Medical Director, Clinical Development — Remote/Hybrid

Kailera Therapeutics

United States

Hybride

USD 242 000 - 290 000

Plein temps

14 jours+

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Avantages offerts par ce poste

Health coverage
Wellness stipend
401(k) match
Tuition reimbursement
Commuter benefits
Equity grants
Annual bonus opportunities

Résumé du poste

Kailera Therapeutics is seeking a Medical Director, Clinical Development to design and execute clinical development programs across multiple studies, providing medical leadership in a fast-paced biotech setting.

This hub-based role offers Waltham, MA onsite 3–4 days per week or remote with a hub visit once a month. You will collaborate with Regulatory, Safety, CMC, Translational Science, and external KOLs to advance our obesity-focused pipeline.

Qualifications

  • 2+ years in clinical development; biotech or small pharma preferred.
  • Hands-on trial design and execution experience.
  • Regulatory submissions and global filings experience.
  • Understanding of GCP, trial design, regulatory requirements, and safety monitoring.
  • Excellent written and verbal communication; regulatory document writing.

Responsabilités

  • Medical monitoring, safety activities oversight.
  • Lead design and execution of clinical development strategies across studies.
  • Serve as the medical contact for clinical/medical issues.
  • Interpret, report, and prepare results of product research with senior clinical staff.
  • Act as medical expert for assigned assets studies.
  • Contribute to regulatory interactions and strategy (IND/CTA/NDA).
  • Collaborate with Clinical Operations for site selection and patient recruitment.
  • Oversee data interpretation and clinical study reports.
  • Work with Regulatory, Safety, CMC, Translational Science.

Connaissances

Clinical development
Regulatory submissions
Cross-functional collaboration
GCP knowledge
Written communications

Formation

MD or equivalent

Description du poste

Kailera Therapeutics is seeking a Medical Director, Clinical Development to design and execute clinical development programs across multiple studies, providing medical leadership in a fast-paced biotech setting.

This hub-based role offers Waltham, MA onsite 3–4 days per week or remote with a hub visit once a month. You will collaborate with Regulatory, Safety, CMC, Translational Science, and external KOLs to advance our obesity-focused pipeline.

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