About the company
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Medical Director based in the United States.
Responsibilities
- Lead and contribute to clinical development strategy and execution for hematology and oncology programs, ensuring studies remain aligned with scope, budget, timelines, and strategic objectives.
- Develop, author, review, and update key clinical documents, including protocols, amendments, informed consent materials, investigator brochures, clinical study reports, manuscripts, and regulatory submissions.
- Partner with clinical operations and cross-functional teams to support successful implementation and execution of clinical trials from start-up through study completion.
- Provide medical and scientific guidance throughout clinical studies, addressing questions from investigators, study sites, ethics committees, health authorities, CROs, and internal stakeholders.
- Review, analyze, interpret, and present clinical trial data, translating findings into clear recommendations for internal and external audiences.
- Support investigator and vendor selection and develop strong relationships with key opinion leaders, investigators, academic collaborators, and external experts.
- Organize and participate in advisory boards, investigator meetings, scientific presentations, and other external-facing activities.
- Conduct or contribute to therapeutic-area research, competitive assessments, clinical strategy development, and risk-benefit evaluations.
- Train internal colleagues, CRO personnel, and study-site teams on therapeutic areas, clinical protocols, and investigational programs.
- Identify opportunities to improve clinical development processes, systems, resources, and organizational capabilities.
- Support budget planning and management, track program objectives, and maintain compliant business practices in accordance with applicable standards and regulations.
Requirements
- Advanced medical degree, preferably an MD or equivalent, with subspecialty training in hematology/oncology; exceptional candidates from other therapeutic areas may also be considered.
- 6+ years of relevant experience in biotechnology, pharmaceutical, or academic clinical development environments.
- Demonstrated experience participating in clinical development programs across multiple stages of clinical trials, ideally with experience taking at least one study from initiation through completion.
- Strong understanding of global clinical study design and the drug development lifecycle, from discovery through registration and post-marketing activities.
- Solid knowledge of Good Clinical Practice (GCP) and ICH guidelines and experience supporting clinical development policies and SOPs.
- Strong scientific, analytical, organizational, written, and verbal communication skills, with the ability to interpret and communicate complex clinical data effectively.
- Proven ability to collaborate across clinical development, operations, biometrics, pharmacovigilance, regulatory, molecular diagnostics, and translational research functions.
- Experience working effectively with global colleagues, external vendors, investigators, and academic or industry partners.
- Strategic leadership capabilities, with experience building, managing, or developing teams preferred.
- Familiarity with industry-standard clinical development technology and IT solutions.
- Strong initiative, adaptability, analytical thinking, financial awareness, and results orientation.
- Ability to foster teamwork, communicate clearly, provide actionable feedback, embrace change, and maintain a patient-focused mindset.
Conditions
- Base salary range of $299,800–$369,800 per year, depending on qualifications, experience, education, certifications, and work location.
- Eligibility for an annual bonus plan for non-commercial roles.
- Opportunity for discretionary equity awards and participation in an employee stock purchase plan.
- Medical, dental, and vision insurance.
- 401(k) retirement plan.
- Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
- Life insurance.
- Paid time off.
- Wellness benefits and programs.
- Remote work opportunity within the United States.
- Opportunity to contribute to innovative oncology programs and work with multidisciplinary, global teams.