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Current Assignments


Below is a selection of interim assignments that Interea is currently working on. Please note that the list is not exhaustive, and is intended primarily to demonstrate the wide range of roles with which we are asked to help.

If you have an interest in any of the assignments listed below, please contact Interea as soon as possible.

Interim Senior Regulatory Project Manager

Our client, based in the UK, is a well funded, small, rapidly growing and ambitious speciality pharma company currently at a very exciting stage in its life.  The company already has one product commercialised and has a promising pipeline of other products in Pre-Clinical, and Phases I, II and III.

The need has emerged for a talented, motivated and experienced Senior Regulatory Project Manager to join the company in what is a critically important role.  

This is an Interim role, likely to be (initially) of 3-6 months duration and demand 3-4 days / week.   The majority of the work will be conducted from a home base, although travel to London for occasional meetings will be necessary.

Reporting directly to the company’s Head of Regulatory Affairs, key areas of responsibility are as follows:

  • Support the Head of Regulatory in devising and developing the Company’s regulatory strategies for all development projects, manufacturing improvements, and the continued registration and licensing for all established products when applicable, including lifecycle management.
  • Act as a point of contact for all regulatory interactions with relevant agencies, including, but not limited to, application for and maintenance of clinical trial/investigational new drug applications, preparing all pre- and post- meeting strategies, and responses and life cycle management.
  • Support the Company at regulatory meetings with the Food and Drug Administration, European Medicines Agency, and other global regulatory agencies as required.
  • Preparation of registration dossiers and submission of Marketing Authorisation Applications (MAAs) / New Drug Applications in line with regulatory authority requirements; and interaction with all licensing partners, and designated vendors such as Contract Research Organisations and others where applicable, to facilitate the submissions of MAA’s in their territories
  • Support the Company in the preparation of all product information (including artwork), and provide advice and support in conjunction with the Head of Regulatory to ensure all manufacturer / importer and wholesale dealer licenses are maintained, as well as regulatory compliance with all change controls and Standard Operating Procedure (SOP) activities.
  • Work closely with the Company’s Head of Quality, and Director of Chemistry, Manufacturing and Controls, to ensure that clinical and manufacturing activities are conducted in accordance with Good Clinical Practice, Good Manufacturing Practice, and the associated local statutory requirements.
  • Support the Head of Regulatory in the design and planning of the development programs, both for the Company’s lead products and also for the Company’s product pipeline, to ensure they meet appropriate regulatory requirements and standards.

This is an excellent opportunity in an outstanding company of real potential.  If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible.  Phone 01844 – 202989 or email to gn@interea.co.uk

 

 

 

Head of Biometrics : Interim (or Permanent)

Our Client is a highly ambitious and full service international Contract Research Organisation (CRO) with capabilities in both early stage and late stage clinical development.

The company is headquartered in the UK, but has operations across Europe, Australia and the United States, together with capabilities in multiple other territories.

Given the rapidly growing size and complexity of the business, the need has emerged for an experienced professional to take on the role of Head of Biometrics.  This role has overall responsibility for both Data Management and Statistics (c. 40 people in total), and reports directly to the company’s Chief Operating Officer.

This is a newly created position and is understandably one of critical importance within the company. 

Our Client’s objective is ultimately to find someone to take on the role on a permanent basis, but given that it may take some time to identify and appoint the right person, the decision has been made to appoint an Interim Head of Biometrics for an initial period of six months.

Given the situation, there is clearly a genuine possibility of a subsequent interim to permanent transition should both parties so wish.

This is a senior level role and candidates must have a significant level of Data Management / Statistics experience, with a proven track record of success in either a CRO or a well-respected pharma / biotech company.   A proven ability to manage people is a must-have.

This is an excellent opportunity in an ambitious and growing company.  The contribution to be made will be highly visible and of critical importance.  For candidates interested in the permanent position, the opportunities for further career development are certainly there.

If this opportunity is a good fit with your own areas of experience and expertise, please make contact with Geoff Newman (Interea) as soon as possible.



