Contractor, DMPK and Bioanalysis

Syndax Pharmaceuticals; New York (NY); Remote; USD 80,000 - 150,000; Full time

Job summary

An established industry player is seeking a Contractor for DMPK and Bioanalysis, offering a unique opportunity to lead the development of large molecule drug candidates. This role involves overseeing nonclinical studies, collaborating with a skilled team, and contributing to regulatory submissions. Candidates with strong backgrounds in pharmacokinetics and drug metabolism will find this position rewarding. Join a forward-thinking company committed to advancing cancer therapies and making a significant impact in the field. If you are passionate about improving patient outcomes and ready to take on a leadership role in DMPK, this is the perfect opportunity for you.

Qualifications

• 8+ years of industry experience in DMPK and bioanalysis.
• Strong knowledge of pharmacokinetics and ADME concepts.

Responsibilities

• Design and execute preclinical studies for drug candidates.
• Author high-quality regulatory documents including INDs and NDAs.

Skills

Drug Metabolism

Pharmacokinetics

Bioanalytical Principles

ADME Concepts

LC/MS/MS Method Development

WinNonlin Software

PK/PD Experience

Communication Skills

Interpersonal Skills

Leadership Experience

Education

BS/MS in relevant field

PhD/PharmD

Tools

WinNonlin

Job description

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Syndax Pharmaceuticals is looking for a Contractor, DMPK and Bioanalysis

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role:

Syndax is seeking a motivated individual with accountability for overseeing all aspects of DMPK relating to the development of large molecule drug candidates, including the design, conduct, and reporting of nonclinical DMPK studies as well as bioanalysis of nonclinical and clinical studies data. Reporting directly to the senior director, head of clinical pharmacology, you will have the opportunity to collaborate with a highly skilled team and make a significant impact on our scientific endeavors. This is an exciting opportunity to be the DMPK and bioanalytical lead for a potential NDA.

Key Responsibilities:

1. Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of drug candidates.
2. Represent DMPK and bioanalysis as the subject matter expert at project teams.
3. Responsible for the analysis, interpretation, integration and reporting of preclinical DMPK data generated with external vendors/academic sites.
4. Directs the planning of all relevant nonclinical (DMPK), bioanalysis and PK/PD analyses. Utilizes consultants, CROs to accomplish work.
5. Coordinates with medical writers (and other team members) in the data review, analysis, and reporting of the nonclinical DMPK studies.
6. Author high quality Regulatory documents including INDs, CTAs and NDA filings. Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management and other departments.
7. Participate in the preparation of abstracts and manuscripts for publication.
8. Accountable for ensuring that there are valid methods for measuring drug concentration (and any biochemical biomarkers) in the clinic.
9. May participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management.

Desired Experience/Education and Personal Attributes:

1. BS/MS and >8+ years of industry experience or PhD/PharmD with >3 years of industry experience.
2. Strong knowledge of drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles is required.
3. Experience using WinNonlin or other pharmacokinetic software is a plus.
4. Experience with PK/PD.
5. Experience with LC/MS/MS method development is desirable.
6. Excellent written and verbal communication skills.
7. Demonstrated presentation skills.
8. Excellent interpersonal skills and ability to represent DMPK in a team environment are essential.
9. Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, oversee, and guide the work of external colleagues (consultants and CROs) to achieve meaningful outcomes and create business impact.

Location

While our corporate headquarters are located in New York City, this position is open to candidates from any location with a preference for east coast locations.

About Syndax:

Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include Revuforj (revumenib), an FDA-approved menin inhibitor, and Niktimvo (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X (formerly Twitter) and LinkedIn.

Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.