JOB-RELATED INFORMATION

This document includes information about the role for which you are applying and the information you will need to provide together with your CV and covering letter.

ROLE DETAILS

Job Title:

Director, Clinical Development

Reports to:

Suba Krishnan

Salary Range:

Competitive in industry

Duration of Post:

Full Time

Working Hours:

40 hours per week, with some occasional out-of-office hours according to company needs

Location:

US

Recruitment Contact:

jointheteam@mereobiopharma.com

 THE COMPANY

Mereo is an international, clinical-phase biotech company with a focus on rare diseases and oncology.  Our vision and mission are to bring safe and effective first-in-class treatments to areas of high unmet medical need.  Founded in 2015, we currently have 3 development programmes, in oncology and rare diseases.  These are : i) an anti-TIGIT antibody program in solid tumors, with a focus on rare cancers and gynecological malignancies ii) a neutrophil elastase inhibitor being investigated in the rare disease Alpha-1 Anti-trypsin Deficiency and iii) A neutrophil elastase inhibitor in AATD and other rare disorders. We aspire to harness the energy, drive, commitment and focus of a small company to build value into all our programmes and to work closely with all stakeholders in order to accomplish this. 

Our headquarters are located at Cavendish Place, London, UK, and we have colleagues based on the East and West Coast in the US.

More information is available on our website at:  www.mereobiopharma.com.

 CURRENT COMPANY SET-UP

All Mereo staff entitled to work from home (due to Covid 19 restrictions). 

In normal circumstances, this role will be based Princeton, New Jersey, USA, but Mereo will continue to adhere to the US Government’s guidelines regarding working practices under the current COVID pandemic situation, adapting our working practices accordingly. 

 THE POST

Purpose of the role:

Join an exciting, fast-paced scientifically-driven, clinical-stage oncology and rare disease company with multiple corporate partnerships and robust plans to expand the product portfolio.  The role will be focussed on our TIGIT oncology program. TIGIT is currently the most clinically advanced target in the immunooncology landscape and is garnering lots of attention! Reporting directly to the SVP, Clinical Development, you will support the high-profile lead study within Mereo’s TIGIT clinical development program in a new role that combines clinical operations and clinical science. 

You will be responsible for providing clinical operations leadership in the planning, implementation, and direction of clinical operations-related activities in support of corporate objectives. Responsibilities also include oversight of clinical study conduct and execution of departmental and corporate objectives, study level finances/budget oversight, partner vendor management, inspection readiness, adherence to project timelines, and compliance with study protocol design and GCP/ICH standards. Beyond that, this role provides a unique opportunity to gain experience in assembling, interpreting, and presenting scientific and medical data with direct mentorship to grow in this capacity. For the right candidate, this is a rare and unique opportunity to gain broad oncology drug development experience and grow with an exciting biotech company with highly experienced leadership passionate about bringing new therapies to patients with life limiting oncology and rare diseases with few treatment options.

Main Responsibilities:

 

  • Provide leadership with regards to the overall tactical planning and successful implementation of the lead study within the TIGIT clinical development program. 
  • Lead Clinical Operations function in study team activities and meetings (including cross-functional internal and external) that involve execution of department and corporate objectives within study timelines and budgets
  • Responsible for the planning, implementation and conduct of the lead clinical trial within the TIGIT program while ensuring compliance with FDA regulations, GCP/ICH, and applicable company SOPs
  • Ensure that all assigned clinical study operations activities are conducted efficiently, meet enrollment goals, and are in compliance with all applicable regulations and company policies and procedures.
  • Accountable for the internal and external work product for clinical operations, data management, biostatistics, regulatory and pharmacovigilance to ensure program milestones are met.
  • Participate in the evaluation, selection and management of CROs, contractors, and vendors as well as vendor oversight in monitoring of all aspects of clinical trial conduct including study start-up activities (CRO/vendor management and oversight, contract CTLs/CRAs and other consulting staff, etc.)
  • Develop and manages essential project plans, through establishment of tracking and reporting appropriate performance metrics. Utilize metrics to manage continual improvement of the project.
  • Oversee the data collection activities for all assigned clinical programs.
  • Oversee the implementation of the clinical development plan by managing the site contracts, budget, timelines, CRO resources, enrollment, and site activities.
  • Provide input on CRF design and ensure quality data is monitored and available to support annual reports, investigator brochures, regulatory filings, and safety summaries.
  • Develop and maintain effective working relationships with internal team and external partners.
  • Identify issues that may impact the overall project plans and initiate contingency plans, as appropriate.
  • Develops strong and productive working relationships with key stakeholders throughout the global organization, drive tactical strategy for clinops related to the lead clinical trial and effectively express his/her views to senior management.
  • Provide positive, professional leadership as the Clinical Operations.
  • Working with the lead physician on the program, monitor and evaluate emerging clinical data, performing periodic review of clinical data and provide support for data analysis of study medical data.
  • Participate in planning for interim data analyses and reviews, including Independent Data Monitoring Committee (IDMC) meetings.
  • Review/interpret data to help produce relevant abstracts, presentations and manuscripts.
  • Work with medical writer and other relevant team members to prepare clinical documents including but not limited to: clinical protocols, briefing documents, IND annual reports, Investigator's Brochures, clinical protocols and amendments, clinical study reports, scientific manuscripts and abstracts, posters and scientific presentations.

