Senior Director – Neurology


Contact Form Shortcode Error: Form 4 does not exist

Position Description

 

The Director /Senior Director is part of the discovery medicine group within Discovery Performance Unit (DPU), reporting to the DPU physician lead or head of DPU, R&D China. This group is fully accountable for the early clinical development of new compounds within neurology pipeline for the treatment of neurologic disorders, i.e. from Candidate Selection to Proof of Concept (PoC) clinical trials of efficacy in patients.

 

The Director / Senior Director, Discovery Medicine is accountable for the production of clinical development plans, PoC strategies and design and coordination of study protocols from First Time in Human / First Time in Patient (FTIH / FTIP) up to and including PoC Phase II clinical trials with the support of the team and DPU head.   Clinical development plans and study protocols will incorporate appropriate enabling technologies (e.g. neuroimaging, clinical electrophysiology, applied molecular medicine, pharmacogenetics), modelling and simulation, models and surrogate markers to support the relevant neurology projects. The working style of this job will require the incumbent to work in large teams and in partnerships with other clinical and preclinical functions. The Director / Senior Director, Discovery Medicine is also expected to work in close collaboration with the best academic centers.

 

Responsibility for clinical standards, discipline, excellence and appropriate timelines for DPU activities are an important component of the role. The Director / Senior Director, Discovery Medicine represents physician discipline for DPUs on project and strategy teams, including leading project teams and clinical matrix teams, as appropriate.

 

Summary of Key Responsibilities:

 

Accountable for the development of Clinical Plans for Phases I and IIa studies from FTIH through to PoC / Commit to Medicines Development, and responsible for PoC strategy with relevant functions.

 

Accountable for study design, concept protocols and data analysis strategy for all studies from FTIH through to PoC / Commit to Medicines Development, ensuring optimal use of PK/PD, safety, and pre-clinical data. Integrate with support groups (data sciences/ statistics, regulatory, safety evaluation) to ensure that FTIH and subsequent studies are conducted to appropriate corporate and regulatory standards.

 

Accountable for ensuring that all critical clinical development issues are brought to the attention of the DPU head and that programs and projects are adequately resourced.

 

Contributes to securing appropriate budget and resources for the implementation of the clinical plan, working with the Project Team.

 

Contributes to provision of expert scientific and clinical review of full protocols produced by the relevant functions. Agree study site placement and timelines with the relevant functions and co-ordinate academic affiliations and collaborations in consultation with the relevant functions.

 

Responsible for the conduct of Phase I and IIa clinical studies with the relevant functions.

 

Contributes to the conduct of clinical pharmacology studies post-POC with the relevant functions.

 

Contributes to the development and implementation of the Discovery Medicine biomarker/ surrogate marker strategy and the use of appropriate enabling technologies in partnership with the relevant functions (Translational Medicine, Clinical Operations, Clinical Pharmacology Modelling and Simulation, Platform Technology, and Biology/Chemistry etc.).

 

Contributes to management of issues arising from ongoing studies (e.g. adverse events, unexpected PK), with timely identification, implementation and communication of appropriate actions, following global R&D medical governance policies.

 

Contributes to authorship or major contribution to key documents such as Clinical Investigator Brochure (CIB), INDs, CTX/ CTAs and publications in biomedical/scientific journals in collaboration with project team and colleagues.

 

Contributes to clinical review of in-licensing opportunities, and production of clinical development plans related to such, where necessary.

 

In addition to the above, medically qualified Directors / Senior Directors, Discovery Medicine, who comply with the criteria of company Medical Monitors, are accountable for the provision of medical input into project plans, study design and protocols for pre- and post- PoC projects.

 

Candidate Profile

 

Work Experience & Abilities Required:

 

Minimum 8 years pharmaceutical industry experience.

 

Experience in clinical medicine and/or scientific research, industrial clinical pharmacology and drug development experience required.

 

Therapeutic experience relevant to neurosciences (neurodegenerative and neuroinflammatory diseases preferable) required.

 

Experience and understanding of taking NCEs through early phases of clinical development.

 

Knowledge of the principles of developability and project management for candidates.

 

Clear understanding of technical aspects relevant to early drug development in the pharmaceutical industry.

 

Ability to recognize and exploit the need for enabling technologies within the context of clinical pharmacology studies.

 

Evidence of good clinical and project judgment.

 

Ability to interpret the significance of preclinical and clinical results, and to anticipate the information that will be needed to satisfy regulatory requirements for clinical studies.

 

Ability to manage study budget and timelines, and progress drug candidates safely and efficiently.

 

Demonstrated ability to take lead role in compound progression through different phases of clinical development.

 

Interacts effectively across boundaries with other functions and disciplines using influencing, communication and relationship building skills.

 

Ability to secure, manage and maintain critical partnerships with key business partners.

 

Commitment to anticipate, influence and implement change, handle outside influences on projects (competitor information, opinion leaders etc.).

 

Builds contingencies in project or development plans to provide flexibility.

 

Education:

 

M.D. (Western trained or equivalent).

 


For more information regarding this position, please contact Ms. Jessica Blackwell by filling out the form below.

 


This entry was posted in Foster Partners Current Assignments, Foster Partners Life Sciences Current Assigments. Bookmark the permalink.

Comments are closed.