Position Summary:The Senior Medical Director, Clinical Development Rheumatology is a highly visible role within the organization. In this strategic role, the individual will lead the clinical development plan for one or more assets within Zenas' extensive portfolio and oversee the medical and safety responsibilities for global clinical trials across all phases of development. This individual will collaborate closely with Clinical Operations, Clinical Pharmacology, Medical and Scientific Affairs and other functions, and externally with Key Opinion Leaders and Investigators, Regulatory Authorities, Patient Advocacy Groups (PAG) and others involved in the scientific and clinical development process.
Key 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).
- interpreting clinical data and authoring 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.
Qualifications: - MD or MD/PhD in Rheumatology with a minimum of 8 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.
Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $286,686 to $307,984 USD. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas' competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.
