Zenas BioPharma
Associate Director, Clinical Scientist
Waltham, MA · Director
Sponsorship not specified$10k-$15kDetected 47 days ago
GCPCompensationClinical TrialsClinical ResearchFDA RegulatoryResearchAnimal StudiesLeadershipCommunicationWritingOrganizational SkillsBiostatisticsRegulatory Affairs
About the role
- This position ensures the scientific integrity and accurate interpretation of study data for clinical programs within the Neurology Therapeutic Area.
Responsibilities
- Contribute to the development and/or review of clinical and scientific content for core study documents, including clinical protocols, protocol amendments, informed consent forms (ICFs), investigator brochures (IBs), and clinical study reports (CSRs).
- Perform ongoing, rigorous review and interpretation of emerging clinical trial data (both subject-level and aggregate safety and efficacy data) to ensure quality, completeness, consistency, and protocol compliance.
- Support the Director, Clinical Scientist in study execution activities, serving as a key clinical science resource and subject matter expert for the study team.
- Obexelimab, Zenas' lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them.
Requirements
- Advanced scientific or clinical degree (e.g., PhD, PharmD, or equivalent clinical/scientific training).
- Demonstrated experience in clinical trial conduct, including hands-on data review, safety monitoring, and data cleaning processes.
- Strong understanding of clinical development processes, regulatory requirements, and global guidelines (FDA, EMA/EU, ICH, and GCP) and applicable standard operating procedures.
- Proven ability to work effectively and collaboratively in a fast-paced, cross-functional, team-oriented professional environment.
- Excellent communication and technical writing skills, with demonstrated experience drafting, reviewing, and editing scientific or clinical content for study-related documents and clinical protocols.
- Strong organizational skills with the ability to manage multiple priorities and drive sound results.
- Willingness to travel 10-15% of the time, including travel to key medical conferences and study-related events such as investigator meetings.
- The position is eligible for a competitive compensation and benefits package.
- Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $161,700 to $202,200. 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.
Nice to have
- Minimum of 3 to 5 years of relevant clinical research experience within the biopharmaceutical or biotechnology industry, with prior experience supporting neurology clinical trials preferred but not required.
Compensation
- The position is eligible for a competitive compensation and benefits package.
Benefits
- Contribute to the preparation, authoring, and revision of regulatory submissions and health authority responses, ensuring compliance with global guidelines.
Company info
- 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.
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