Senior Clinical Pharmacology Lead/ノンラインマネージャー or スタッフ/医薬開発本部臨床薬理部 (Kobe, Japan, Hyogo)

Basic purpose of the job

enior CPhL-Asia supports the clinical development in Asia of new drugs and further development of approved drugs with emphasis on the design and execution of the Clinical Pharmacology (CP)development strategy.

CPhL-Asia is accountable and responsible for communicating with regulatory authorities on CP topics and for CP aspects of drug submission in Asia (e.g., submission summaries).

CPhL-Asia may act as trial clinical Pharmacologist (TCP; see TCP job profile) for clinical studies in their own project or outside of their own projects.

CPhL-Asia may serve as Clin Pharm representative within various teams in Asia (Japan/China) in support of early integration of Japan/China into global development program. Post PoCP, they may serve as CP and TMCP representative in various Asian teams until submission and launch. CPhL-Asia will also serve as main TMCP representatives in all PMO projects in Asia.

Accountabilities

nsure timely delivery of state-of-the-art Clinical Pharmacology scientific concepts for decision making throughout clinical drug development and registration in Asia including all necessary processes and documentation.

Ensures timely delivery of state-of-the-art Clinical Pharmacology strategy development and implementation.

Senior CPhL-Asia is responsible for defining the CP strategy (for instance, defining the drug-drug interaction liability or formulation development strategy for modified release) of assigned project. CPhL-Asia is also responsible for refining the CP strategy in a timely manner as new data become available during drug development. As part of the strategy, CPhL-Asia may define CP aspects in a clin trial protocol and for an eventual submission and further phase IV activities.

Senior CPhL-Asia contributes to the Clin Pharm section of official documents (e.g., Information Brochure (IB), label); CPhL-Asia engages with regulatory agencies on matters pertaining to CP during drug development and are responsible for supporting Asian submission and post-submission activities with Clin Pharm and Biopharm expertise.

Clinical development project representative

Act as Clin Pharm representative in trial and project teams and regulatory meetings.

CPhL-Asia serves as Clin Pharm representative within various teams in support of early integration of Japan/China into global development program. Post PoCP, they may serve as CP and TMCP representative in various Asian teams until submission and launch. CPhL-Asia may also serve as main TMCP representatives in all PMO projects in Asia.

When delegating a trial to TCP, a CPhL-Asia is expected to ensure that adequate amount of information on the project and trial are provided to the TCP.

For instance, a CPhL-Asia is expected to discuss study design and project standards with the TCP.

A CPhL-Asia may function as a TCP in certain studies or projects.

Driving science and innovation

CPhL-Asia leads clinical development trial and project overarching topics from TMCP (e.g. by focus group).

CPhL-Asia represents Clinical Pharmacology or TMCP in internal and external initiatives/working groups.

CPhL-Asia continuously scouts, evaluates (incl piloting) and implements new methods and strategies in the area of Clinical Pharmacology.

Strategic partnerships:

CPhL-Asia implements collaborations and strategic partnerships with external bodies. They organize and manage projects with external organizations (e.g. CROs, ARO).

CPhL-Asia may serve as subject matter expert (CP, Biopharm) in in –or outlicensing activities

Functional processes:

CPhL-Asia continuously develops and refines further functional processes and infrastructure.

CPhL-Asia is CP (CP and Biopharm) experts and may offer this expertise to other interface functions (e.g, Toxicology, Pharmacovigilance, Customer Information, Marketing, Regulatory Affairs) or to support internal or external working groups.

CPhL-Asia presents results internally and externally as well as contributes to scientific publications.

Compliance (incl GCP):

CPhL-Asia follows all ICH GCP, other relevant authority regulations and BI internal guidance to protect the rights, safety and wellbeing of trial subjects, including sample chain of custody, data privacy and data integrity. In addition, obligations outside the field of clinical studies, such as EHS, Pharmacovigilance, anti-corruption, BI-internal guidance should be followed.

Minimum Education/Degree Requirements

Master's degree (or equivalent) in Medicine, Pharmaceutics, CP or equivalent area of focus with preferably 5-6 years of relevant experience in CP in the pharmaceutical industry, regulatory agencies, or academia could be considered for this position.

Doctoral degree (MD or PhD) in Medicine, Pharmaceutics or CP. Prior CP experience (around 2-3 years) in the pharmaceutical industry, regulatory agencies, or academia preferred.

Required Capabilities (Skills, Experience, Competencies)

Language skills: English: fluent (Read/Write/Speak).

Mindful of local, global, internal, and external cultures to ensure that messages are received positively and effectively.

Evidence of strong teamwork, also in global and remote context.

Good interpersonal skills with the ability to interact effectively with people, internally and externally (e.g., CROs, experts, management).

Ability to pro-actively identify issues and solutions and to interact with internal and external bodies on TMCP issues.

Ability to lead and facilitate meetings.

Ability to develop and deliver training related to TMCP topics required.

Experience working in the matrix, act in matrix leadership.

Very good knowledge in PK and PK/PD, Clinical Pharmacology, biopharmaceutics, clinical drug development and relevant regulatory guidelines. Good understanding of pharmacometric tools (modeling and simulation), their opportunities and limitations as well as basic understanding of statistical principles especially with respect to Clin Pharm trial data.

Excellent communication and presentation skills. Highly independent, diligent. The "integrator" role requires a high standard in

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