Clinical Director Jobs

About The Position

Requirements

• MD; oncology training is preferred.
• At least 7 years of clinical development experience in the pharmaceutical or biotechnology industry and/or an academic or other clinical trial setting.
• Extensive experience applying data analysis, interpretation, and clinical relevance principles and techniques in the pharmaceutical or biotechnology industry.
• Experience independently generating trial designs; writing or amending protocols and informed consent forms; constructing appropriate case report forms; and coordinating cross-functionally.
• In-depth therapeutic-area expertise and relevant clinical trial experience, or clear ability to adapt using transferable skills.
• Strong knowledge of medical aspects of GCP, ICH, FDA, EMA, and other relevant guidelines and regulations.
• Proven ability to work effectively in cross-functional drug development teams and integrate multiple perspectives into a clinical development plan.
• Experience authoring regulatory briefing materials and responses to health authority questions, and contributing to regulatory strategy and cross-functional coordination.
• Demonstrated success driving study-level cross-functional strategy, including study design, feasibility, timeline and budget projections, and protocol amendments; able to drive discussions in internal decision-making forums.
• Ability to build relationships with external key opinion leaders and contribute to advisory boards, individual engagements, and steering committees.
• Experience engaging investigators to optimize trial conduct, including presenting at investigator meetings, or clear ability to do so.
• Strong teamwork, leadership, communication, and interpersonal skills, including the ability to inspire, motivate, and mentor diverse teams.
• Experience mentoring clinical scientists and experience or clear potential as an effective line manager.
• Expertise in building and maintaining internal and external stakeholder relationships.
• Strong strategic thinking and analytical skills, including making data-driven decisions, recognizing trade-offs, and setting priorities in a fast-paced environment.
• Strong written communication and business presentation skills.
• Passion for innovation and commitment to developing therapies that make a meaningful difference in patients' lives.
• Demonstrated strong leadership presence, adaptability, and flexibility.
• Ability to anticipate needs and assess and manage business and organizational risks.

Nice To Haves

• Experience or understanding of early-phase drug development.
• Significant contributions to the conception, conduct, and delivery of clinical development plans, including alignment with scientific governance.
• Experience enhancing or developing core and sub-team processes, structures, systems, tools, and other resources in the pharmaceutical or biotechnology industry.
• Experience leading or supporting clinical development contributions to major regulatory submissions, such as INDs for first-in-human studies, EOP2 briefing books, PIP/PSP, label negotiations, Breakthrough Therapy Designation, or Accelerated Review.
• Ability to present clinical development aspects of programs to major health authorities, such as the FDA and EMA, in person or by teleconference; experience leading health authority interactions.
• Ability to establish clinical development strategy for CTA/EC submissions and responses to health authority questions.
• Collaborative experience on enterprise-level strategic initiatives with internal and external partners, including investigators, clinicians, scientists, KOLs, development, research, business development, commercial, and legal teams, with demonstrable outcomes.
• Influential and inspiring leadership, including the ability to bring teams and individuals along.
• Demonstrated courage, conviction, and conflict-resolution skills.

Responsibilities

• Lead clinical science and medical aspects of clinical development strategy and clinical documentation.
• Represent the clinical development plan on relevant teams, sub-teams, and forums.
• Oversee training of study site personnel and serve as the primary program-level contact for clinical development plan questions.
• Oversee medical and safety data reviews and study reporting.
• Lead clinical development activities for complex, high-priority strategic studies with independence and self-directed leadership.
• Align cross-functional efforts with scientific, regulatory, and commercial objectives while executing the clinical development plan.
• Lead, mentor, and contribute to a high-performing cross-functional clinical development team.
• Oversee clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.
• Establish and maintain relationships with clinical investigators, regulatory agencies, and key stakeholders.
• Gather, analyze, and interpret clinical data to provide strategic insights and guide program development.
• Manage clinical development timelines, resource allocation, and milestone achievement.
• Stay abreast of scientific advancements and regulatory trends in clinical development.
• Potentially manage multiple direct reports.

Benefits

• Competitive cash compensation
• Robust equity awards
• Strong benefits
• Learning and development opportunities