Senior Medical Director, Clinical Development

Syndax Pharmaceuticals•New York, NY

1d•$375,000 - $398,000•Remote

About The Position

Syndax Pharmaceuticals is seeking a Senior Medical Director, Clinical Development to provide strategic clinical leadership for its cancer therapy programs. Reporting to the Executive Medical Director in Clinical Development, this role creates and executes clinical development plans within cross-functional project teams and oversees several clinical-stage assets. The Senior Medical Director also provides clinical input into business development opportunities as needed and works with internal and external stakeholders on regulatory strategy, submissions, and responses to agency queries. The role leads clinical development across early- and late-phase trials, including protocol development, medical monitoring, safety assessment, interpretation and presentation of study results, and scientific writing and review of clinical and regulatory documents. It collaborates with Clinical Operations, Drug Safety, translational medicine, Medical Affairs, external opinion leaders, CROs, and other partners. Syndax’s corporate office is in New York, NY; the posting includes the hashtag “#LI-remote.” The anticipated annualized salary range is $375,000–$398,000. The overall compensation package also includes an equity offering, annual target bonuses, and a benefits program. Syndax is an equal opportunity employer.

Requirements

MD or MD/PhD.
At least 5–10 years of clinical research experience, preferably in an industry setting.
Clinical and clinical-trial experience in hematology.
Track record of building clinical development plans with cross-functional teams.
Strong ability to integrate biological knowledge into clinical development strategy.
Ability and willingness to work across a broad range of responsibilities, including interactions with senior internal leaders and the supervisory board, while retaining primary clinical responsibility for study-level work.
Ability to work independently and collaboratively in a fast-paced, results-oriented, dynamic environment.
Recognized internal medical leader with extensive technical expertise and effectiveness as a Clinical Lead in a multi-level matrix corporate environment.
Ability to interact with or direct clinical research project teams that include physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel.
Ability to manage interactions with external CROs, consultants, and other contract organizations.
In-depth knowledge of own function and scientific expertise to resolve critical issues successfully and innovatively.
Ability to evaluate key business and scientific challenges and complete complex, ambiguous initiatives with cross-functional impact.
Ability to work independently, prioritize multiple tasks and goals, and deliver programs on target and within budget.
Excellent interpersonal skills and ability to work effectively within a team.
Strong written and verbal communication skills.

Nice To Haves

Sub-specialty training or board certification in hematology, oncology, or a related field.

Responsibilities

Develop and implement clinical development plans and study protocols with a multidisciplinary Development Team.
Represent Clinical Development with senior internal and external stakeholders.
Provide clinical assessment and input for business development opportunities.
Ensure robust clinical input into target product profiles (TPPs).
Provide clinical input into global regulatory strategy and co-lead interactions with global health authorities.
Identify and select clinical investigators, maintaining appropriate communication and professional relationships as the Sponsor medical monitor or representative.
Oversee clinical trial programs with Clinical Operations in accordance with applicable SOPs, Good Clinical Practice, and regulations.
Provide medical-monitoring oversight for early- and late-phase trials in conjunction with the CRO.
Assess and disposition adverse events with the Drug Safety physician and evaluate compound safety before and during clinical studies.
Analyze, interpret, and present clinical study results to internal and external audiences as directed by senior management.
Assist with recruitment, training, and development of clinical teams.
Write and review clinical study reports and related regulatory documents.
Provide periodic status updates and communicate effectively with the Senior Management Team.
Collaborate with translational medicine on clinical biomarker strategies.
Work with Medical Affairs and external opinion leaders to secure collaborators, present trial results, and shape investigator-sponsored trial (IST) strategy.