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Job

Medical Director/ Vice President, 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-CN4

  • Published:

    17 days ago

  • Expiry date:

    2021-07-30

  • Startdate:

    ASAP

Purpose of Role:

This role is NOT remote, onsite is required for the needs and tasks 

The Medical Director is responsible for the development of clinical research strategies and direction of Phase 1-3 clinical studies while working with cross-functional project teams. S/he will be responsible for study design, development, data readout, and summary. This position will also provide ongoing input into the assessment and interpretation of safety data and contribute to investigator training.

Key Tasks & Responsibilities:

  • In-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale.

  • Provide clinical/scientific input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high-value clinical endpoint insight for future critical decisions.

  • Collaborate with external opinion leaders, Principal Investigators, and clinical operations personnel to ensure appropriately designed studies are successfully implemented.

  • Familiarity with concepts of clinical research and clinical trial design, including biostatistics.

  • Support the development of key scientific relationships with external opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings.

  • Possible Medical Monitor responsible for the safety monitoring of clinical trials, and as the medical expert for clinical studies.

  • Preparation of abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).

  • Conduct medical assessment and disposition of adverse events (in conjunction with Drug Safety Physician) and evaluate safety of clinical compounds prior to and during ongoing clinical studies.

Professional Skills & Experience:

  • MD degree with accredited residency training and board certification in relevant clinical specialty for the therapeutic area required.

  • 2 to 10 years experience in pharmaceutical and/or biotechnology industry developing investigational new drugs or experience in a clinical research organization involved in clinical trials.

  • Experience with drug development in metabolic diseases (experience or knowledge of orphan disease drug development a plus).

  • Ability to analyze and interpret clinical safety and efficacy data and develop written reports and presentations of those data.

  • Review and interprets scientific knowledge of competitor landscape (molecule / indication).

  • Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience with FDA and other health authorities strongly desired.

Skills and Attributes

  • The successful candidate will read, write, and speak fluent English, possess excellent communication skills, and will be capable of articulating the Company’s clinical and regulatory strategies and progress to the Senior Management Team.

  • Must have the ability and strong desire to be “hands-on.” with a positive, can-do attitude.

  • Availability to participate in early or late meetings/teleconferences.

  • Ability and strong desire to work in a dynamic “start-up” environment and be able to travel domestically and/or internationally.

  • Excellent interpersonal and influencing skills. This includes a demonstrated ability to use an open and supportive communication style and to work cross-functionally with multiple corporate sites, teams, and personalities.