Medical Director Consultant

The Medical Director, Clinical Development may lead a cross functional team in the design and execution of a clinical study and may provide input into the global clinical development plans and strategy for a therapeutic area. The job holder supports assigned clinical development team and the therapeutic area head with deliverables necessary for effective and efficient clinical development plan design and execution and therapeutic area strategy.

You will be responsible for:

[Definition: Job Duties and Responsibilities]

Leading a team in preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents (may manage several studies in parallel).

May supervise and develop clinical development scientists and/or fellows; Lead a team in preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents

Participating in Investigator meeting planning and execution and/or on-site initiation meetings

Leading the execution of clinical trials; Monitor, clean, analyze and review safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.

Leading a team in study execution, including country and site selection, site training and start-up and data monitoring; expertise in data analysis and presentation required. Depending upon specific expertise in translational science, may lead a translational sub team of the clinical team.

Leading the execution of clinical trials and associated data collection activities, providing guidance to the clinical study team related to:

o country and site feasibility assessments and selection

o site training and oversight

o patient recruitment

o ongoing data monitoring

o study closeout

Maintaining awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy

You will need to have:

The minimum skills and requirements needed to proficiently execute the core responsibilities of the role.

Understanding of general (and specific) therapeutic principles

Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation

Familiar with scientific literature searches and weighing of quality peer reviewed data

Ability to clearly communicate to internal and external stakeholders orally and in writing

Specific therapeutic area experience; Experience in running clinical trials in neurology indications and/ or Rare Disease indications

Basics of strategic vs. tactical thinking

Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.

Strong business acumen; including in-depth knowledge of the multidisciplinary functions involved in a company s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results

The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

[You must also include the relevant Physical and Mental Requirements section for your position from the options provided in the Reference Guide]

We would prefer for you to have:

[Definition: Preferred Qualifications. The nice to have skills and requirements for the position]

Advanced medical degree (MD or MD equivalent required)

Residency training completion highly preferred. Prior experience in Neurology preferred, sub-specialty certification will be a plus.

Preferred: Advanced knowledge of the assigned therapy area is desired

5+ years of industry experience in clinical development is preferred

Prior experience with Regulatory Authority interactions will be very helpful

Prior experience with BLA or sBLA filing will be considered favorably