Associate Director, Medical Writing (Clinical Development)

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 highly collaborative Medical Writer to draft, edit and submit high quality, medically accurate documents including protocols and clinical study reports. This is a key position within the Clinical Development Group with ample opportunity to make real impact. The medical writer reports to the Head of 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:

• Interprets, analyzes, and synthesizes complex clinical data and develops high-quality strategic scientific documents including protocols, amendments, agency briefing books, clinical study reports, and other documents in support of Clinical Development programs   
• Attends strategic meetings as applicable
• Closely collaborates with, and apply applies strategic direction from, project leads, and biostatisticians in order to manage and prioritize assignments and ensure deliverables are completed per time and quality goals
• Previous experience with preparation and QC of clinical regulatory documents: Protocols, IBs, CSRs, Module 2 Summary Documents, Clinical Overviews and Agency Briefing Documents
• Develops documents for assigned programs in compliance with company standard operating procedures (SOPs)
• Participate in developing timelines, managing review/approval workflows, and QC/publication readiness
• Leads cross-functional teams to ensure team-wide agreement on documents content
• Oversees outsourced medical writings projects and the associated vendor(s), as applicable
• Drives Results
• Ensures compliance and accountability for all regulatory documents prepared by the company.

Requirements / Qualifications

• Advanced scientific or clinical degree (MD, PhD, or PharmD) required and a minimum of 6 years relevant experience
• A strong working knowledge of pharmaceutical drug development and GxP principles is required
• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

Experience and Knowledge:

• Highly knowledgeable in psychiatric and/or neurological disease areas is a plus
• Track record of developing high-quality scientific documents
• Ability to interpret, analyze, and synthesize complex clinical data into compelling and easily understood documents
• Familiarity with the preparation of Statistical Analysis Plans and document data mapping
• Experience with programmed outputs of tables, figures and listings for analysis and communication of clinical data
• Ability to work collaboratively with and coordinate the efforts of team members to resolve comments and complete deliverables
• Excellent interpersonal skills and judgement that facilitates working with cross-functional executive leadership, and maintaining the security of proprietary information
• Ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment
• Flexibility for adapting to rapidly changing deadlines and priorities
• Detail oriented
• Able to self-manage effort to maintain alignment with strategy and corporate goals

 Salary and Benefits:

The anticipated salary range for this role is $170,000 - $185,000. 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,