Executive Director/VP, Clinical Development
Zenas BioPharma - Waltham, MA
posted 4 days ago
About the position
Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company's pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases. We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation - TRUE Innovation!
Responsibilities
- Lead the clinical development plan and overall clinical strategy for multiple global programs.
- Help to identify unmet medical needs in autoimmune disorders.
- Overall responsibility for clinical study design, including authoring study synopses and protocols, collaborating with biostats to develop the statistical analysis plan (SAP), providing medical monitoring and safety oversight to ensure the safety of subjects and adherence to the protocol and good clinical procedures (GCP).
- Interpret clinical data and author clinical study reports (CSR).
- Develop strong relationships with Investigators, research sites and KOLs to design clinical trials that answer important medical questions.
- Support publication strategy of clinical data through preparation and submission of clinical findings to scientific journals and conferences.
- Lead clinical strategy for regulatory submissions, responses to regulatory questions and presentations at regulatory meetings.
Requirements
- MD or MD/PhD in Rheumatology with 8 - 10 years of clinical development or equivalent experience, especially in late-stage clinical studies, preferred.
- Clinical experience in Immunology, Rheumatology, or other autoimmune disorders a plus.
- Demonstrated leadership, organization, and excellent written and verbal communication skills.
- Ability to work collaboratively in a fast-paced, team-based matrix environment.
- Experience leading global teams: experience working with China is highly valued.
- Comfortable working in a demanding, fast-paced, start-up culture with evolving processes.
Benefits
- Annual performance bonus
- Equity
- Full range of benefits
- Other incentive compensation plans
