RA Capital

This role is responsible for providing strategic leadership and scientific expertise in clinical pharmacology and drug metabolism and pharmacokinetics (DMPK) to guide drug development programs from early discovery through late-stage development and commercialization. Provide integrated Clinical Pharmacology and DMPK plans for late-stage discovery and clinical projects to ensure effective clinical pharmacology strategies. Execute related DMPK and clinical pharmacology studies and interpret study results to provide timely and high-quality clinical pharmacology and DMPK support to various portals and milestones. This requires collaboration cross-functionally as well as with external KOLs, consultants, and collaborators.

Duties and Responsibilities:

• Develop and implement comprehensive clinical pharmacology and DMPK strategies for drug development programs, ensuring alignment with therapeutic area and patient population.
• Represent clinical pharmacology and DMPK expertise on cross-functional project teams and with external stakeholders.
• Advocate for and implement model-informed drug development (MIDD) principles across the organization.
• Design and interpret clinical pharmacology studies, including pharmacokinetic (PK) and pharmacodynamic (PD) studies.
• Provide expert guidance on dose selection and optimization at all stages of clinical development based on nonclinical and clinical data.
• Lead the development of clinical pharmacology plans and content for clinical and regulatory documents e.g., study protocols, study reports, IBs, DSURs/PSURs, INDs, NDAs, MAAs) and address Clinical Pharmacology-related regulatory questions.
• Collaborate with cross-functional teams (e.g., clinical development, safety, regulatory) to ensure seamless integration of clinical pharmacology and DMPK activities.
• Actively engage in project and study level team discussions to provide Clinical Pharmacology and DMPK expertise to ensure adequate functional input.
• Stay abreast of advancements in clinical pharmacology and DMPK science.
• Contribute to the development of company-wide policies and procedures related to clinical pharmacology and DMPK.

Qualifications and Skills:

• PhD. in Pharmacology, Pharmaceutical Sciences, or related field or Pharm D.
• A minimum of 15 years of relevant industry experience in the field of oncology drug development.
• Hands-on experience serving as clinical pharmacology lead for various types of clinical pharmacology studies, preferably with small-molecule, oral oncology therapeutics from IND-enabling studies through Phase 1 clinical development.
• Hands-on experience developing PK/PD strategy for early-stage oncology programs.
• Thorough understanding of DMPK and clinical pharmacology principles and methodologies in support of early to late-stage projects.
• Experience with model-informed drug development (MIDD) is highly desirable.
• Familiarity with common software, e.g., WinNonlin, NONMEM, etc.
• Strong understanding of regulatory requirements for clinical pharmacology and DMPK studies.
• Direct experience interacting with FDA and EMA.
• Hands-on experience with clinical and regulatory documents including NDA, MAA, IND, IB, CSR, etc.
• Excellent communication, interpersonal, and presentation skills.
• Ability to successfully work remotely and travel ~10%.

Other Information:

NiKang currently anticipates the annual base salary range for this Senior Director-level role is estimated to be from $275,000 to $300,000. Our job titles span more than one career level. The actual title for this role and final salary amount offered to a successful candidate may be higher or lower than the estimated range and will depend on several factors that include, but are not limited to, the geographic location of the candidate, the type and length of applicable experience, education, and other relevant factors. In addition to base salary, the hired applicant for this position will be eligible to receive an annual discretionary bonus and potential equity awards based on factors such as individual and organizational performance. NiKang offers a comprehensive benefit plan to eligible employees, including eligibility to participate in a company-sponsored 401(k) program, Paid Time Off benefits, eligibility for medical, dental, vision benefits, flexible benefits, short-term disability and life insurance benefits. NiKang reserves the right to amend, modify, or terminate its compensation and benefit programs at its sole discretion.

The statements contained herein are intended to describe the general nature and level of work to be performed. The statements are not to be construed as a complete and/or definitive list of the responsibilities, duties, and skills required of the employee. Furthermore, they do not imply a contract for employment and are subject to change with or without notice at the discretion of the employer.