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Clinical Research Scientist / Medical Director

Posted 1 hour 56 minutes ago by Mestag Therapeutics

Permanent
Full Time
Research Jobs
Essex, Little Chesterford, United Kingdom, CB101
Job Description
Clinical Scientist / Medical Director

Full Time Permanent - Hybrid and on-site working - Flexible on presence.

On Site Parking - Full benefits package.

Scope of role

We are seeking an experienced Clinical Scientist/Medical Director to provide clinical leadership for MST-0312, our lead oncology asset currently in Phase 1 development in solid tumours.

Reporting to our CMO, this individual will act as the clinical lead for the programme, providing day to day medical and scientific oversight of the ongoing study, contributing to development strategy, and representing Mestag externally with investigators, key opinion leaders, and regulatory authorities.

This is a hands on clinical leadership role suited to someone who has previously taken full ownership of an oncology clinical programme, from protocol concept through to Clinical Study Report and who is comfortable operating in a small, fast moving biotech environment. The role provides the opportunity to lead clinical strategy & execution for an active, clinical stage oncology programme at a critical stage of development.

Key Responsibilities
  • Serve as clinical lead for the MST-0312 programme, providing scientific and medical direction for the ongoing Phase 1 solid tumour study. Represent the clinical science function on the project team and subteam(s).
  • Partner with the CMO to shape overall clinical development strategy for MST-0312, including evaluation/monitoring of the development & commercial landscape in which the programme is operating.
  • Partner with the leadership team & project leader on development of target product profiles for the molecule in the indications selected.
  • Provide clinical oversight of sponsored trials, including protocol interpretation, safety review, and eligibility/data queries in conjunction with the CRO medical monitor and safety team.
  • Lead or significantly contribute to the clinical sections of regulatory submissions, including INDs/CTAs, briefing documents, and responses to regulatory authority queries.
  • Author or oversee authorship of pre IND (or equivalent pre submission) briefing materials for interactions with major regulatory authorities.
  • Lead protocol, investigator brochure, DSUR & CSR development, partner with clinical operations lead on informed consent documents and study plans.
  • Build and maintain relationships with investigators, clinical sites, and key opinion leaders in relevant oncology indications to support trial execution, scientific credibility, and future development planning.
  • Represent Mestag at scientific conferences, advisory boards, and investigator meetings.
  • Collaborate cross functionally with clinical operations, biostatistics, regulatory affairs, pharmacovigilance, and translational/biomarker teams.
  • Support data interpretation, abstract/manuscript development, and presentation of clinical results.
Qualifications and Experience Required
  • For the Medical Director: Hold a Medical Degree such as MBBS, MBChB, MD or equivalent with the required experience.
  • For the Clinical Scientist: A bachelor's degree or higher with the required experience.
  • Direct experience having taken a clinical study through its full lifecycle, from pre protocol concept and design through to final Clinical Study Report (CSR).
  • Substantial prior experience working in solid tumour oncology.
  • An existing, active network of key opinion leaders (KOLs) in relevant oncology therapeutic areas.
  • Experience authoring clinical sections of a pre IND briefing book, or equivalent pre submission briefing package, for interaction with a major regulatory authority (MHRA, FDA, EMA, or similar).
  • Strong understanding of GCP, clinical trial regulations, and drug development processes in both early (Phase 1) and later stage oncology settings.
  • Experienced in oversight of real time clinical trial data, either from CRO or sponsor side.
  • Excellent written and verbal communication skills, with experience presenting to internal leadership, external investigators, and regulatory agencies.
  • Ability to operate effectively in a small company environment, adaptable, balancing strategic input with hands on execution.
Desirable
  • Prior experience in a small or mid sized biotech, particularly in a company building out its clinical function.
  • Experience with immune oncology clinical development.
  • Experience with adaptive or biomarker driven trial designs.
Benefits

We offer a highly competitive total rewards package including competitive salaries, pension contributions, private medical insurance, income protection and more. We have access to onsite facilities such as a gym, canteen, golf course and free on site parking.

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