Medilink Therapeutics

<ul>
<li>Manage the design and implementation of one or more clinical development programs in support of an overall Product Development Plan. Oversee project-related education of investigators, study site personnel, and internal study staff.</li>
<li>Provide medical oversight and safety monitoring for ongoing clinical trials including participation in SAE reporting. Review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.</li>
<li>Establish and approve scientific methods for the design and implementation of applicable clinical protocols, data collection systems, and final reports.</li>
<li>Responsible for scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, publications, and other program related documents.</li>
<li>Provide in-house clinical expertise with internal stakeholders. May participate in business development activities as required by program needs.</li>
<li>Act as a clinical leader to actively interact with key opinion leaders related to the molecule and disease area.</li>
<li>Participate in appropriate regulatory discussion and activities (i.e. the filing of IND and NDA). Responsible for understanding the regulatory requirements related to clinical studies and complying with those requirements.</li>
<li>Ensure adherence to the highest level of Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting clinical study.</li>
</ul>
Qualifications
<ul>
<li>Doctor of Medicine degree (M.D. or internationally recognized equivalent degree), PhD, or Pharm. D is required. Completion of a subspecialty fellowship and/or residency program is strongly preferred.</li>
<li>At least 2 years of clinical trial experience in the pharmaceutical industry. Preferred 3+ years direct experience in oncology development in MNC (multinational company).</li>
<li>Strong analytical and communication skills. Ability to interact externally and internally to support a global scientific and business strategy.</li>
<li>Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.</li>
<li>Must possess excellent oral and written English communication skills.</li>
</ul>
This role requires the incumbent to travel up to 30% of the time.
Job Type: Full-time
Pay: $200,000.00 - $330,000.00 per year
Benefits:
<ul>
<li>401(k)</li>
<li>401(k) matching</li>
<li>Dental insurance</li>
<li>Employee assistance program</li>
<li>Flexible schedule</li>
<li>Flexible spending account</li>
<li>Health insurance</li>
<li>Health savings account</li>
<li>Life insurance</li>
<li>Retirement plan</li>
<li>Vision insurance</li>
</ul>
Work Location: Remote

Clinical Development Physician

Clinical Development Physician

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