Join our growing team of individuals dedicated to collaboration, life-long learning and seeing a day in which people with cancer live markedly longer and better lives. Syndax Pharmaceuticals, Inc. offers a competitive salary and benefits package. Qualified candidates should submit their resume and cover letter with a statement of interest, availability, and experience in Word or PDF format to: careers@syndax.com. Syndax is an Equal Opportunity Employer. Note to Recruiters – Thank you for your interest in Syndax and our recruitment opportunities. Recruiting and employment are managed through the Human Resources Department. Syndax requires that a signed agreement be in place prior to the presentation of any candidates. We ask that recruiters and agencies do not contact or solicit employees or managers in an attempt to present candidates. The company will not be obligated or responsible for any related fees to resumes that are unsolicited.

  • Associate Director / Director, Biologics Drug Substance

    Position Description:
    At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. We are a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. We have an opening for a biologics drug substance Associate Director/Director. The scope of the role encompasses mid to late-stage antibody development and manufacturing activities including process characterization, validation, and regulatory submission writing.

    The candidate will oversee the planning and execution of outsourced antibody drug substance development and manufacturing. They will define project scope in conjunction with CMO/CROs, ensure appropriate quality and regulatory requirements are met, and ensure that timelines and budgets are on track.

    Responsibilities

    • Define and manage drug substance CMO activities. Build strong relationships with all CMO/CROs involved in the program.
    • Review Master and Executed Batch Records, release testing data and stability data.
    • Provide direct oversight and represent Syndax CMC as person-in-plant during certain critical manufacturing activities at participating CMO/CRO sites.
    • Participate in designing comparability and characterization studies and review reports.
    • Perform risk assessment for upstream and downstream activities; create and implement any remediation plans necessary.
    • Apply a science and risk-based approach for addressing deviations, investigations, and process issues.
    • Provide clear communication to functional group and project teams.

     
    Requirements

    • Ph.D. and 10 years of biopharmaceutical manufacturing experience or MS with more than 10 years of relevant experience.
    • Experienced in all aspects of antibody drug substance manufacturing and development including expression, upstream cell culture operations, downstream purification operations, process and analytical characterization, and process validation.
    • Experienced in advancing processes through clinical development to commercialization.
    • Demonstrated ability to work outside of the box and influence novel CMC and regulatory pathways to accelerate development.
    • Knowledgeable and practiced with Single Use Bioreactors for GMP manufacturing.
    • Excellent written and verbal communication.
    • Demonstrated ability to work well in a fast-paced environment.
    • Must be able to effectively manage multiple activities and problem-solve to achieve business needs.
    • Strong communication skills, able to work independently and collaborate with key internal and external stakeholders.
    • Excellent planning and project management skills.
    • Dynamic and energetic, hands on approach to challenges.
    • Business travel to various CMO/CRO sites, company offices, suppliers, and partners as required.
  • Clinical Pharmacologist

    Syndax is seeking a motivated individual with accountability for overseeing all aspects of clinical pharmacology relating to the development of small 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. This is an exciting opportunity to be the clinical pharmacology lead for a potential NDA. Note that the title/level will be based on the candidate’s experience.

    Key Responsibilities:

    • Act as the Clinical Pharmacology representative on teams.
    • 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.
    • 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:

    • BS/MS and > 8 years of industry experience or PhD/PharmD with >5 years of industry experience.
    • Education in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, or other applicable fields of study.
    • Strong quantitative skills and expertise (e.g. experience in PKPD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations using NONMEM, R, 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 has offices in Waltham, MA and New York City and has a dispersed workforce across the United States. This role may be fully remote and travel to the Syndax offices for key meetings.

  • Senior Director, Human Resources

    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 clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

    The Role:
    The Senior Director, Human Resources is a key leadership role with responsibilities initially for talent acquisition and talent management. This role has an opportunity to grow and expand in partnership with a seasoned HR leader. The individual will have an opportunity to shape strategy and identify best practices aligned with the Syndax culture. The title will be based on the candidate’s experience.

    Key Responsibilities:

    • Drive Syndax talent acquisition strategy and ensure alignment with corporate strategies
    • Be viewed as the “talent guru” to the executive leadership
    • Partner with leadership to translate business strategies into bold talent strategies
    • Own the growth plan and results
    • Develop the employment brand and differentiate Syndax in the market
    • Provide organization leadership on talent management strategies
    • Ensure that all Syndax employees have opportunities to grow, learn and contribute
    • Collaborate across the organization to reinforce the culture

     
    Desired Experience/Education and Personal Attributes:

    • 10+ years in an HR or recruiting role with 5 years operating in talent acquisition at a life science company
    • Understands the competitive market for talent in life sciences
    • Has operated in an organization with strong talent management practices
    • Strong desire to innovate and identify solutions that fit with the Syndax culture
    • Willing to roll up sleeves and get work done
    • Deeply values diversity, equity, and inclusive environments
    • Experienced user of applicant tracking systems
    • Comfortable working with sensitive information and has unflappable ethics
    • Thinks deeply, seeks out and brings in best practices

     
    Location: Syndax has offices in Waltham, MA and New York City and has a dispersed workforce across the United States. This role can be fully remote and travel, as needed.