Associate Director, Commercial Counsel

Syndax Pharmaceuticals is looking for an Associate Director, Commercial Counsel

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 Commercial Counsel role is a unique opportunity to join a small experienced legal team and help support Syndax as a commercial stage organization with two newly approved products and the potential for future launches of additional indications. Commercial Counsel will be responsible for providing strategic legal advice and guidance to Sales, Marketing, Market Access, Medical Affairs, Regulatory Affairs and other business partners. He/she will be involved in all aspects of the commercial business and operate as part of a team focused on supporting the commercialization of two oncology assets. The attorney provides counsel concerning a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales strategies, and interactions with healthcare professionals.

Key Responsibilities:

• As a key member of the commercial team, proactively counsel and partner with team on commercial strategy, brand objectives and business operations of Syndax products, providing legal support across the full life cycle of assets.
• Provide strategic legal advice to the business to ensure compliance with applicable U.S. laws and company policies, including federal and state antikickback and false claim laws, the deferral Food Drug and Cosmetic Act (FDCA) laws, regulations and additional FDA guidance’s, the PhRMA code, state laws, antitrust laws, and federal and state transparency laws.
• Serve on cross-functional commercial teams including without limitation, promotional review committee, scientific review committee and other review committees requiring asset legal representation.
• Review business materials (including brand plans, promotions, medical plans, training documents) requiring legal input and advising internal clients, partners and stakeholders on compliant strategies, plans and tactics.
• Analyze business initiatives for antitrust, privacy, fraud and abuse, FDA and other regulatory compliance.
• Work collaboratively with Compliance colleagues to ensure operations comply with applicable law and company policies and on policy interpretation and training.
• Partner with legal department colleagues in executing and enhancing Company objectives.

Desired Experience/Education and Personal Attributes: 

• Juris Doctorate (J.D.) degree from a nationally recognized law school and an active license to practice law.
• 5+ years of experience in the biotech/pharmaceutical industry, preferably with at least 2 years of in-house experience.
• Experience with the launch of branded drugs and/or new indications.
• Experience with FDA laws and regulations, in particular, promotional and nonpromotional review, and guidance provided by the Office of the Inspector General for HHS is required.
• Excellent oral and written communication skills; strong presentation skills, with the ability to communicate abstract ideas and legal advice to executive and senior management as well as non-legal colleagues and non-native English speakers.
• Excellent critical thinking skills. Ability to work through complex issues, including those with significant strategic risk to the company.
• Ability to anticipate and proactively identify legal issues that could affect Syndax as a whole and advise clients on how to resolve these issues.
• Strategic, analytical thinker and creative problem solver who possesses innovation, client management, demand management skills and regulatory knowledge.
• Demonstrated broad understanding of the business environment and capable of anticipating future challenges resulting from change and the ability to adapt quickly and keep up with a fast‐paced and highly demanding environment and regulatory framework.
• Familiarity with the federal Anti-Kickback Statute, False Claims Act and U.S. privacy laws.
• Some travel will be required for this role.

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  $230,000 - $250,000.

About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include Revuforj® (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. 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 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.

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