Executive Director, Clinical Development

Syndax Pharmaceuticals•New York, NY

3h•Remote

About The Position

Syndax Pharmaceuticals is looking for an Executive Director, Clinical Development. 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 will report to the Global Head of Development. The ED Clinical Development is responsible for the creation and execution of clinical development plans within cross-functional project teams (clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory, drug safety). The role will oversee several preclinical and clinical stage assets, with the potential to build a team as the assets evolve and provide clinical input into business development opportunities as needed. They will work closely with key internal and external stakeholders, provide input into global regulatory strategy development and participate in the preparation of submission documents and responses to regulatory agency queries. They will be a strategic leader providing a strong, clear voice for the clinical program.

Requirements

MD or MD/PhD with 5-10 years’ experience in clinical research preferentially in an industry setting.
Sub-specialty training or board certification in hematology, oncology, or related field preferred.
Experience in early development and with designing first in human studies is a plus.
Track record of building CDPs with a cross functional team.
Strong ability to integrate biological knowledge into clinical development strategy.
Strong ability and willingness to work across a broad dynamic range, including interactions with senior internal leaders / supervisory board, while maintaining primary clinical responsibility for study level work.
A creative problem solver with the proven ability to work independently and collaboratively in a fast-paced, results-oriented and dynamic environment.
Recognized as an internal medical leader with extensive technical expertise and demonstrate effectiveness as Clinical Lead on a program, operating in a multi-level matrix corporate environment, requiring interaction with, and/or direction of clinical research project teams, including physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel.
Able to manage interactions with external CROs, consultants and other contract organizations, especially from the context of a small group.
Applies in-depth knowledge of own function and scientific expertise to solve critical issues successfully and innovatively.
Ability to evaluate key business / scientific challenges and complete complex, ambiguous initiatives that have cross-functional impact.
Able to work independently and prioritize multiple tasks and goals to ensure programs are delivered on-target and within-budget.
Excellent interpersonal skills and a demonstrated ability to work well within team structure is essential; Strong written and verbal communication skills.
Experience with working in an alliance would be a plus.

Responsibilities

Develops and implements clinical development plans, as well as study protocols in conjunction with a multidisciplinary Development Team.
Represent clinical development with senior internal and external stakeholders.
Provides input and clinical assessment for business development opportunities.
Ensures robust clinical input into TPPs.
Provides robust clinical input into global regulatory strategy, and co-leads interactions with global HA.
Supports the identification and selection of clinical investigators for clinical trials and maintains appropriate communication and professional relationships as Sponsor medical monitor/representative.
Conducts medical assessment and disposition of adverse events (in conjunction with Drug Safety physician) and evaluate safety of clinical compounds prior to and during ongoing clinical studies.
Oversees the clinical trials program in conjunction with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulations.
Analyzes, interprets, and presents results of clinical studies to internal and external audiences as directed by Sr. Management.
Identifies resource requirements, assists in budget planning and personnel forecasting for clinical research programs.
Assists in the recruitment, training and development of the clinical teams.
Identifies and selects clinical consultants as needed.
Responsible for the scientific writing and review of clinical study reports and related regulatory documents.
Provides periodic status updates and effectively communicates with the Senior Management Team.
Collaborates with translational medicine for the development of clinical biomarker strategies.
Works with Medical Affairs and external opinion leaders to secure new collaborators, presents trial results and shapes IST strategy.
Other duties as assigned.