Chief Medical Officer - Scotland

Clinical Operations - Medics & Medical Affairs
Ref: 941 Date Posted: Friday 12 Jan 2018
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Our client are a disruptive, pioneering, Oncology based Biotech, who have recently gone through vast investment, resulting in team expansion to support business growth internationally. They are a reputable company with patient experience being at the core of the brands ethos, with this role at the forefront of Clinical Development encompassing full oversight of the candidate pipeline.

 

The Chief Medical Officer will have overall responsibility for implementing and expanding the company clinical development operations globally, with a particular emphasis on the US and EU.   The position will include building and managing relationships with KOLs and Investigators and raising brand profile in the broader clinical community. The CMO will also be responsible for leading the clinical development team and have responsibility for overseeing all clinical activities including clinical and regulatory strategy, clinical development programs, clinical operations, biostatistics, data management, and drug safety. This position will include responsibility for the successful execution of clinical research programs from Phase I through registration for a pipeline of programs in oncology. The position will be responsible for developing new anti-cancer medicines in the US, EU and globally, reporting directly into the CEO.

 

 

 

Principal Responsibilities:

 

 

The Chief Medical Officer will have responsibility for building and leading the entire clinical organization, including the following:

 

  • Responsible for the selection and delivery of optimal clinical studies to generate data that will differentiate our product candidates from the current standards of care.  Some of our ongoing and planned studies are designed to generate pivotal data for NDA / MAA submissions. 

 

  • Responsible for budget, staffing, program management and schedules to ensure timely completion of clinical milestones.

 

  • Responsible for establishing relationships and interactions with contract clinical research organizations as required.

 

  • Responsible for interfacing with the Board of Directors on a regular basis to discuss and interpret clinical results and strategy.

 

  • Responsible for serving as an integral member of the leadership team in evaluating new product / therapeutic opportunities through internal development and/or business development initiatives.

 

  • Responsible for providing the leadership on all clinical research matters and functions including strategic development, Phase I-IV study design and execution, data analysis and integrated regulatory documentation. 

 

  • Responsible for overseeing internal clinical teams and external CROs on the implementation of multiple clinical programs with a focus on meeting program timelines and managing resources efficiently. 

 

  • Responsible for interfacing with the FDA, EMA and other global regulatory agencies with responsibilities for preparing all appropriate regulatory documents including INDs/CTAs;  NDAs/MAAs and DSURs.

 

  • Responsible for initiating and maintaining relationships with key opinion leaders, investigators and the broader clinical community in the U.S. and Europe. This includes close collaboration with the teams conducting Investigator Sponsored Studies.

 

  • Responsible for participating as an executive team member in the interfacing with investors and potential partners.

 

 

 

 

Candidate Qualifications:

 

The successful candidate will possess:

 

  • An M.D. and have relevant medical training in the field of oncology/haematology with significant experience and expertise in the field of clinical drug development.

 

  • A successful track record leading the clinical development of oncology drug candidates Phase I through III in US and EU.

 

  • Experience in developing drugs for the following tumour types is a strong plus: ovarian, colorectal, pancreatic, biliary, breast and haematological malignancies.

 

  • A sound understanding of clinical development issues as well as practical aspects of implementation of development programs in a hands on actively engaged manner.  Ownership and accountability for the various programmes is a necessity.

 

  • Experience and understanding of data management, screening of patients for recruitment and overall experience overseeing clinical operations function.

 

  • An expertise in all aspects of resourcing clinical development activities including managing budgets, hiring, developing and mentoring personnel and managing external relationships including CROs, co-operative groups, partners and regulatory authorities.

 

  • Must be a leader and a manager with the knowledge and experience to “get things done” in a highly entrepreneurial environment.

 

  • Ability to set high/but reachable goals, clearly communicate these goals and infuse the team with a sense of purpose and urgency in attainment of these goals.

 

  • Organized, effective leader with the ability to define priorities and focus on areas that add value to the business.

 

  • Highly effective in developing processes necessary to achieve results including organizing individuals and activities.

 

  • Excellent analytical and strategic planning skills with a track record of delivering on high-performing clinical studies.

 

  • Excellent judgment and decision making skills, ethics.

 

  • Ability to motivate and influence various parts of the organization regardless of level.

 

  • A demonstrated ability to effectively manage change and comfortably change direction and act without complete information.

 

  • Ability to work in an early stage, high growth start up environment with the ability to wear many hats and have a ‘hands-on’ approach to tasks and actions.

 

  • A track record of building successful collaborations with key opinion leaders/investigators, pharmaceutical and biotech organizations as well as relationships with the FDA/EMA.

 

  • Exceptional verbal and written communication skills. 

 

  • A willingness to travel globally.