Discover Impactful Work:

This position provides strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process. This person is responsible for the design, development and execution of Clinical Development Plans (CDPs), clinical trials and protocols in accordance with applicable GCP regulations. This person leads and contributes to the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical/regulatory objectives and the documentation of study results.
This person may act as a clinical/medical representative in meetings with external stakeholders (e.g. collaborators, Key Opinion Leaders (KOLs), investigators, regulatory authorities, etc.), partners (e.g. vendors, consultants, etc.) and other external audiences as needed.

A day in the Life:

Provides medical content and leadership of the clinical studies
Medical Monitoring of clinical studies
Establish and approve scientific methods underlying the design and implementation of clinical protocols
Ensure study subject safety
Regularly review adverse event, laboratory and other clinical data, ensure reporting is done on a timely basis
Collaborate with the study executive and independent safety committee when needed
Represent clinical research through membership on trial teams.
Contributes to, reviews and approves study protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents as required for the conduct of clinical trials
Interprets, summarizes and documents clinical data for regulatory documents (e.g. INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required.
Collaborate with leading academic medical centers
Recruit, guide and motivate clinical investigators
Ensure study compliance by understanding and applying all relevant SOPs and GCPs
Participate in long range strategic planning

Education

MD degree with specialization in Psychiatry/ Neurology is mandatory
Drug Development experience in the area of Psychiatry/ Neurology
Desirable: Experience in the therapy areas of (Monoclonal Antibodies) and/or Translational Medicine.

Knowledge, Skills, Abilities

Demonstration and commitment to vigilant proactive problem solving
Excellent leadership abilities
Able to provide multiple examples of creating and implementing the scientific and clinical principles used for the preparation of clinical studies and clinical trial protocols.
Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data.
Previous experience with regulatory submissions.
Excellent written and verbal communication skills.
Ability to travel.