6 12 Month Contract | Global Clinical Development
Our client is seeking an accomplished Senior Medical Director Consultant to provide strategic medical leadership within the Early Clinical Development Oncology organization on a 6 12 month contract. This consulting role will support the development and execution of global oncology clinical programs spanning early and late-stage development.
The ideal candidate is a board-certified oncologist with deep expertise in either hematologic malignancies or solid tumors and a demonstrated track record leading global clinical development programs across Phase I, II, III, and IV clinical trials.
This individual will partner with cross-functional global teams to provide scientific, medical, and strategic leadership in the design, execution, monitoring, analysis, and interpretation of oncology clinical studies while ensuring patient safety, scientific excellence, and regulatory compliance.
- Provide medical leadership for global oncology clinical development programs across Phase I, II, III, and IV clinical trials.
- Lead the medical strategy, design, and execution of clinical trial protocols supporting early and late-stage development programs.
- Serve as the Medical Monitor for assigned clinical studies, providing oversight of patient safety, protocol adherence, eligibility assessments, and emerging safety signals.
- Collaborate with Clinical Operations, Regulatory Affairs, Biometrics, Translational Medicine, Pharmacovigilance, Medical Affairs, and other cross-functional stakeholders to ensure successful study execution.
- Contribute to clinical development plans, target product profiles, and overall program strategy.
- Analyze and interpret clinical efficacy, safety, pharmacokinetic/pharmacodynamic, and biomarker data to support key development decisions.
- Prepare and review clinical study reports, investigator brochures, regulatory submissions, scientific publications, abstracts, and presentations.
- Support interactions with global regulatory agencies and contribute to regulatory submissions and responses.
- Develop and maintain relationships with key opinion leaders, investigators, and academic collaborators.
- Represent clinical programs at investigator meetings, advisory boards, and scientific congresses.
- Ensure all clinical activities comply with ICH-GCP guidelines, applicable regulatory requirements, and company SOPs.
- MD or DO required.
- Board certification in Medical Oncology or Hematology/Oncology.
- Minimum of 10 years of pharmaceutical, biotechnology, or clinical drug development experience in oncology.
- Demonstrated expertise in either:
- Hematologic malignancies, or
- Solid tumor oncology.
- Extensive experience leading global Phase I, II, III, and IV oncology clinical trials.
- Proven experience serving as a Medical Monitor for oncology studies.
- Strong understanding of oncology drug development, clinical trial methodology, regulatory requirements, and Good Clinical Practice (GCP).
- Experience collaborating with global regulatory agencies, including FDA and EMA.
- Ability to interpret complex clinical and scientific data and translate findings into development strategy.
- Outstanding communication, leadership, and cross-functional collaboration skills.
- Ability to work independently in a fast-paced, matrixed global environment.
- Fifteen or more years of clinical and/or biopharmaceutical industry experience.
- Experience in Early Clinical Development, including first-in-human, dose-escalation, and proof-of-concept studies.
- Experience in immuno-oncology, targeted therapies, antibody-based therapeutics, cell therapy, or precision medicine.
- Previous experience supporting regulatory filings, including NDA and/or BLA submissions.
- Established relationships with global oncology investigators and key opinion leaders.
- Position: Senior Medical Director Consultant
- Duration: 6 12 months
- Therapeutic Area: Oncology
- Function: Early Clinical Development
- Clinical Trial Scope: Global Phase I, II, III, and IV studies
- Work Arrangement: Remote or hybrid (based on project needs)
- Travel: Approximately 15 25% for investigator meetings, scientific congresses, and internal team meetings.
The successful consultant is a seasoned physician leader with extensive experience in global oncology drug development and a passion for advancing innovative therapies. This individual is a strategic thinker who thrives in a collaborative, cross-functional environment and brings the clinical expertise necessary to lead complex global development programs from early clinical research through late-stage development.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
