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Sr. Medical Director

Sr. Medical Director

Planet PharmaAustin, TX, US
10 hours ago
Job type
  • Full-time
Job description

Sr. Medical Director

Location : Austin, TX (100% Onsite M-F)

Employment type : Full-time, Direct-Hire / Perm

Summary

A leading clinical research organization is seeking an experienced Senior Medical Director (SMD) to provide strategic medical leadership and serve as Principal Investigator (PI) or Sub-Investigator (Sub-I) across multiple therapeutic areas. This role is ideal for a research-experienced physician skilled in adult chronic disease management who thrives in a dynamic, innovative environment.

The SMD will guide clinical trial execution, ensure participant safety and regulatory compliance, collaborate with operational leaders, mentor junior investigators, and support strategic growth through partnerships and community engagement. This position offers the opportunity to drive high-quality research and contribute to the advancement of cutting-edge therapies.

Essential Duties & Responsibilities

Clinical & Research Leadership

  • Serve as PI / Sub-I on clinical trials conducted by the research center, including decentralized trials as needed.
  • Ensure the conduct of clinical trials aligns with GCP / HSP guidelines , prioritizing participant safety and data integrity.
  • Lead medical oversight for ongoing trials, including review of safety data, eligibility, and protocol adherence.
  • Review protocols and study materials; assess clinical and operational feasibility of studies.
  • Provide therapeutic and protocol-specific training to project teams and investigators.
  • Collaborate with feasibility, operations, regulatory, and data management teams to support high-quality trial execution.
  • Participate in medical review of recruitment and enrollment strategies.

Strategic & Organizational Contributions

  • Identify opportunities for new research programs, therapeutic areas, and strategic partnerships.
  • Build and maintain relationships with community physicians, healthcare organizations, and local partners to support recruitment and growth.
  • Contribute medical and scientific expertise to guide future organizational direction.
  • Participate in committees related to technology, innovation, and strategic development.
  • Conduct risk assessments to identify potential challenges in trial execution.

    • Compliance & Professional Standards

  • Maintain updated clinical expertise through ongoing professional development and conferences.
  • Ensure adherence to organizational SOPs, ethical standards, GCP guidelines, and documentation standards (ALCOA).
  • Interact with external medical experts, sponsors, and key opinion leaders as required.
  • Maintain compliance with legal, regulatory, and accreditation requirements.

    • Supervisory Responsibilities

  • Promote a culture of collaboration, scientific rigor, and continuous learning.
  • Provide mentorship and feedback to staff; monitor performance and identify improvement areas.
  • Set and communicate performance goals aligned with organizational objectives.
  • Ensure team accountability to quality, timelines, and performance standards.
  • Partner with talent and HR staff on personnel matters as needed.

    • Qualifications

  • Expert knowledge of legal and ethical standards for medical care and clinical research.
  • Strong understanding of compliance requirements, including safety reporting, informed consent, and IRB processes.
  • Fully GCP-trained with the ability to educate staff on GCP principles.
  • Excellent scientific, analytical, and problem-solving skills.
  • Strong communication skills with the ability to convey information clearly and effectively.
  • Ability to lead cross-functional teams and coordinate complex protocols with overlapping timelines.
  • Exceptional relationship-building skills with sponsors, investigators, and internal teams.
  • Highly organized, proactive, and capable of managing multiple concurrent projects.
  • Proficiency with MS Office and clinical trial data / filing systems (eSource, TMF).

    • Education & Experience

  • MD or DO from a U.S.-accredited medical school.
  • Active Board Certification required.
  • Active U.S. medical license required.
  • 8+ years of clinical experience in a U.S. community practice setting, including adult chronic disease management.
  • 2+ years of FDA clinical research experience as PI or Sub-I.
  • Experience serving as PI on GLP-1 trials lasting 12 months or longer strongly preferred.
  • Ability to travel for investigator meetings, audits, and site-related activities.
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