I am currently partnered with a growing pharmaceutical company in New York City who is looking to add an exceptional Senior Medical Director, Clinical Development to their team! The Senior Director of Clinical Development is responsible for leading the clinical program for one or more product candidates within a specific therapeutic area (psychiatry or CNS/neurology). This role will act as the Clinical Program Lead for the assigned CNS product candidates including product planning and life cycle management.
JOB RESPONSIBILITIES
- Lead the creation of and provide scientific insight into study designs and disease area strategy
- Oversee or lead protocol development, Investigator's Brochures, annual regulatory reporting, and clinical study reports
- Work in close collaboration with regulatory and CMC to develop and execute program strategies from IND through all phases of clinical development
- Engage Key Opinion Leaders for innovation approaches to study design and drug development
- Develop timelines and integrated program plans for the tracking of product / project deliverables
- Champion and facilitate program team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders
- Partner with the Clinical Study Team to oversee the execution of clinical studies
- Provide scientific insight into study design and disease process
- Train clinical study team on therapeutic area, drug product, and protocol, as needed
- Oversee 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 findings
- Author, review, and revise Standard Operating Procedures (SOPs), as needed
- Lead/contribute to publication planning, authoring and presentation of abstracts, posters, slides, and manuscripts
- Contribute to pharmacovigilance monitoring AEs, SAEs, and FDA reporting and database reconciliation
- Participate in data review of clinical and safety measures at the patient level and in aggregate to assure subject safety and efficient study conduct
- Supervise or mentor other Clinical R & D team members
- Additional responsibilities as assigned
QUALIFICATIONS
- Post-graduate degree required, science-focused qualifications strongly preferred, e.g., MD., PharmD, PhD, with at least 10 years of clinical research experience
- Strong understanding of the drug development process up to and including clinical trial initiation and execution (IND submission through Ph 4 studies)
- Experience in preparing and submitting INDs and (s)NDA
- Strong 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 guidelines
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
- Excellent team player; willingness and ability to fill functional gaps in a small but growing organization
- Preference to energetic candidates with a desire to think "outside the box"
- Willingness to travel as needed, up to 20%
- Ability to work on site Monday, Tuesday and Thursday
