Senior Medical Director, Clinical Development

Syndax Pharmaceuticals; United States; Remote; USD 375.000 - 398.000; Vollzeit

Zusammenfassung

Syndax Pharmaceuticals is looking for a Senior Medical Director, Clinical Development to lead and execute clinical development plans for multiple assets. You will collaborate with cross-functional teams, influence regulatory strategy, and provide medical leadership across the program.

The role reports to the Executive Medical Director in Clinical Development and requires a strong track record in hematology/oncology with industry experience.

Qualifikationen

• MD or MD/PhD with 5–10 years in clinical research, preferably in industry.
• 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.

Aufgaben

• Develops and executes clinical development plans and study protocols with a multidisciplinary team.
• Represents clinical development with senior internal and external stakeholders.
• Provides input for business development opportunities and regulatory strategy.
• Contributes to global regulatory strategy and co-leads interactions with global health authorities.
• Leads investigator identification and maintains sponsor medical monitoring relationships.

Kenntnisse

Medical leadership

Communication

Cross-functional collaboration

Clinical development strategy

Regulatory strategy

Ausbildung

MD or MD/PhD

Board cert in hematology/oncology

Jobbeschreibung

Syndax Pharmaceuticals is looking for a Senior Medical Director, Clinical Development

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role:

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 (clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory, drug safety). The role will oversee several clinical stage assets and provide clinical input into business development opportunities as needed. They will work closely with key internal and external stakeholders, provide input into global 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 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.

Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also 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.

About Syndax:

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 and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visitwww.syndax.com/or follow the Company onXandLinkedIn.

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