Executive Director/VP, Clinical Development

The Executive Director/VP, Clinical Development at Zenas BioPharma is responsible for leading the clinical development plan for multiple global programs, designing clinical trials, and ensuring the safety and adherence to protocols during studies. This role requires collaborating closely with various functions within the organization and external stakeholders, including Key Opinion Leaders and Regulatory Authorities, to deliver potentially transformative therapies for autoimmune diseases.

Candidates for the Executive Director/VP, Clinical Development position at Zenas BioPharma should ideally possess an MD or MD/PhD in Rheumatology, along with 8 - 10 years of clinical development experience, especially in late-stage clinical studies. Experience in Immunology or Rheumatology is a plus, along with demonstrated leadership and communication skills, and the ability to operate in a fast-paced, collaborative environment.

Zenas BioPharma highly values candidates with extensive clinical experience in Immunology, Rheumatology, or other autoimmune disorders, along with experience leading global teams. Familiarity with working in high-demand environments and a successful track record in clinical study design and execution will set candidates apart.

Zenas BioPharma promotes a supportive and dynamic environment where transparency, relationships, urgency, excellence, and innovation are the core values. The Executive Director/VP, Clinical Development will engage in a collaborative atmosphere, surrounded by passionate professionals dedicated to advancing immunology and autoimmune therapeutics.

In the Executive Director/VP, Clinical Development role at Zenas BioPharma, the key challenges include identifying unmet medical needs in autoimmune disorders and ensuring the successful execution of complex clinical trials across various phases of development while adhering to regulatory standards and maintaining patient safety.

The salary range for the Executive Director/VP, Clinical Development position at Zenas BioPharma is between $290,000 and $330,000 USD, depending on the candidate’s experience, education, skills, and performance. In addition to base compensation, employees are also offered a comprehensive benefits package and other incentive compensation.

Zenas BioPharma seeks candidates for the Executive Director/VP, Clinical Development position who demonstrate strong leadership qualities, excellent organizational abilities, and outstanding written and verbal communication skills. A collaborative spirit and the ability to thrive in a fast-paced, evolving environment are also highly regarded attributes.

When asked about clinical study design, it’s important to articulate specific studies you have led or contributed to, explaining your role in developing study synopses, protocols, and the statistical analysis plans. Highlight your methodology, challenges faced during the process, and how you ensured adherence to GCP and patient safety.

In answering this question, share concrete examples of how you’ve conducted market research, engaged with healthcare professionals, and utilized clinical data to identify gaps in treatment. Emphasizing your collaborative approach with other departments and stakeholders will showcase your strategic thinking.

Share a relevant experience, focusing on your role in the collaboration with regulatory authorities. Discuss how you prepared for meetings, addressed regulatory queries, and facilitated submissions, highlighting how you maintained compliance and patient safety throughout the process.

Discuss your approach to networking and establishing rapport with KOLs and Investigators, including attending conferences, engaging through publications, and fostering ongoing communications. Emphasizing the importance of collaboration in designing effective clinical trials will demonstrate your proactive relationship-building skills.

Explain your methodologies for oversight in clinical trials, including your role in medical monitoring, data interpretation, and the processes you implement to address safety concerns swiftly. Providing examples of how you've navigated challenges in compliance will demonstrate your commitment to patient welfare.

Articulate the specific metrics you track to evaluate clinical program performance, such as patient enrollment rates, trial timelines, and data integrity. Emphasizing your data-driven approach to decision-making and continuous improvement will show your analytical mindset.

Provide examples of leading global teams, discussing how you managed communication, cultural differences, and ensured effective collaboration. Your ability to inspire and motivate team members across different regions will showcase your leadership skills.

Explain how a well-planned publication strategy can enhance the visibility and impact of clinical findings. Share your experience in preparing submissions for journals and conferences, as well as how you’ve collaborated with medical writing teams to ensure clear communication of results.

Share a specific example where circumstances required adapting your strategy, whether due to regulatory changes, unexpected trial data, or shifts in market demands. Elaborate on how you handled the situation and adjusted your plans while ensuring the project remained aligned with overall goals.

Discuss initiatives you've implemented to encourage innovative thinking within your teams, such as brainstorming sessions, cross-departmental collaborations, and maintaining a flexible approach to problem-solving. Highlight any successful outcomes as a result of these efforts to illustrate the impact of your leadership.