Scientist/Sr. Scientist, Clinical Pharmacology

Responsibilities

• Contributes to clinical development strategies of pipeline products across various therapeutic areas and design of clinical studies with some supervision under supervision
• Collaborate closely with preclinical, clinical, regulatory, biostatistics, and medical affairs teams to drive drug development programs and contribute to trial designs, dosing strategies, and regulatory submissions and interactions with health authorities
• Lead the design, validation, and implementation of pharmacometric models to inform decision-making at various stages of drug development
• Conduct modeling and simulation work on PopPK, ER, PK/PD or exploratory analyses and guides PK/PD modeling or simulations as appropriate and to guide study design, inform dose selection and optimization, and efficacy/safety assessments
• Utilize modeling software such as NONMEM®, R, or other relevant tools to perform data analysis and generate modeling results
• Manage data analysis, interpretation, and reporting with some supervision
• Evaluate and apply new data and data analyses to refine studies in the development plan
• Stay current with the latest advancements in pharmacometric methodologies, applying innovative techniques to enhance modeling practices
• Integrate all available data (both clinical and nonclinical data) to clinical development strategy from CP point of view
• Mentor and guide junior pharmacometricians, fostering a culture of continuous learning and development within the team
• Carry out functional responsibilities in accordance with applicable SOPs and regulatory requirements

Qualifications

• Ph.D., Pharm.D., or equivalent with minimum 2 years of relevant experiences; or MS or equivalent with minimum 4 years of relevant experience; or equivalent level of expertise and experience
• Postdoctoral experience, hospital experience, and industry experience are preferred
• Proficient in developing NCA analysis, PopPK, PK/PD, ER analysis, model informed drug development (MIDD) principles, and data visualization, results interpretation and reporting
• Proficiency in modeling software such as NONMEN, R, WinNonlin, Phoenix, etc
• Good knowledge and experience of drug development in one or multiple TAs
• Critical thinking skills, with keen scientific and development judgment
• Self-motivated performance and working on teams and in a matrix environment
• Able to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner
• Able to work independently and collaboratively in a multidisciplinary team
• Strong problem-solving skills and ability to meet deadlines in a fast-paced environment
• Excellent communication, presentation, and interpersonal skills

Pay & Benefits

The expected base salary range for this position is $90,000 - $140,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s level qualifications, experience, and skills. While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.

SystImmune offers a comprehensive benefits package including:

• 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years
• 15 PTO days per year, sick leave, plus 11 paid holidays

We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.