CFO (Permanent)

A critically important (permanent) need has arisen in one of Interea’s very good clients – a UK-based pharmaceutical CMO that is highly ambitious and who recently raised a significant amount of money in order to build anew facility. 

This is transforming the company from one that less than 2 years ago employed c. 20 people to one that will soon be employing more than 120.

This will allow them to manufacture not just early clinical drug supply, but quantities sufficient for all stages of development as well as commercial quantities.

The need has arisen for an experienced CFO who can point to a successful career that encompasses:-

  • Senior finance role(s) in a PE financed SME
  • Proven ability to work closely with investors
  • Experience of the life sciences sector
  • Experience of acquisition / exit transactions
  • Proven ability to contribute significantly at Board level

This is a Board level position – an excellent opportunity in an exciting company.

If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible. Phone 01844 – 202989 or email to gn@interea.co.uk

Interim (Permanent) Head of Supply Chain

Our client is a UK-based highly successful company whose business is the design, development, manufacture, distribution and support of a number of class-leading automated instruments and their associated consumable in the bioscience and pharmaceutical research market.

Significant growth of the business has resulted in the need for a Interim Head of Supply Chain, with the assignment likely to be of not less than 6 months duration, 5 days / week.

Extension of the assignment is a genuine possibility, as is a transition to a position of full-time employment for the right candidate

This is a senior level role of critical importance and carries with it a broad range of responsibilities:-

  • Line management of function team heads (Planning, Purchasing, Order Execution, Supplier Quality Engineer etc.)
  • Delivering supply chain capacity to sales forecast and lead time targets.
  • Customer order receipt, acknowledgement and communication (internal and external).
  • Developing and negotiating supplier commercial agreements and capacity.
  • Supplier quality performance
  • Goods-in and goods-out functions.
  • Inventory and warehouse management.
  • Production and materials demand planning
  • Predicting and delivering internal capacity requirements.
  • Delivering best practice processes
  • Calculation of supply chain PI’s and KPI’s
  • Delivering continuous improvement.

Candidates must have significant experience in a senior Supply Chain Management role within a manufacturing/engineering environment.

As part of the operations team the Head of Supply Chain will work closely with senior management colleagues to deliver the best possible overall site performance. Knowledge of neighbouring business processes, good networking / communication skills and the ability to prioritise, influence and motivate are essential.

This is an excellent opportunity in a company of outstanding potential.

If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible.  Phone 01844 – 202989 or email to gn@interea.co.uk

Head of Medical Affairs (Permanent)

Our Client is an ambitious drug development company headquartered in North America, publicly quoted with a headcount of c. 200 employees.   European operations are centered in Switzerland.

The company has two marketed products approved in Europe (and other territories), both of which are in the cardiovascular area.  Other non-CV products are however in development as is a drug/device combination product for which regulatory submissions are planned over the coming months.

The need has emerged for a top-quality Head of Medical Affairs who will be responsible for collaborating across all European regions and functions to develop and then execute the Medical Affairs strategy, including Phase IV clinical trials and publications.  Responsibility will also encompass management of Pharmacovigilance.

This is a senior level role within the company and reports directly to the North-American based CEO.   The successful candidate will ideally be based in Switzerland, although outstanding candidates based within easy access of Geneva and who would be willing to undertake frequent visits there, will be considered.  A strong international (European) outlook / experience is important

It is likely that the successful candidate will possess the following areas of experience and expertise:-

