Director, Medical Affairs

Director, Medical Affairs

Clintec International

Glasgow, United Kingdom

THE ROLE

As the Director, Medical Affairs, you will deliver senior medical, clinical and scientific advisory expertise to the company.

You will act as a medical expert throughout business development activities by developing and leading the medical strategy.

You will oversee all aspects of medical involvement on proposed and/or assigned studies including support of pre-award/proposal activities and support to study teams and investigators of awarded studies. This will specifically comprise COVID-19 clinical trial designing and execution.

As an expert medical monitor, you will provide medical oversight as the first line of support for clinical trials to which you are assigned to.

You will lead the management of a team of Medical Monitors and drive the Medical Affairs department to support the company in achieving high performance deliverables.

MAIN RESPONSIBILITIES

Medical Operations:

  • Lead the Medical Affairs department agenda, ensuring resources are available to meet deliverables timelines and quality requirements and guaranteeing adherence to GCP principles;
  • Effectively line manage a team in planning, assigning and directing work; review Medical Monitoring Plans; appraise performance, mentor and guide professional development; address employee relations issues and resolve problems;
  • Represent the Company’s Medical Affairs department at Sponsor audits and Meetings with follow-up as necessary;
  • Provide Medical input into CAPA resolution.

Business Development Activities:

  • Collaborate with Feasibility and Business Development to actively solicit new business for the Company, including expert input into strategic discussions relating to proposal development and marketing/sales presentations;
  • Attend bid defences in an expert capacity representing the Medical Affairs department;
  • Attend conferences and/or meetings in support of business development opportunities.

Clinical Activities:

  • Review and provide medical input for protocol development and associated materials; interact with key sponsor stakeholders to develop inclusion/exclusion criteria and study endpoints; contribute to developing statistical and data management sections of the protocol; review the final protocol for clinical, safety and efficacy variables
  • Design and deliver trainings to project teams on therapeutic indication and/or treatment modality;
  • Drive the development and final review of criteria for investigator site selection and networking for potential investigators for study participation;
  • Actively participate in subject recruitment and retention activities, including calls to key opinion leaders, investigators and site staff, and actively contributes to teleconferences and virtual presentations;
  • Per sponsor request, present protocol and/or safety reporting information at investigator meetings;
  • Develop and implement project medical monitoring plan;
  • Provide first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues.

Safety Monitoring Data Review:

  • Lead the interactions with Safety Management Department for medical review and case assessment while interacting with sponsors and investigative sites to discuss safety issues;
  • Drive the regulatory interactions concerning safety and other study related issues;
  • Develop Medical data review strategies for studies which include eCRFs and edit check specifications, individual and aggregate data review, lab alerts, medical coding review;
  • Direct the team to implement data visualisation tools to enable medical review for efficacy and safety variables, concomitant medications, medical history, etc.
  • Lead the development of final clinical study report with results interpretation and discussion.

ESSENTIAL REQUIREMENTS

  • M.D, board certified/board eligible preferred;
  • Degree in Clinical Research and Biostatistics;
  • Proven extensive biopharmaceutical industry experience or academic experience in drug development and clinical research;
  • Previous experience in a similar role;
  • In depth working knowledge of ICH GCP;
  • Experience in COVID-19 Clinical Development programmes including but not limited to designing, execution, and providing medical oversight;
  • Strong working knowledge of Clinical Development including Statistics and Pharmacovigilance;
  • Strong, demonstrated experience in team leadership;
  • Outstanding ability to work independently with minimal supervision;
  • Ability to work effectively within a team and a matrix environment;
  • Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus;
  • Ability to organise and work efficiently on multiple projects, each with specific requirements and/or shifting priorities;
  • Strong communication and interpersonal skills, with the ability to establish and maintain relationships with internal and external stakeholders at various levels;
  • Excellent command of English (spoken, reading and writing);
  • Ability to travel domestically and internationally as required.

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EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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