Mission Therapeutics is an early-stage drug development company targeting the ubiquitin pathway for the treatment of neurodegenerative disease, rare mitochondrial diseases and fibrosis. The Company has built a leading platform for the discovery and development of first-in-class, small molecule drugs that selectively target deubiquitylating enzymes (DUBs) – an emerging drug class that is attracting significant commercial interest in the area of protein homeostasis.
The Clinical Director will be the key individual designing the clinical program(s) in the assigned indication(s). Based on in-depth understanding of the disease area and the molecule under study they will design protocol(s) within the clinical development program leading to the achievement of the eventual target product profile. They will be accountable for the scientific strength of the protocol / program and will be the key person interpreting, interrogating and reporting the data, both internally and externally, including suggesting and developing further analyses which may be required or desired.
This will be a highly visible role with considerable scope for growth and increased responsibilities for the right individual.
Key Responsibilities of the role will include
• Provide strategic clinical guidance for the development of Mission compounds in the assigned therapeutic / indication, serving as the major initiator of the PoC strategy and the early Clinical Development Plan (CDP).
• Design the clinical development strategy for assigned compound(s).
• In collaboration with other team members, design the protocol(s) leading to the elucidation of the clinical profile and achievement of the target product profile for assigned compound(s).
• Provide Medical oversight of assigned protocols.
• Ensure the appropriate instruments are in place to implement, interpret and report clinical studies (e.g., case report forms, analysis plans, clinical study reports).
• Apply their medical knowledge to guide the safe, ethical and efficient conduct of the assigned clinical trials.
• Liaise with outside experts, investigators, and regulatory authorities in the assigned field, and represent projects to those groups and authorities.
• Provides direct or supervisory medical support for all pharmacokinetic studies.
• Contributes senior-level expertise as needed to Research in support of target selection, target validation, and preclinical development of compounds.
• Interact effectively with external key opinion leaders to build and optimise support for Mission development programs.
• Mentor colleagues on scientific, clinical, and drug development issues as appropriate.
• Anticipate or identify project needs and maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements.
• Responsible for overall content of clinical reports.
Qualifications, Skills and Experience
• Medical degree with experience in area of therapeutic focus. Postgraduate qualification would be beneficial
• At least 5 years’ experience in clinical development in biotech or pharmaceutical industry.
• Flexible, fast learner, and willing and able to assume extra responsibilities
• Previous experience of developing protocols from idea to execution
• Excellent verbal and written communication skills
• Ability to thrive in fast-paced biotech environment
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.
• Proactive and positive, problem-solving approach
• Experience of regulatory authority interactions would be a benefit
• Authoring relevant sections of regulatory documents (e.g. IB, Scientific Advice positions, Clinical Trial Applications) would be a benefit
We offer a competitive salary along with a contributory pension scheme and other excellent benefits.
If you would like to apply for the position, please send your CV with a covering letter to email@example.com.
The closing date for applications is 31 January 2022.
In order to comply with UK employment legislation, all applicants for positions at Mission must have the right to work in the UK. In the event that a job offer is made, you will be required to provide evidence of your right to work in the UK before you commence employment with Mission.
All applications received will be managed in accordance with our Job Applicant Privacy Notice available to view on the Careers page of our website www.missiontherapeutics.com
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