  • Results-oriented and possess a proven track record of success in building and leading best-in-class medical affairs organisations within a growing world-class biopharmaceutical or medical device company.
  • Intense commitment to high moral standards and business ethics. Honesty, openness, and transparency are valued. Ability to build relationships that foster a cohesive, committed team environment across multiple locations and geographies. Ability to inspire others and bring out their best performance.
  • Medical degree or PhD.
  • A minimum of 10+ years total related work experience. At least seven years of pharmaceutical industry experience in medical affairs or other relevant discipline. Profound expertise in the field of cardiovascular disease.
  • A minimum of five years senior leadership experience; credible as a ‘thought leader’ and able to inspire others, creating a dynamic environment that fosters innovation in thought and execution, as well as transparency; able to work collaboratively across all levels of the organization and lead influentially, must have exceptional judgment, integrity, and ethics.
  • Ability to interact in a positive manner and effectively influence all constituencies, including management, scientists, board members, corporate partners and investors
  • Strategic Thinker/Change Agent: High-energy, accountable and forward-looking; able to see larger business picture. Persuasive individual with the ability to work at all levels to educate and gain buy-in for all programs and initiatives; track record of creating a positive imprint on an evolving business; able to engage in strategic business discussion and communicate the value of quality programs and initiatives and the value of change.
  • Effective Trusted Communicator: Able to effectively educate and influence other stakeholders.
  • Spoken and written fluency in English and eventually other European languages

 

This is an excellent and exciting opportunity in an ambitious and fast-growing company. The contribution to be made will be highly visible and of critical importance.

If this opportunity is a good fit with your own areas of experience and expertise, please make contact with Geoff Newman (Interea) as soon as possible.

Corporate Legal / Company Secretarial

A senior level and important need has arisen in one of Interea’s very good clients – a UK-based pharmaceutical CMO that is highly ambitious and who recently raised a significant amount of money in order to build anew facility.

This is transforming the company from one that 12 months ago employed c. 30 people to one that will employ over 100 by the end of Q1 next year.  This will allow them to manufacture not just early clinical drug supply, but quantities sufficient for all stages of development as well as commercial quantities.

Such expansion brings many changes, including their decision to appoint an in-house Corporate Legal professional rather than relying totally on external partners.

The need is for a high calibre individual with experience of the life sciences sector. Such experience will encompass overall legal counsel matters as well as investor agreements, articles as well as Board and company secretarial duties.

This opportunity is initially likely to demand c. 4 days / month including Board Meetings. This should not be considered an interim role, but the start of a longer-term relationship.

Ideally, the successful candidate should be in a position to start with our Client as soon as possible.

This is an excellent opportunity in an exciting company.

If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible. Phone 01844 – 202989 or email to gn@interea.co.uk

Medical Director : Interim / Permanent

Our client, based in the UK, is a small, AIM listed and ambitious speciality pharma company currently at a very exciting stage in its life.

Commercialisation of its first product in Europe has recently taken place, and its exciting product development pipeline comprises a number of products spanning Phases I, II and III here in Europe as well as in the US.

The need has emerged for a talented, motivated and experienced Medical Director to join the company in what is a critically important and senior role.

Reporting directly to the company’s CEO, the successful candidate will oversee and manage all clinical operations and regulatory development activities relating to all of its development programmes.  Specifically, a number of Phase 3 programmes for 2 products in Europe and the US, a separate product programme in the UK and a range of early stage pipeline programmes into the clinic.

The Medical Director will assume overall responsibility for the compliant execution of all clinical programmes in line with Good Clinical Practice (GCP) and in accordance with the statutory requirements of the European and US regions in which the studies are being conducted.

The successful candidate will:-

  • Be medically qualified
  • Have an impressive track record of pharmaceutical clinical development across all phases
  • Derive enjoyment from, and have experience of working with what are currently termed speciality medicines
  • Quite possibly have big pharma experience, but will need to have a proven track record of being able to deliver when working in small companies
  • Have experience of working successfully with the key global regulatory authorities, cf. European and US
  • Be able to contribute significantly, alongside other senior colleagues, to the development and implementation of the overall company strategy
  • Be able to work remotely
  • Be an excellent communicator, both internally and to a range of important and external third parties.
  • Be able to represent the company at all times with professionalism and integrity. The Medical Director will be seen as one of the key external faces of the company.
  • Have line management experience

Ideally, the successful candidate will probably start work with the company in September or early Q4– either in an interim capacity (3-5 days /week) or in an immediate position of employment.  If interim, the hope is that the successful candidate would be receptive to the idea of a possible subsequent transition to a position of full-time employment.

