Sr Dir/ED Clinical Development, Revumenib
| Company/Institution: |
Syndax Pharmaceuticals |
| Location: |
Waltham, MA, US, MA, USA |
| Degree Requirements: |
MD, PhD |
Salary: |
$300,000 or above |
| Job Type: |
Other |
Posted: |
November 12, 2024 |
| Job Setting: |
Corporate (Biotech or Pharmaceutical) |
Application Period: |
November 12-December 12, 2024 |
Syndax Pharmaceuticals is looking for a Sr Dir/ED Clinical Development, Revumenib
The Role:
The role will report to the President, of R&D. The Sr Director/Executive Director, Clinical Development, Revumenib is responsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies within cross-functional project teams (clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory, drug safety) in particular for revumenib. The Sr Director/Executive Director, Clinical Development will be accountable for the development and implementation of the clinical development strategies/plans for the novel drug candidate and future indications. They will serve as the point of contact for investigators. He/she will also participate in 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.
Key Responsibilities:
- Develops and implements study protocols in conjunction with a multidisciplinary development
- Assist in the identification and selection of clinical investigators for clinical trials and maintain appropriate communication and professional relationships as Sponsor medical monitor/representative
- 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
- Oversee the clinical trials program in conjunction with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulations
- Analyze, interpret, and present results of clinical studies to internal and external audiences as directed by Sr. Management
- Identify resource requirements, assist in budget planning and personnel forecasting for clinical research programs
- Assists in the recruitment, training and development of the clinical teams.
- Identify and select clinical consultants
- Provide or assist in 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
- Leads the development of clinical biomarker strategies for clinical development
- Work with Medical Affairs and external opinion leaders to secure new collaborators and present trial results
- Interface with Research, Product Development and Business Development to assess new product opportunities, and develop clinical research strategy and product development plans
- Other duties as assigned.
Desired Experience/Education and Personal Attributes:
- MD or MD/PhD with at least 7 years’ experience in clinical research in either academic or industry setting
- Sub-specialty training or board certification in hematology, oncology, or related field
- 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 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
About the Employer
About Syndax:
Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include revumenib a highly selective menin inhibitor, and Niktimvo™ (axatilimab-csfr), a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment for both revumenib and Niktimvo. For more information, please visit www.syndax.com/ or follow the Company on X (formerly Twitter) 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.
How to Apply
To apply send a CV to Isabella Clemens (iclemens@syndax.com) with contact information.
Contact Information
Isabella Clemens
35 Gatehouse Drive
ste D-3
Waltham, MA 02451 USA
https://syndax.com/
iclemens@syndax.com
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