- Senior
- Ufficio in Waltham
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:
Zenas is currently looking for Director of DMPK reporting to Head of Nonclinical Development. This highly motivated and experienced individual will lead Zenas drug metabolism and pharmacokinetics (DMPK) functions. The successful candidate will be responsible for developing and executing DMPK strategies across all preclinical- and clinical-stage development candidates. This individual will serve as the hands-on scientific and strategic leader all nonclinical aspects for drug absorption, distribution, metabolism, and excretion (ADME) following available regulatory guidance from global regulatory agencies. He/She will be working closely with cross-functional teams including Toxicology, Clinical Pharmacology, Regulatory Affairs, and Program Management to advance and expand our pipelines. The role requires strong scientific expertise, leadership skills, and proven experience in a fast-paced biotech environment by managing external CROs and collaborating closely with internal project teams.
Key Responsibilities:
- Define and execute DMPK strategy and plans across all development candidates at preclinical, early and late clinical development phases
- Design and execute preclinical ADME/PK studies via an outsourcing model working closely with service providers such as CROs and interpret study data for DMPK findings as a scientific leader
- Represent DMPK on a variety of interdisciplinary teams
- Manage CROs and collaborate with cross-functional teams by providing DMPK data package in a timely fashion.
- Author and review regulatory documents for submission such as INDs, CTAs, NDAs etc.
Qualifications:
- PhD in Pharmacokinetics, Pharmaceutical Science or related discipline with 6+ years biopharma experience (or 10+ years with MS/BS degree).
- DMPK expertise in small molecules and biologics. Other novel modalities are preferred but not required.
- Strong leadership, communication, and cross-functional collaboration skills.
- In-depth knowledge and understanding of DMPK principles; strong hands-on experience with relevant DMPK tools such as WinNonlin
- Experience with regulatory interaction and submissions
#LI-Hybrid
Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $180,000 to $225,000. 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.
