Job Summary - a concise overview of the job
The primary responsibility of the Medical Monitor (MM) is the accountability for the strategic planning and execution (including study design, method selection, etc.) of Phase I through IV global clinical trials. In addition to conducting medical review and interpretation of efficacy and safety data from clinical studies, the MM also oversees the ongoing medical monitoring of clinical studies and is advisory council for safety issues/concerns that arise or protocol deviations/violations.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Endo Pharmaceuticals Clinical Development
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
· Drive the clinical development strategy for one or more indications, including successful regulatory submission.
· Design and optimize Clinical trial design.
· Oversee and is responsible for the quality, coordination and timeliness of protocol development and protocol amendments.
· Analyze and interpret data (ex. Lab values, adverse events etc) expertly, and clearly communicate results both internally and externally; present and discuss data and findings at relevant team, DSMC, governance, KOL and regulatory meetings.
· Work collaboratively with the clinical study team/CMO and other team members to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (CSRs, IBs, IND sections, CTAs, ISS and ISE sections and clinical expert reports).
· Work collaboratively with the Pharmacovigilance team in reviewing SAEs and/or Pregnancy reports across all studies,
· Write narratives for AEs/SAEs/AESIs, as found required for studies,
· Assist senior management to oversee quality, coordination and timeliness of clinical sections of INDs,
· Participate, as required, as a clinical representative on Project Teams.
· Establish and maintain working relationships with Study Investigators, key opinion leaders, academicians, and Sponsor company senior managers and department heads.
· Ensure adherence to GCP/ICH and SOP standards related to medical concerns.
· Partner with US and EU regulators during inspections and responses.
· Mentor junior team members and provide guidance and opportunity for their professional development.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
· Minimum of a MBBS/M.D required.
· 4+ years in Clinical Medicine with at least 2 in the pharmaceutical industry.
Proven Experience in the following:
· Designing innovative clinical trial strategies to obtain regulatory approval.
· Leading strategic planning for an indication or disease state.
· Clinical project planning working on global and complex clinical trials.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
· Excellent understanding of drug development process.
· Thorough knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
· Maintain clinical and scientific awareness in area of expertise.
· Have the ability to anticipate and resolve problems; escalate as necessary, per prescribed process.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
· Ability to use scientific and clinical knowledge to conceptualize study designs.
· Work with, and develop, key opinion/thought leaders.
· Lead by example by promoting open communication and fostering teamwork demonstrate adaptability in a team/matrix environment.
· Excellent interpersonal skills and ability to communicate effectively with people in different regions and functions.
· Possess efficient leadership/project management skills and a focus on delivery of results with a sense of urgency and initiative.
· Organizational, scientific/technical writing and verbal communication skills.
· Have the ability to present clearly in scientific and clinical settings.
· Have the ability to lead cross-functional teams and be a true team player.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
· Sit / stand in an office environment.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.