Senior Director, Clinical Pharmacology

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.   

About This Role:  

Axsome Therapeutics is seeking a dedicated and experienced Senior Director, Clinical Pharmacology to join our team. The ideal candidate will have a strong background in pharmacokinetics, pharmacodynamics, and early-phase clinical trial design. This role involves collaborating with cross-functional teams to support the development and implementation of clinical pharmacology strategies for new and existing drugs. The Senior Director, Clinical Pharmacology will report to the Vice President, Clinical Development.  

This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.  

Job Responsibilities and Duties include, but are not limited to, the following: 

• Design and oversee clinical pharmacology studies, including first-in-human, drug-drug interaction, and special population studies 
• Develop appropriate population PK models and PK/PD analysis required from a development and regulatory perspective  
• Develop and implement clinical pharmacology plans in collaboration with study teams 
• Prepare and review clinical study protocols, reports, and regulatory submission documents 
• Provide scientific and strategic input to clinical development programs 
• Collaborate with cross-functional colleagues, including biostatisticians, clinical scientists, and regulatory affairs to ensure the successful execution of clinical trials 
• Stay current with advancements in clinical pharmacology and regulatory requirements 
• Identify and manage consultant and vendors, as needed, supporting clinical pharmacology  

Requirements / Qualifications 

• 10+ years of experience in clinical pharmacology within the pharmaceutical or biotechnology industry 
• Ph.D. or Pharm.D. in Clinical Pharmacology, Pharmacokinetics, or a related field 
• Strong understanding of pharmacokinetics, pharmacodynamics, and clinical trial design 
• Experience with regulatory submissions and interacting with health authorities 
• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote positions.

Experience, Knowledge, and Skills 

• Experience with modeling and simulation software (e.g., NONMEM, WinNonlin) 
• Familiarity with Good Clinical Practice (GCP) guidelines and regulatory requirements 
• Proven track record of scientific publications and presentations 
• Excellent analytical, problem-solving, and communication skills 
• Ability to work effectively in a team-oriented environment 

Salary & Benefits 

The anticipated salary range for this role is $245,000 - $275,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. 

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.  

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.