Executive Director/VP, Clinical Development
Waltham, MA, United States
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!
Position Summary:
The Executive Director/VP, Clinical Development 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 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.
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Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $290,000 to $330,000 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.
Zenas BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.
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