HEAD OF CLINICAL DEVELOPMENT

JOB FUNCTION: Scientific
JOB TYPE: Direct Hire
LOCATION: Boston, MA

COMPENSATION: $275k - $350k
MINIMUM EDUCATION: PhD
POSTED: Sep 14, 2021

Our client is a growing muscle therapeutics organization that is developing treatments to improve the lives of those living with rare or genetic muscle diseases. They are currently hiring a Head of Clinical Development.

Salary/Hourly Rate:

$275,000 – $350,000

Position Overview:

The Head of Clinical Development will guide clinical operations by providing direction and leadership to internal teams. The right candidate will act as a subject matter expert for the clinical and medical aspects, and will work closely with a cross-functional team to streamline the clinical development process in accordance with the overarching development strategy of relevant products.

Responsibilities of the Head of Clinical Development:

  • Oversee trials in clinical development
  • Advise on clinical regulatory guidelines for each of the clinical programs
  • Work closely with internal and external teams to execute clinical trial strategy and design
  • Manage pharmacovigilance and drug safety activities for ongoing trial(s)
  • Help prepare clinical portions of regulatory filings, including IND submissions, clinical study reports, efficacy summaries, and protocols/protocol amendments
  • Foster initial and continuing relationships with CROs and other external vendors
  • Provide leadership and guidance for the clinical development team

Qualifications for the Head of Clinical Development:

  • 10+ Years of relevant experience in the biotech/pharmaceutical industry in a directly related discipline
  • Demonstrated experience designing and executing clinical trials
  • Experience working with CRO collaborators including technology transfer of assays, qualification of vendors, and vendor quality management
  • Comprehensive knowledge of assay development, qualification, and validation of biomarker and bioanalytical assays under all applicable guidelines
  • Previous management experience with the established ability to manage multiple projects and programs simultaneously

Education Requirements:

  • Ph.D., Pharm.D., or M.D. required

Benefits:

  • Atrium Care package available, upon eligibility

As a woman owned firm, we value diversity. We are an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, genetic information or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

POSITION ID: 100960

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