ROLE DETAILS

We are looking for an experienced, skilled, and expert clinical supplies specialist to join the CMC team. In this role the Associate Director of Clinical supplies will work closely with CMC and Clinical functions to ensure the continuity of Mereo’s Clinical Studies. The expectation is that this person will further develop Mereo’s Clinical Supply systems and approaches whiles being an integral part of the various program teams focussed on delivering products needed for Mereo’s expanding clinical study activities, while leading the Mereo clinical supply activities.

 

 

Job Title:

Associate Director Clinical Supplies

Reports to:

SVP CMC and Manufacturing

Salary Range:

Competitive

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)

Closing Date:

31st March 2021

How to Apply:

CV and covering letter

 

 

Recruitment Contact:

jointheteam@mereobiopharma.com

Interview Date:

Week commencing ASAP

 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 in 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.

 CURRENT COMPANY SET-UP

All Mereo staff are currently due to Covid 19 restrictions entitled to work from home, however, the office remains open for those who need to be in the office for various activities or need to come in for their mental well-being. .  In normal circumstances, this role will be based in the Company’s HQ office in London and Mereo will continue to adhere to the UK Government’s guidelines regarding working practices under the current COVID pandemic situation, adapting our working practices accordingly. 

 

 THE POST

Purpose of the Associate Director Clinical Supplies role:

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

Main Responsibilities:

  • Lead all global clinical supply chain related activities for new and ongoing studies and any new product acquisitions, ensuring production schedule adherence and Good Manufacturing Practice (GMP) compliance.
  • Interprets complex clinical protocols/development plans and works with CMC and internal and external customers/suppliers to develop supply packaging and labelling strategies, timelines, and plans.
  • Negotiate, develop, and communicate clinical supply project budgets and plans and to ensure that all project objectives are captured and tracked.
  • Interfaces with CMC team to ensure adequate and suitable bulk IMP supply and that appropriate stability programs are in-progress, and/or appropriate expiry dating exists.
  • Maybe required to actively represent Mereo Clinical Supply and/or CMC team interests on partnered programs with a co-sponsor or external development partner.
  • Breadth of responsibilities may comprise demand forecasting, procurement, shipping and blinding of bulk drug. Scope may also encompass components such as test article, comparators, placebos, and ancillary supplies as applicable.
  • Consideration of end to end clinical supply planning process including timing of shelf life extension(s), bulk drug product manufacturing capacity, scenario planning and import/export considerations for product movement across the globe.
  • Accountable for CMO’s operational activities from request for proposal, day to day operations, troubleshooting, invoicing, and performance measures (KPIs, metrics) where established.
  • Oversight for the execution of product, packaging, labelling, distribution, resupply strategy, return, reconciliation, and destruction activities of IMP at multiple locations.
  • Interfaces regularly with appropriate Clinical, Regulatory, Quality and project teams to ensure ongoing compliance and troubleshooting.
  • Suitable IXRS selection, set-up, User Acceptance Testing (UAT) and execute ongoing operational aspects.
  • Ensures that CMO and supplier costs are accrued properly, that budget is reviewed periodically and managed appropriately, and that invoices are paid expeditiously. Ensures that activities are performed at contract vendors in accordance with expectations, regulations, and quality standards.
  • Fosters the preservation of valued contract providers relationships.
  • Works with Logistics to facilitate and troubleshoot movement of goods when required.
  • Coordinate timely Mereo batch disposition and Qualified Person/Quality Unit release of IMP in collaboration with both internal and external partner(s).
  • Interfaces with appropriate QA personnel to facilitate expeditious release of IMP and/or sites.
  • Supports appropriate IMP in use at the GMP/GCP interface. For example, developing training materials such as Pharmacy Manuals, ensuring appropriate storage requirements and managing temperature excursions, supporting IMP accountability and reconciliation.
  • Works to ensure creation and maintenance of Clinical Supply IMP documentation and product specification files (where required) according to established good practices.
  • Ensure study related key CMC documents are accurate and available in the electronic Trial Master File (e-TMF) as per Good Clinical Practices guidelines.
  • When required, will attend Product Development Team meetings and/or individual team meetings to facilitate bi-directional project level communication.
  • Will partner with other functions to successfully transition products from development to commercial stage and support efforts to establish and rationalize commercial stocks.
  • May also have personnel management responsibility.
  • When required, coaches personnel, develops performance objectives, and conducts periodic performance reviews. Identifies resourcing needs and develops justifications.
  • Will consider and implement opportunities to streamline, harmonize and create work efficiencies.
  • Maybe required to create and present to upper management.
  • Develops working precedents to ensure Mereo’s business needs are met over the longer term.

 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

  • BS/MS/Engineer/Pharmacist

Languages

  English

Knowledge & Experience

 

  • Minimum 15 years’ experience in Clinical Supplies management at a biotech or pharmaceutical development environment (CMO).
  • Demonstrated track record of successfully managing complex international clinical studies.
  • Broad understanding of regulatory and GMP requirements for IMP manufacturing and supply.
  • Solid understanding and experience in design specifications and UAT of IXRS applications.
  • Project management skills, tools, principles, and applications.
  • Expertise in outsourcing and supplier management.
  • Proficiency with clinical supply planning and forecasting tools.
  • Demonstrated experience in building-out an to end to end clinical product supply chain.

     

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.
  • Comfortable transcending all levels of the organization, customers and suppliers, to execute, strategize, manage, resolve and influence as needed.
  • 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.
  • 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.
  • An excellent bi-directional communicator, organized, and demonstrate effective team leadership.
  • 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.
  • 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 send your CV and covering letter.

The deadline for applications is: 31st March 2021

Please e-mail your application form to jointheteam@mereobiopharma.com with the job title included in the subject line.  You will receive a response to acknowledge receipt.

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

 SELECTION PROCESS & DATE OF INTERVIEWS

Stage one:

Please submit completed application forms via email to jointheteam@mereobiopharma.com

Stage two:

Short-listed applicants will be sent a letter inviting them to interviews which are scheduled to take place via Microsoft Teams as necessary.

 

Our Mission

Our mission is to provide new therapies to patients with life limiting oncology and rare diseases that have few, if any, other treatment options.

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