Responsibilities

• Lead design and implementation of one or more clinical development programs and provide strategic and operational guidance to teams, based on medical and scientific expertise and sound clinical judgment.
• Lead development of clinical sections of study/program level documents (e.g., clinical synopsis, protocols and amendments, Investigator’s Brochures, safety updates, submission dossiers, and responses to Health Authorities).
• Medical support to the clinical study team and have an overall responsibility of medical oversight/monitoring for clinical studies.
• Ensure the safety of the subjects in the clinical trials through appropriate medical monitoring of studies on a proactive and ongoing basis.
• Perform medical and safety assessments following the review and analysis of Serious Adverse Events, adverse event reports and specified safety inquires and investigations in collaboration with Pharmacovigilance.
• Evaluate pharmacology, safety and efficacy data from ongoing and completed studies.
• Interface with clinicians/investigative sites for protocol-related issues, including protocol clarifications, inclusion/exclusion determinations, and issues of subject safety and/or eligibility.
• Conduct literature reviews and prepare summaries to support clinical development programs.
• Provide medical leadership and scientific guidance to CROs.
• Be a medical resource for design and interpretation of clinical and preclinical programs to support existing and new development pipelines.
• Providing medical expertise to support business development activities and conduct due diligence for assessing scientific, medical and development feasibility.
• Interact with key opinion leaders related to assigned compounds and therapeutic area; contribute to NDA and EMA filings and prepare relevant sections of the regulatory documents; serves as a clinical representative for communications with regulatory agencies.

Qualifications

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree or Pharm D.
• At least 3-5 years of experience in clinical development and medical monitoring.
• Clinical practice including post-graduate direct patient care experience preferred; board certification or equivalent, neurology or psychiatry preferred.
• Clinical trial design and management experience; experience of agency communications preferred.
• Ability and desire to work in a team-oriented environment and work effectively with cross functional teams.
• Excellent verbal, writing, presentation, and editing skills.
• Excellent communication, interpersonal skills to interact with the internal leadership team, external partners and investigators/medical professionals.
• Ability to proactively look into issues and solve problems.
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams.
• Strong knowledge of FDA, EMA, PMDA and other regulatory requirements, GCP/ICH.

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