Senior Principal Scientist/Associate Director - Oncology PKS

Novartis Farmacéutica; Cambridge (MA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

An established industry player is looking for a Senior Principal Scientist/Associate Director to lead innovative PK Sciences initiatives. This role offers the chance to develop and implement DMPK and clinical pharmacology strategies, bridging the gap between discovery and clinical application. The ideal candidate will have a Ph.D. or Pharm.D. and over a decade of experience in the pharmaceutical industry, particularly in PK and clinical pharmacology. Join a dynamic team that plays a crucial role in bringing transformative medicines to patients, fostering a collaborative environment where your expertise will directly impact patient care and therapeutic advancements.

Qualifications

• 10+ years in pharmaceutical industry with expertise in PK and clinical pharmacology.
• Strong background in drug metabolism and pharmacokinetics.

Responsibilities

• Develop and implement DMPK and clinical pharmacology strategies.
• Oversee clinical studies to characterize PK and PKPD properties.
• Interact with stakeholders and regulatory agencies.

Skills

Clinical Pharmacology

Drug Metabolism

Pharmacokinetics (PK)

Cross-functional Teamwork

Communication Skills

Education

Ph.D. / Pharm.D.

Job description

Senior Principal Scientist/Associate Director - Oncology PKS

Job ID REQ-10040605

Feb 25, 2025

USA

Summary

#LI-Hybrid

The position is located in Cambridge, MA or East Hanover, NJ and requires the ability to be on site for team meetings and department interactions.

We are seeking an enthusiastic and motivated PK Sciences project team representative to develop and implement DMPK and/or clinical pharmacology strategies to support the pursuit of transformative new medicines from early discovery through late clinical development. Our unique organizational structure enables colleagues to work seamlessly in the discovery and/or clinical space, offering opportunities for development and bench-to-bedside-to-bench translation.

Key Responsibilities:

1. Represent the PK Sciences function in project teams, interactions with stakeholders within the organization and interactions with regulatory agencies, as appropriate.
2. Develop the PK translational strategy and provide expertise to the design of First in Human studies, oversee execution of the clinical study to characterize PK and PKPD properties.
3. Work with teams to elucidate the understanding of PK/PD relationships and develop dosing strategies and predictions.
4. Develop and execute clinical pharmacology strategies, including input into nonclinical and clinical study design, and analyzing PK and PK/PD data, to support compound development from discovery through late development.
5. PK, dosimetry (radiopharmaceuticals), PK/PD and M&S component of study protocols, reports, project summaries and development plans, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections/radiation dosimetry of IND/IMPDs and NDA/BLAs as well as prepare appropriate responses to Health Authority questions across the globe.

This role reports to a PK Sciences (PKS) Oncology group lead/unit head within Translational Medicine (TM) in Biomedical Research. PK Sciences plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, bridging drug discovery and clinical application.

Minimum Requirements:

1. Ph.D. / Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related background.
2. A minimum of 10 years of experience in pharmaceutical industry or relevant environment (e.g. academia, biotech or CRO) in a field related to PK and/or clinical pharmacology.
3. A minimum of 10 plus years of experience required to be considered for Associate Director level including 5 plus years of experience in a lead role overseeing ADME/DMPK project strategy.
4. Extensive and in-depth knowledge of pharmacokinetics including, drug metabolism and PK/PD evaluation.
5. Demonstrated success in working in a cross-functional, matrixed, project-team environment.
6. Strong oral and written communication skills.

Preferred Requirements:

1. Experience with Radiopharmaceuticals.
2. Experience with translational or/and clinical development.

This is a dual level posting. The final level and title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered.