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:

Vice President and Head of Pharmaceutical Development

Reports to:

Dr John Lewicki (who is based in the US)

Salary Range:

Competitive in industry

Duration of Post:

Full Time

Working Hours:

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

Location:

London Office (at least 3 days in office and optional up to 2 days working from home)

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 being investigated in a range of rare tumours and gynonc tumours ii) a neutrophil elastase inhibitor being investigated in the rare disease Alpha-1 Anti-trypsin Deficiency and iii) an anti-sclerostin antibody being developed for the rare disease osteogenesis imperfecta by our partner Ultragenyx Pharmaceuticals 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, where this role is based, 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.   There are currently six members of the management team based in the London office (including the CEO), three on the West Coast and two on the East coast.

CURRENT COMPANY SET-UP

This role will be based in the Company’s HQ office in London and Mereo will continue to adhere to the UK/US Government’s guidelines regarding working practices under the current COVID pandemic situation, adapting our working practices accordingly. 

As the UK has begun to reopen in line with the vaccination program, Mereo staff are currently attending the office on alternate days with social distancing and other measures in place (including rapid testing) due to Covid 19 restrictions. 

THE POST

Purpose of this role:

We are looking for an enthusiastic, skilled, experienced, and motivated professional to join the team. 

Main Responsibilities:

The Employee’s duties and responsibilities shall be as follows:

 

  • Overall responsibility and oversight for all CMC and associated activities relating to Mereo’s product portfolio of large and small molecules
  • Responsible for supervising CMC team members and annual resource planning
  • Responsibility for supervising and/or leading relationships with CMOs and other appropriate third parties
  • Ensure successful technology transfer from any of Mereo’s pharmaceutical partners to the selected third party CMO and ensure all the documentation is in place.  Where appropriate, this includes running or overseeing the process for selection of the CMO and negotiation of the documentation.
  • Also ensure successful outbound technology transfer where necessary if Mereo licenses/divests a product to a pharmaceutical marketing partner.
  • Work with the senior leadership clinical team to ensure strategies are executable from a manufacturing perspective, with an emphasis on meeting defined quality and compliance requirements.
  • Ensure efficient and successful scale-up of products, for both late-stage development and as appropriate post-approval production to support full commercialization.
  • Closely collaborate with Clinical Operations, CRO (currently ICON and Syneos) and QA.
  • Developing and oversee the CMC sections of regulatory filings.
  • Interact with regulatory bodies (FDA and EMA) as required, including attending meetings as appropriate regarding all CMC activities.
  • Identifying and working with external consultants and advisors as required including for regulatory strategy with FDA and EMA.
  • Participating in CMC due diligence for potential new product acquisitions

 

 THE PERSON

NOTE:  Applicants who have not clearly demonstrated on their CV that they possess the essential experience and knowledge will not be short-listed.
Desirable elements are those that is would be useful for the post-holder to possess and will be used to assist the short-listing process where we receive a large volume of highly qualified applications. The skills, capabilities and qualities section will be assessed during the interview process.

Essential

Desirable

Education, Qualifications & Training

Educated to Degree level or equivalent in a relevant discipline

  • PhD and/or relevant Master’s degree or equivalent (essential)

Languages

  English (Essential)

Knowledge & Experience

  • Minimum of 10 years prior experience in CMC at a pharmaceutical and/or biotech company
  • 12+-15 years
  • Leadership CMC experience in biologics or small molecule, but with some experience in both
  • Leadership CMC experience in biologics and small molecules
  • Leadership CMC experience with both early stage (post-IND) and late-stage products (pre-BLA/NDA)
  • Includes successful filing of BLA/NDA
  • Experience and a track record of success in working with CROs, including biologics CROs.
  • As essential, but experience with multiple CROs
  • Senior CMC leader at a well recognized pharma/biotech company
  •  Head of overall CMC at a major biotechnology/pharma company

Attributes

  • Excellent communication and influencing skills
  • Highly self motivated with ability to work under own initiative
  • Highly organized with ability to prioritize workload and meet challenging deadlines
  • Promotor of inclusion and collaboration and effective team leader
  • Ability to operate in rapidly changing, highly complex environments
  • Experienced in analyzing situations and data to formulate risk/benefit assessments and propose 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.
  • 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 send 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.