Clinical Development Sciences, Medical Director

Position Summary

The Medical Director 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 physician(s) and the

therapeutic area head with deliverables necessary for effective and efficient clinical

development plan design and execution and therapeutic area strategy. Responsible for the

design and execution of 1 Ph3 or 2-3 smaller studies and for ensuring subject safety and is the

co-leader of the clinical study team (with clin ops). May supervise or provide medical oversight

for other associates.

Principal Responsibilities

• 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 (may manage several studies in parallel).

• Lead a study team to design a clinical protocol, including engaging with relevant
  
  
  

internal and external stakeholders; responsible for preparing materials and protocol

defense presentation for C-PRC review. Represent the clinical study team at the

clinical subteam.

• May supervise and develop Medical Directors and CDS in preparation of clinical
  
  
  

study related documents including protocols, charters, statistical summary reports,

meeting presentations, publications, and clinical sections of regulatory documents

P a g e 2 o f 4

• Participate in Investigator meeting planning and execution and/or on-site initiation
  
  
  

meetings

• Lead 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.

• Lead 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. Serve as the Medical Expert for clinical

study team.

• Liaise with other functions to design external expert consultations, contribute to the
  
  
  

development of study concepts and designs, protocols and study essential

documents. Engage with clinical investigators nonclinical studies to enable quality

clinical execution, analyze and interpret clinical data, and collaborate with the

broader team to define clinical and therapeutic area strategy. Engage with

investigators, site staff, CROs, and site monitors to maintain enthusiasm and support

enrollment for ongoing clinical studies. Where appropriate, serve as the SME for

identification, translation, inclusion, implementation and reporting related to liquid,

tissutal and/or imaging endpoints.

• Lead the execution of clinical trials and associated data collection activities,
  
  
  

providing guidance to the clinical study team related to:

• country and site feasibility assessments and selection
• site training and oversight
• patient recruitment
• ongoing data monitoring
• study closeout
• Maintain 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

• Help to determine appropriate advisory boards experts
  
  
  

P a g e 3 o f 4

• Provide support for business development activities, such as due diligence and research
  
  
  

collaborations

• May serve as the Translational Science lead for one or more programs
  
  
  

Qualifications

• MD or equivant
• History of industry or academic clinical or basic science research
• Excellent written / oral communication skills
• Ability to think strategically
• Willingness to take on new responsibilities
• Attention to detail
• Interest in career progression and ability to take on a more senior role in 1-3 years
  
  
  

Education

• Required: M.D. or equivalent
• Preferred: Advanced knowledge of the assigned therapy area is desired, with the
  
  
  

capability to interpret, discuss and represent trial or program level data.

• 2+ years of industry experience in clinical development is preferred
  
  
  

Competencies

• Previous clinical trial experience as medical monitor in industry setting (Safety medical
  
  
  

monitoring and reporting experience; Protocol development experience; Understanding

of regulatory requirements related to clinical trials & Basic statistical knowledge)

• Subspecialty certification
• Board Certification
• Business development experience
• 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
  
  
  

P a g e 4 o f 4

• For those assigned to clinical endpoint support, e.g., imaging, experience in at least one
  
  
  

meaningful modality, e.g., ultrasound, computerized tomography, magnetic resonance,

positron emission tomography

• Specific therapeutic area experience
• 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