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Executive Director, Clinical Development Physician

4 months ago

Rockville, United States American Society of Clinical Oncology Full time

This is a unique role to develop and lead the end-to-end melanoma strategy across the portfolio for Immunocore, the only commercial stage T cell receptor company.

The Melanoma Global Development Lead will report to the Head of Oncology Clinical Development and is primarily responsible for the strategy, design and execution of all registrational and late-stage melanoma clinical programs. Key will be representing Immunocore externally and leading all interactions with a diverse range of global, scientific and clinical melanoma experts.

As Immunocore is a nimble commercial stage biotech, they must have a ‘player-coach’ mentality and be able and willing to balance both leading a team strategically and assume an individual contributor role on protocol development and clinical trial execution.

KEY RESPONSIBILITIES

• Lead the melanoma strategy for Immunocore, from discovery through registration in close collaboration with other key leaders from Research, Regulatory, Portfolio Strategy, Translational Medicine, Medical Affairs and Commercial

• Serve as the internal melanoma expert for the company

• Lead a cross functional team(s) to design and execute innovative registrational and late-stage melanoma trials, from trial concept, site selection, data collection and analyses, ongoing safety review, clinical interpretation, publication and, where appropriate, regulatory submission

• Serve as the Medical Monitor on one or more studies

• Author and review clinical documents required for the conduct of clinical trials

• Build and lead strong relationships with external melanoma experts, including scientific advisory boards and collaborations, and maintains high level and standard of scientific and clinical knowledge in melanoma cancer

• Complies with all governing laws and regulations, SOPs and any other guidelines as required

Other

• This individual will be an effective leader and mentor to the clinical development team and provide guidance to the junior members of the team as deemed necessary.

• The individual will also lead relevant health authority interactions and provide a strategic melanoma perspective to target discovery, translational medicine, and relevant non-registrational early-stage clinical programs.

• The Lead will lead cross-functional melanoma clinical trial teams, including clinical trial design and execution, data interpretation, and presentation.

PERSON SPECIFICATION

Experience & knowledge

Essential

• At least 6 years biopharma experience, with strong working knowledge of the clinical drug development process and experience in the conduct/participation of clinical trials including experience in melanoma clinical trial development

• Expertise/deep understanding of the melanoma landscape, including current and emerging treatments

• Experience in immune-oncology and/or T-cell therapies

• Thorough understanding of clinical research methodology and biostatistics principles

• Good working knowledge of Microsoft applications such as Excel, Access, Word, and Outlook.

• Good Communication skills - Ensuring information and work is passed on correctly and in a timely way to those who depend on it.

• Shown flexibility and willingness to learn new techniques and practices.

• Following instructions and protocols

• Maintenance of accurate records

• Teamwork - Working cooperatively as part of a team

Desirable

• Experience with health authority interactions and negotiations

• Previous experience with BLA/MAA submissions

• Experience in Phase 1 and 2 clinical trials

• Understanding of translational medicine and integration with IO development

• Experience with strategic development across a portfolio

KEY BEHAVIOURAL ATTRIBUTES

• Openness and honesty

Readily offering information pertaining to work in hand whether positive or negative.

• Taking responsibility

Being prepared to accept full responsibility for tasks entrusted to them; seeing tasks through to completion and dealing with the consequences of failure or success.

• Flexibility

Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities. Handling disjointed tasks effectively.

• Team spirit

Being able to work productively with others to achieve tasks. Showing consideration for the needs and feelings of others.

SPECIFIC BEHAVIOURAL ATTRIBUTES

• Attention to Communication: Ensuring information and work is passed on correctly and in a timely way to those who depend on it.

• Written & Oral Communication: Writing and speaking clearly to share thoughts and information concisely and appropriately.

• Diagnostic Information Gathering: Identifying the information required to clarify a situation, asking questions when required.

• Results Orientated: Focusing on desired results, seeking help and support to overcome obstacles in a timely manner.

• Thoroughness: Ensuring work and information provided is complete, carefully checking and seeking additional support to help achieve this if needed.

• Managing Self Performance: Works to specific and measurable goals, seeking support and advice when dealing with unfamiliar or new issues.

• Analytical Thinking: Tackling day –to-day problems using a logical and systematic approach, identifying discrepancies and inconsistencies.

Education & qualifications

Medical degree with board certification (or equivalent), preferably in oncology

Other

• Strong people leadership abilities

• Experience working with relevant functions to develop and execute on a clinical development strategy

• Demonstrated ability to critically evaluate medical/scientific information

• Demonstrated ability to prioritize in the face of multiple competing priorities

• Must work with professional discretion and confidentiality

• Ability to work independently and think outside the box and problem-solve clinical trial issues

• Result and deadline orientated

• Excellent presentation skills

• High credibility

This position is eligible for standard Company benefits, including medical, dental, vision, time off and 401k, as well as participating in Immunocore's annual incentive plans. Incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level.

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