Executive Medical Director, Clinical Development

Syndax Pharmaceuticals•New York, NY

3d•Remote

About The Position

Syndax Pharmaceuticals is seeking an Executive Medical Director, Clinical Development to join their team. This role reports to the Global Head of Development and is responsible for creating and executing clinical development plans within cross-functional project teams. The position will oversee preclinical and clinical stage assets, provide clinical input into business development opportunities, and collaborate with internal and external stakeholders. The Executive Medical Director will be a strategic leader, providing a strong voice for the clinical program and contributing to global regulatory strategy development and submission documents.

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.

Nice To Haves

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.
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.
Represents 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.