layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Senior Medical Director, Clinical Development at Syndax Pharmaceuticals

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.
Ensure robust clinical input into TPPs.
Provide robust clinical input into global regulatory strategy, and co-lead interactions with global HA.
Leads in the identification and selection of clinical investigators for clinical trials and maintain appropriate communication and professional relationships as Sponsor medical monitor/representative.
Oversee the clinical trial program in conjunction with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulations.
Provide medical monitoring oversight for early and late phase trials in conjunction with the CRO.
Conduct 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.
Analyze, interpret, and present results of clinical studies to internal and external audiences as directed by Sr. Management.
Assists in the recruitment, training and development of the clinical teams.
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.
Collaborate with translational medicine for the development of clinical biomarker strategies
Work with Medical Affairs and external opinion leaders to secure new collaborators, present trial results and shape IST strategy.
Desired Experience/Education and Personal Attributes: MD or MD/PhD with at least 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.
Clinical and clinical trial experience in Hematology.
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.
Location
: Syndax’s corporate office is in New York, NY.

Senior Medical Director, Clinical Development

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