Syndax Pharmaceuticals is looking for a Senior Director, Clinical Pharmacology

 

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 clinical pharmacology relating to the development of small and large molecule drug candidates, including the design, conduct, and reporting of clinical pharmacology studies and incorporation of model-based drug development to ensure innovative clinical strategy.  This individual will be responsible for establishing and maintaining strong relationships with colleagues from clinical and nonclinical disciplines, to ensure program goals are achieved. 

 

 

Key Responsibilities: 

Formulate a comprehensive clinical pharmacology strategy and an associated clinical development plan that aligns with the target product profile and overarching program objectives. Serve as the primary Clinical Pharmacology Lead and effectively participate in cross functional teams to insure integration of clinical pharmacology principles into project plans and study design. Responsible for providing the clinical pharmacology components of Clinical Plans and providing clinical pharmacology expertise to study and project teams including planning, designing and overseeing clinical pharmacology studies with assistance from clinical operations colleagues. Management oversight of junior members of the department which may include both DMPK and bioanalytical functions. Fully knowledgeable about the clinical pharmacology profiles of drugs on which studies are being conducted, or which are called for in the protocol. Coordinates with medical writers (and other team members) in the data review, analysis and reporting of the clinical pharmacology studies. Responsible, in conjunction with medical writer, for overall content and accuracy of study report. Accountable and responsible for non-compartmental analysis of PK data and accountable and - as appropriate - responsible for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, meta-analysis etc. Directs the planning of all relevant PK-PD analyses. Utilizes consultants, CROs to accomplish work. Responsible for use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with pharmacometrics and statistics (as relevant). Ensures alignment on recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing, etc.) to the clinical teams and in regulatory documentation. Leads clinical pharmacology contributions to all regulatory documents including IND, CTA, Investigator Brochures, EOP2 meetings, NDA. Leads the resolution of clinical pharmacology queries from regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries. During the pre-clinical stages of drug development, works with Discovery to ensure quantitative mechanistic understanding and preclinical PK-PD knowledge exist to underwrite human administration. Accountable for ensuring that there are valid methods for measuring drug concentration (and any biochemical biomarkers) in the clinic. May participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management.

  

 

Desired Experience/Education and Personal Attributes: 

MS and more than 18 years of industry experience or PhD/PharmD with more than 15 years of industry experience. Education in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, or other applicable fields of study. Strong quantitative skills and expertise (these should include experience in PKPD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations using NONMEM, R, phoenix NLME etc.). Comprehensive understanding of clinical regulatory requirements and knowledgeable in ICH and GCP guidelines. Excellent written and verbal communication skills. Demonstrated presentation skills. 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: Syndax’s corporate office is in New York City.

Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $260,000 - $290,000. 

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.

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