This is an excellent opportunity in an outstanding company of real potential.

If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible.  Phone 01844 – 202989 or email to gn@interea.co.uk

Interim Regulatory Affairs Director : EMEA

Our Client is an ambitious speciality pharma company, publicly quoted and with revenues in excess of $1 billion.  Global headquarters are in the US, with European operations managed via a base in the UK.

The company currently has a portfolio of pioneering and innovative products that are available in over 40 countries around the world and which help treat patients for a condition that is recognised as one of growing public health concern.

Other key products are in development and are expected to contribute significantly to the company’s future global growth in the coming years.

The need has emerged for an Interim Regulatory Affairs Director : EMEA who will be responsible for leading all regulatory affairs activities across Europe / EU and Middle-East Africa.

This is a senior level role, reporting directly to the Senior VP Global Regulatory Affairs in the US.

Key responsibilities include:-

  • Leading a team of regulatory professionals across Europe
  • Liaising directly with EMEA Regulatory Authorities
  • Defining global regulatory strategies and submissions in support of new and existing marketing authorizations.
  • Regulatory compliance

This interim assignment is expected initially to be of 6-12 months duration, probably demanding 4-5 days per week.  The successful candidate will be based in the European HQ in Greater London / Thames Valley, although it is likely that some work some work can be conducted from a home base. A modest amount of international travel will be required.

For the right candidate, the possibility exists for a subsequent transition into a permanent position of employment.

It is likely that the successful candidate will have…

  • Advanced degree in Pharmacy/Medicine/Pharmacology/Chemistry/Biology or other science-related field.
  • Master Degree in Regulatory Affairs a plus.
  • Minimum of 15 years of experience in the pharmaceutical regulatory field
  • Minimum of 4 years experience in a senior Regulatory position at European level
  • Minimum of 4 years experience in Regulatory Affairs Director position within a EU5 country
  • Previous people management experience across countries is required
  • Working knowledge of Regulatory Affairs regulations and major European health authorities. Knowledge of Middle-East regulations is a plus.
  • Experience of working in a specialty care category/disease space e.g.,psychiatry, mental health, stigmatizing diseases (HIV-HCV, alcohol addiction) is essential. Experience in controlled substance regulations is a plus.

This is an outstanding and exciting opportunity in an ambitious and fast-growing company.  The contribution to be made will be highly visible and of critical importance.

If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible.  Phone 01844 – 202989 or email to gn@interea.co.uk

Interim Head of Supply Chain

Our client is a privately-held, venture backed business that has genuine expertise in encapsulation technology that enables valuable active products to be protected, delivered and released where and when required.

Such technology has the potential to be of real interest to a wide range of industry sectors including pharmaceuticals, detergents, agrochemicals, cosmetics, fragrances etc.

The need has emerged for a interim Head of Supply Chain for an assignment of 3-6 months duration, probably averaging 10 days / month.  Extension of the assignment is a genuine possibility.

Key deliverables as follows:-

  • Implementation of S&OP software (vendor has just been selected)
  • Support of talented analytical chemist in assumption of role of QA lead
  • Identification of 2ndsource of manufacture in EU (Brexit) most probably Ireland
  • Set up identified contract manufacturers for finished packing of 2 products
  • Implementation of smooth supply chain for launch of a product through an on-line retailer in Sept.

This is an excellent opportunity in a company of outstanding potential.

If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible.  Phone 01844 – 202989 or email to gn@www.interea.co.uk

Comercial Lawyer : Biotech

Our Client is an ambitious and fast-growing specialist Process technology / Contract Manufacturing Organisation (CMO) highly active on the business development front in the US as well as Europe and Japan.

The need has emerged for an experienced biotech commercial lawyer to advise them on contract development and manufacturing agreements with customers , mainly in the USA but in EU and Japan.

This is an interim role.
Candidates must be experienced in biotech CDMO dealmaking .
If this opportunity is a good fit for you, please contact Geoff Newman at Interea as soon as possible.

 

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