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Job

Senior Medical Director, Clinical Development

  • Location

    San Diego

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    $250,000 - $350,000

  • Contact:

    Cyrus Nazari

  • Contact email:

    c.nazari@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    #LI-CN2

  • Published:

    about 1 month ago

  • Expiry date:

    2021-07-30

  • Startdate:

    ASAP

Medical Director

Location: San Diego, CA, US

Department: Clinical Development

Employment Type: Full Time

 

Medical Director/Senior Director, Clinical Development

· San Diego, California

We are looking for a Medical Director/Senior Director of Clinical Development who will drive the clinical development of portfolio products for the company. This person will be responsible effective medical and scientific oversight of clinical studies and support core drug development efforts.

This company is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. Top project is using next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors. 

 

ROLE RESPONSIBILITIES

  • Drive execution of clinical trial plans to deliver compelling safety, pharmacokinetic, and efficacy data supportive of regulatory and marketing proof-of relevance

  • Contribute to company scientific and clinical strategy by setting appropriate clinical objectives and priorities

  • Implement and oversee all aspects of clinical trial conduct (regular physician calls, review of safety data, etc.)

  • Closely collaborate with the clinical operations team/study team to ensure the integrity of medical and scientific aspects during clinical study execution, analysis, and reporting

  • Work with clinical operations/study team to select and manage CROS’ study sties, and supporting services (central laboratory, biostatistics, etc.) to support clinical development of investigational agents

  • Primary contact with external investigators and internal study team for questions relating to clinical/medical aspects of the protocol.

  • Lead in the analysis and interpretation of clinical trial data and the reporting of clinical trial results

  • Adhere to critical timelines and direct the activities of team members, collaborators, clinical sites, and clinical investigators to meet required deadlines and target goals

  • Develop, write, and review clinical protocols and Investigator’s Brochures.

  • Collaborate with the research team and external investigators to expand or refine target patient populations.

  • Contribute to regulatory strategy and the preparation of clinical sections for all regulatory filings (IND, Annual reports, AE/SAE reporting, study reports, etc.

  • Crafting, reviewing, and approving clinical reports and presentations for internal and/or external purposes

  • Influence collaborators and consultants by demonstrating a deep understanding of all aspects of company’s projects, data, results, and objectives.

 

QUALIFICATIONS

  • MD. or MD/PhD with board certification

  • 3+ years of pharmaceutical and/or biotechnology experience in medical monitoring of clinical trials, oncology experience required

  • Knowledge of regulatory guidance for the conduct of human clinical trials in the U.S. (FDA) and EU (EMA)

  • Experience presenting to a wide variety of audiences including internal teams, and medical and scientific communities.