[Hiring] Senior Medical Director, Clinical Development @Syndax Pharmaceuticals

Role Description

The role will report to the Executive Medical Director in Clinical Development. The Senior Medical Director, Clinical Development is responsible for the creation and execution of clinical development plans within cross-functional project teams.

• Oversee several clinical stage assets and provide clinical input into business development opportunities as needed.
• Work closely with key internal and external stakeholders.
• Provide input into global regulatory strategy development.
• Participate in the preparation of submission documents and responses to regulatory agency queries.
• Be a strategic leader providing a strong, clear voice for the clinical program.

Key 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.
• Ensure robust clinical input into Target Product Profiles (TPPs).
• Provide robust clinical input into global regulatory strategy, and co-lead interactions with global Health Authorities (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 Senior 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 Investigator-Sponsored Trial (IST) strategy.

Qualifications

• 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 Clinical Development Plans (CDPs) with a cross-functional team.
• Strong ability to integrate biological knowledge into clinical development strategy.
• 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.
• Able to manage interactions with external CROs, consultants and other contract organizations.
• 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.
• Strong written and verbal communication skills.

Location

Syndax’s corporate office is in New York, NY.

Benefits

• Total compensation and rewards package that is among the most competitive in the industry.
• Base pay determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity.
• Overall package includes an equity offering, annual target bonuses, and an outstanding benefits program.
• The anticipated annualized salary range for this role is $375,000 - $398,000.

Company Description

Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include:

• A menin inhibitor for R/R acute leukemia.
• A monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease.

For more information, please visit www.syndax.com or follow the Company on X and LinkedIn.

Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.