 

 THE PERSON

Education, Qualifications & Training

 

  • Ability to develop collaborative working relationships with vendors, site staff, site physicians, expert consultants, and contracted vendors.
  • Strong analytical mind, excellent written/verbal communication skills, attention to detail, organizational skills, and ability to work independently and as part of a team.
  • Strong document management skills, including proficiency with MS Word, EndNote, Excel, and Powerpoint.
  • Knowledge and experience in clinical operations and clinical development
  • Ability to multitask to meet timelines under changing conditions.

 

Languages

  English

Knowledge & Experience

Educated to Degree level or equivalent in a relevant discipline

  • At least 5-7 years of experience in the pharmaceutical industry.
  • Experience in oncology indications is preferred, experience in immuno-oncology is a plus.

Skills, Capabilities & Qualities 

 

  • Excellent organisational and time-management skills, with ability to prioritise workload and meet deadlines with high-quality deliverables in a busy and rapidly changing environment.
  • Excellent communications abilities.
  • Highly self-motivated and hard-working with the ability to work well under own initiative.
  • Good relationship-builder, able to foster good working relationships inside and outside the organisation.
  • Nimble in a highly dynamic and agile organization where changing priorities are the norm.
  • Intuitive with well-honed interpersonal communication skills; listens and challenges when appropriate.
  • Effective with global workgroup associates, sharing information in a timely fashion, freely and sensitively.
  • A promotor of inclusion and collaboration to achieve evolving team goals.
  • Tenacious and persistent with counterparts to explore evolving clinical study needs.
  • At times willing to operate at the micro level or beyond defined boundaries when required.
  • Able to handle multiple projects and conflicting priorities, simultaneously while maintaining high quality results.
  • Capable of providing and implementing innovative solutions to unique and pressing situations.
  • Able to recognize potential conflicts and hurdles and escalate when necessary.
  • An excellent bi-directional communicator, organized, and demonstrate effective team leadership.
  • Able to work with abstract global problems of substantial scope and complexity using regulatory guidelines, industry accepted positions, technology trends, SOPs, leadership skills and experience to analyze situations and data to formulate risk assessments and agreed upon course(s) of action.
  • Aware and compliant to FDA, EMA, PMDA regulations and requirements for functioning under GMP, GCP’s, Annex 13, and EU CT Directive.
  • Able to demonstrate a fundamental knowledge of drug development process.
  • Knowledgeable and technically proficient in industry standard technology and/or available software, processes and industry trends to streamline and or improve efficiencies.
  • Understanding of the positioning of, and work in compliance to, SOP’s, Change Controls, Deviations, Investigations and CAPA’s.

Excellent IT skills, including Microsoft Office Suite (Word, PowerPoint, Excel, Outlook, etc.)

Must be IT competent and have a knowledge of data protection.

 THE APPLICATION PROCESS & WHERE TO SEND COMPLETED APPLICATIONS

Please e-mail your CV and covering letter to jointheteam@mereobiopharma.com with the job title included in the subject line. 

If you do not hear from us within 2 weeks of application, you should assume that your application has been unsuccessful on this occasion.