Job Summary

Vivace Therapeutics Inc. is a privately held, clinical-stage precision oncology company developing VT3989, a potential first-in-class TEAD inhibitor for the treatment of mesothelioma and other cancers. Reporting to the Vice President of Program Management, the Senior Director will lead and execute the clinical pharmacology and ADME/DMPK strategy across the VT3989 program. This individual will provide scientific and regulatory leadership to support late-stage development activities, including Phase 2/3 studies and NDA-enabling efforts.

Key responsibilities include:

• Driving clinical pharmacology and ADME/DMPK strategy across the program
• Initiating and overseeing outsourced studies
• Leading execution and interpretation of clinical pharmacology and ADME/DMPK activities
• Guiding program decisions through PK/PD, translational, and exposure-response analyses
• Developing and implementing global clinical pharmacology regulatory strategies
• Communicating scientific plans, rationale, and progress to senior leadership
• Collaborating cross-functionally with clinical development, operations, regulatory, translational sciences, and external partners

The ideal candidate is a collaborative and strategic scientific leader with deep expertise in clinical pharmacology, drug metabolism, pharmacokinetics, ADME, and translational modeling. This individual thrives in a fast-paced biotech environment and demonstrates strong leadership, communication, and cross-functional collaboration skills.

The successful candidate will have extensive experience supporting small molecule drug development from pre-IND through Phase 3 and NDA submission. The incumbent will be responsible for developing comprehensive clinical pharmacology plans and data packages to support global regulatory filings and health authority interactions.

Candidates should embody the company values of Vision, Value, Conviction, and Experience, and contribute to a transparent, accountable, and execution-focused culture dedicated to improving the lives of patients with cancer.

Position Responsibilities

• Develop and execute integrated clinical pharmacology plans across the VT3989 program, including for clinical combination studies with approved agents or other oncology drugs in clinical development
• Design, oversee, and interpret:
• Drug-drug interaction studies
• QT/QTc studies
• Hepatic and renal impairment studies
• Exposure-response analyses
• Population PK analyses
• Provide scientific leadership for PK/PD and translational strategies
• Oversee and interpret in vitro and in vivo ADME/DMPK studies, including:
• Metabolic stability
• CYP inhibition and induction
• Transporter assessments
• Bioavailability
• Protein binding
• Metabolite identification and characterization
• Tissue distribution
• Serve as the subject matter expert for global regulatory interactions related to clinical pharmacology and ADME/DMPK
• Support regulatory submissions, health authority responses, and meeting preparation
• Author and review clinical pharmacology and ADME/DMPK content for investigator brochures, regulatory briefing documents, DSURs, INDs, and NDAs
• Manage external CROs, consultants, and strategic collaborators supporting clinical pharmacology and ADME/DMPK activities
• Contribute to establishing scientific best practices and operational standards across the organization

Education / Experience / Skills

• PharmD, PhD, or equivalent degree in Clinical Pharmacology, Pharmacology, Pharmaceutical Sciences, Drug Metabolism, or a related discipline
• 10+ years of biotechnology or pharmaceutical industry experience
• Deep expertise in:
• Small molecule drug development
• Clinical pharmacology
• ADME/DMPK
• PK/PD modeling and simulation
• Translational sciences
• Dose optimization
• Demonstrated experience supporting IND and NDA submissions, and direct experience in interacting with regulatory agencies to align clinical pharmacology strategies
• Strong understanding of FDA and global regulatory expectations for clin pharm programs
• Proven experience managing external vendors, CROs, and cross-functional collaborations
• Excellent leadership, communication, and interpersonal skills
• Ability to work effectively in a lean, fast-paced biotechnology environment

Location

San Mateo, CA. Presence in the office is expected at least four days per week (Monday-Thursday).

For candidates based outside the Bay Area, a hybrid schedule that includes at least three days per month in the office may be considered.

About working at Vivace Therapeutics

We are seeking motivated, passionate, and talented individuals to join our small but highly effective and dynamic team. We are advancing innovative therapies targeting the Hippo/YAP/TEAD pathway, a promising approach for treating tumors such as mesothelioma and potentially enhancing the activity of other targeted therapies, including EGFR, KRAS, and MEK inhibitors. Our clinical data has demonstrated benefit in mesothelioma patients who were refractory to both immunotherapy and chemotherapy, and we are now advancing into Phase 3 development. This is a unique opportunity to make a meaningful impact in a collaborative, fast-paced environment as we pursue our mission of helping people fight cancer and live life to the fullest.

We offer employees competitive compensation, including salary, target bonus, equity, and a comprehensive benefits package that includes medical, dental, vision, and life insurance; generous paid time off; flexible spending accounts for healthcare and dependent care expenses; and a 401(k) retirement savings plan.