatory experience preferred
  • Publication in peer reviewed journals
  • Excellent written / oral communication skills
  • Attention to detail and ability to think strategically
  • Willingness to take on new responsibilities
  • Interest and ability to learn about new therapeutic areas
  • Interest in career progression and ability to take on a more senior roles in 3-5 years

Preferred Qualifications

  • Board Certification preferred
  • Experience for medical responsibilities on a cross-functional team preferred
  • Basic statistical knowledge preferred

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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