Job Title: Clinical Research Director

Location: Berkshire OR Wales

Job Reference: JR 25359

If you’re an experienced Clinical Research Physician / medically qualified clinical research leader and you’d like to hear about a really unique opportunity with a business developing novel, life changing products I’d love to hear from you.

Our client is a leading edge company with an exciting pipeline focused on developing clinically challenging products in oncology and immune related rare diseases, using their innovative drug delivery technologies. They are at the forefront of developing new nano and micro drug delivery technologies to generate medicines that address unmet medical needs.

They are growing and evolving and as a result they are recruiting for a Clinical Research Director to drive and manage ongoing early phase clinical programmes.

The role will report to the EVP R&D. The primary focus will be to provide leadership and direction for the company’s R&D portfolio and clinical development programs in autoimmune rare diseases and oncology. The role holder will be a key member of the senior management team, which determines and oversees research and development and sets the overall strategic direction of the company. You’d be providing practical clinical science and medical input to the company’s clinical development programs. This is a unique opportunity to be a major contributor to the success of a well-positioned, high technology, R&D led biotechnology company.

Example of duties include

·Develop a detailed understanding current standards of care, emerging products, areas of unmet need, competitive landscape and regulatory authority therapy area requirements

·Explain and defend the company’s position in interactions with stakeholders such as investors, health authorities (i.e. FDA. EMA), pharma partners and KOLs

·Develop and maintain a network of global key opinion/thought leaders, investigators and other clinical stakeholders who can provide cutting-edge advice on development candidates; lead Key Opinion Leader activities including advisory boards

·Provide clinical input into Target Product Profiles (TPP) that to position products optimally in the market place relative to current and emerging products

·Direct development of clinical strategies and plans to ensure products meet their TPPs

·Direct the development of clinical regulatory strategies and interactions with Drug Regulatory Authorities

·Lead the clinical science input into the design of study protocols, investigator brochures, clinical publications and regulatory submission documentation

·Be an active member of the project team, contribute to and/or lead the assessment of the benefit/risk profile of drug candidates

·Offer clinical/medical leadership to internal staff and external partners

·Lead the clinical/medical review and interpretation of data for clinical study reports

·Work with internal and external partners to execute global clinical trial strategies, achieve the company’s strategic and tactical goals

·Identify, assess and participate in due diligence of collaboration or investment opportunities for the company, assist in business development activities for the organisation

·Engage in peer to peer discussions with pharma partners as the clinical subject matter expert throughout product development, business development activities, to educate pharma partners and investors and other stakeholders on the merits of drug candidates

·Prepare abstracts, presentations and manuscripts, work with relevant team to generate and/or review medical and scientific information materials including scientific publications, abstracts, posters, and whitepapers relating to the business

Qualifications: Education/Experience

·MD qualified ideally with oncology or rare disease training and experience

·Ideally multiple years of experience in clinical research treating patients

·Experience leading clinical/medical programs in a biotech/pharmaceutical R&D environment working on investigational new drugs

·A proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND’s and marketing applications (BLA’s, NDA’s, and MAA’s)

Knowledge, Skills and Abilities:

·Knowledge of relevant FDA and EU regulations and guidelines

·Experienced in interactions with FDA and EU Agencies

·Experience / strong knowledge of oncology and rare disease drug development

·Knowledge of translational medicine, clinical pharmacology and early stage development desirable

·Demonstrated experienced in the design of clinical development programs and trial designs to support clinical ‘proof of concept’ and achieve successful product registration

·Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines

·Excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company

·Science- and data-driven

·Ability / desire to “make things happen”, results-oriented work ethic and a positive, can-do attitude

·The highest personal values and ethical standards

If this sounds like you it’d be great to have a conversation.Please apply as directed and suitably qualified applicants can expect a very prompt and positive reply!