Company:  Confidential

Job Title: Senior Medical Director/Director

Job Number: 25036

Location: Cambridge, MA

Job Description

We are seeking a creative translational medicine expert to develop and execute the clinical development plans for the company. This key position with be responsible for evaluating the current Hematopoietic Stem Cell Transplantation landscape and building the translational science strategy for Magenta’s novel drug development programs. The successful candidate will identify and develop relationships with key opinion leaders, patient advocacy groups, academic institutes and hospitals to integrate novel advances in transplantation research into the drug development process and clinic.

Responsibilities

You are perfect for this role if you are engaged by and want to be responsible for:

  • Leading the clinical development strategy and be accountable for the execution of the translational medicine effort within the company
  • Collaborating closely with internal research team to integrate translational research into development and clinical strategies
  • Developing and maintain relationships and serve as the main medical liaison with key opinion leaders and Principal Investigators
  • Leading internal and external team members, vendors and consultants to develop an IND package, as well as review and evaluate pre-clinical safety data for regulatory submission
  • Being responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reports
  • Organizing and present at relevant clinical advisory boards, DMC’s and medical/scientific meetings
  • Supporting business development process by providing medical expertise for in- or out-licensing, partnering and acquisition activities
  • Traveling, as needed, nationally and internationally

Required Skills

We would be thrilled if you brought the following with you:

  • MD with research experience or an MD / PhD, as well as a fellowship in Hematology/ Oncology or related areas
  • Several years of clinical experience in stem cell transplantation within academic medical, pharmaceutical and/or biotechnology sectors
  • Extensive experience in translational or clinical research related to drug development is required: biotech/ pharma experience favorably considered
  • Experience with developing regulatory strategy, including experience with IND-enabling, Phase I and Phase II studies preferred
  • Broad therapeutic area and target class expertise and experience in one of the following; Hematology/ Oncology, Auto-immunity and/ or Hematological Rare Genetic Diseases
  • Ability to identify and build relationships with thought leaders and leading clinical centers
  • Strong academic record with high quality peer-reviewed publications that demonstrate research productivity and the ability to perform cutting edge research in stem cell biology/transplantation and/or gene therapy
  • Effective communications (verbal & written) and presentation skills are essential
  • Track record of effective cross-collaboration within an organization, among teams, and external groups/organizations
  • Management experience of direct reports is preferred

 

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