Medical Director

Alpha Clinical Development; United States; Hybrid; USD 250,000 - 350,000; Full time

Job summary

A leading clinical research organization in the United States is seeking an experienced Medical Director to lead clinical development in oncology trials. This role involves overseeing study execution, regulatory submissions, and providing strategic input across cross-functional teams. An MD with a strong background in oncology and demonstrated leadership in clinical trials is essential. The candidate will also represent the organization at scientific conferences and engage with regulatory affairs.

Qualifications

• Proven experience leading early- and late-stage clinical trials in oncology.
• Strong understanding of global regulatory guidelines and safety protocols.
• Direct involvement in successful regulatory filings (IND, NDA, BLA).

Responsibilities

• Provide medical leadership across clinical development programs.
• Oversee medical aspects of ongoing clinical studies.
• Contribute to statistical analysis of clinical trial outcomes.

Skills

Leadership in clinical trials

Oncology expertise

Regulatory knowledge

Scientific communication

GCP and ICH guidelines

Collaboration in cross-functional teams

Education

MD with board certification in Oncology or Hematology

Job description

We are seeking a highly experienced and motivated Medical Director to provide medical and scientific leadership across clinical development programs from Phase 1 through Phase 3. The Medical Director will play a key role in the strategic planning, design, execution, and interpretation of clinical trials, as well as in regulatory submissions and cross-functional collaborations. The ideal candidate will bring a strong background in oncology, with experience in both early- and late-stage clinical development. A deep understanding of solid tumor malignancies and, ideally, hematologic oncology (including myeloma) is preferred. The position requires exceptional scientific acumen, regulatory awareness, and leadership within a fast-paced, cross-functional environment.

Clinical Development Strategy

• Provide strategic input into the design and execution of clinical development plans and clinical trials in oncology.
• Serve as the medical lead on cross-functional product teams, guiding clinical and scientific direction.
• Support clinical trial site identification, investigator engagement, and relationships with KOLs, professional societies, and advocacy groups.

Trial Execution

• Oversee medical aspects of ongoing clinical studies, including real-time review of safety and efficacy data.
• Lead the development, review, and approval of study protocols, investigator brochures, and related clinical documents.
• Collaborate with Clinical Operations, Biostatistics, Regulatory, and other teams to ensure timely and high-quality study delivery.

Data Analysis and Reporting

• Contribute to statistical analysis of plans and interpretation of trial outcomes.
• Lead the preparation and review of clinical study reports, abstracts, congress presentations, and manuscripts.

Regulatory and Safety

• Partner with Regulatory Affairs to support global regulatory interactions (e.g., FDA, EMA, PMDA) and submissions (IND, NDA, BLA).
• Collaborate with Safety/Pharmacovigilance to assess safety data, support DMCs, and prepare required safety updates (e.g., DSUR).

Scientific Communication

• Represent the organization at scientific and medical conferences, presenting study data and insights.
• Provide clinical input for external collaborations and business development activities.

Requirements

• MD with board certification or eligibility in Oncology, Hematology, or related subspecialty.
• Proven experience leading early- and late-stage clinical trials and providing medical oversight in a global setting.
• Strong understanding of GCP, ICH, and global regulatory guidelines.
• Demonstrated leadership and ability to work collaboratively in cross-functional teams.
• Excellent communication skills, with proficiency in scientific writing and medical data presentation.
• Experience with novel therapeutic modalities (e.g., immuno-oncology, ADCs, cell or gene therapy).
• Direct involvement in successful regulatory filings (IND, NDA, or BLA).
• Familiarity with biomarker-driven and translational medicine.