Location: New York,NY, USA
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 Senior Director of Clinical Development for early stage studies. The incumbent is responsible for leading the clinical program for one or more product candidates within a specific therapeutic area (psychiatry or neurology) for early phase studies. This role will act as the Clinical Program Lead for the assigned product candidates including product planning and life cycle management. This role reports to the Executive Director, Clinical Development. This role is based at Axsome's HQ in New York City. Job Responsibilities and Duties include, but are not limited to, the following: Lead the creation of/provide scientific insight into study designsOversee or lead protocol development, Investigator's Brochures, annual regulatory reporting, and clinical study reportsWork in close collaboration with regulatory and CMC to develop and execute program strategies from IND through all phases of clinical developmentEngage Key Opinion Leaders as neededDevelop timelines and integrated program plans for the tracking of product / project deliverablesPartner with the Clinical Study Team to oversee the execution of clinical studiesProvide scientific insight into study design and disease processTrain clinical study team on protocol requirements as neededOversee or contribute to Clinical Study Reports (CSR), and clinical sections of INDs and NDAs (Module 5)Drive and present abstracts, poster presentations, slides, and manuscripts of clinical study findingsLead/contribute to publication planning, authoring and presentation of abstracts, posters, slides, and manuscriptsProvide input into clinical pharmacology strategyParticipate in data review of clinical and safety measures at the patient level and in aggregate to assure subject safety and efficient study conductSupervise or mentor other Clinical R & D team membersRequirements / Qualifications Post-graduate degree required, science-focused qualifications strongly preferred, e.g., MS., PharmD, PhD, with at least 8-12 years of clinical research experiencePrevious work in a CNS indication is preferredStrong understanding of the drug development process up to and including clinical trial initiation and execution (IND submission through Ph 2 studies, expertise in Clinical Pharmacology studies)Ability to work on site Monday, Tuesday & Thursday Experience and Knowledge Experience in preparing and submitting INDs and (s)NDAStrong analytical and problem-solving skills with excellent communication (both oral and written)Experience writing clinical documents (eg, protocols, CSRs, IBs,) and regulatory documents (eg, INDs, briefing books, NDAs)Thorough understanding of FDA, GCP and ICH guidelinesComfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing prioritiesExcellent team player; willingness and ability to fill functional gaps in a small but growing organizationPreference to energetic candidates with a desire to think outside the box Willingness to travel as needed, up to 20%Salary & BenefitsThe anticipated salary range for this role is $245,000 - $260,000. 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.