Clinical Pharmacology Director

Ipsen Pharma

London, United Kingdom

Summary/purpose of the position

The Clinical Pharmacology Director is responsible for leading the Clinical Pharmacology program and strategy of assigned programs by:

Defining and implementing the Clinical Pharmacology Plan of NCE/NBE* to support the registration dossier;
Supporting in licensing of innovative assets into the Ipsen portfolio;
Providing scientific and operational support to clinical development studies (Ph1 to Ph4) and clinical pharmacology studies to be performed as part of any development program within Ipsen TAUs;
Interacting with Health Authorities.

The Clinical Pharmacologist sits on the Early Development team, Asset Team or clinical sub-team or other subteam on a case by case. *New Chemical Entity/New Biological Entity

Main responsibilities/job expectations

Define and implement Clinical Pharmacology strategy

Define and implement Clinical Pharmacology Plan of NCE/NBE to support the registration dossier;
Provide scientific and operational support to the Clinical Pharmacology studies (PK, QT, DDI, etc..) from study concept to reporting according to timelines, budget, operational and quality standards;
Accountable for Clinical Pharmacology input in study protocol, and operational implementation within a clinical study team including study conduct, point of scientific contact for study centers and CSR, in close collaboration with the respective Clinical Operations lead, Statistician, Pharmacometrician and MDD on the study.

Support in licensing of innovative assets into the Ipsen portfolio

Provide expertise for evaluation, acquisition & integration of external opportunities;
Assess opportunities & delivered development plan and risk mitigation plans for marketing authorization;
Contribute to transition plan and ensure proper asset integration into the Ipsen portfolio.

Contribute to documentation and communication on projects

Communicates all relevant information and propose adequate Clinical Pharmacology activities in accordance with clinical development Plan of the NCE/NBE;
Drafts and/or contributes to regulatory documentations in the context of regulatory authorities' matters, submissions or interactions with the Regulatory Authorities for the Clinical Pharmacology aspects. Participates in meetings with the Regulatory Authorities if required;
Lead presentation of the results at internal and external meetings; Contributes to the writing of publications, posters.

Monitor external Clinical Pharmacology activities

Supervises data analysis activities outsourced to external providers to ensure that analyses are conducted on time, within budget and within Ipsen quality standards;
Ensure appropriate documentation for clinical pharmacology tasks and ensure documentation of the eTMF for clinical pharmacology activities.

EHS responsibilities

Respect and enforce applicable EHS regulations and procedures;
Promote EHS dynamics within teams for the proper functioning of the EHS management system;
Participate in the prevention of accidents at work by carrying out the Managerial Safety Visits (VMS) of its employees;
Ensure the completion of mandatory EHS training.

Knowledge, abilities & experience

Education/Certifications

Minimum requirements/Education (minimum/desirable):

Desirable: PhD in pharmaceutical sciences/clinical Pharmacology or PharmD, with at least 8 years of industry experience in Clinical Pharmacology, preferably in oncology and rare disease;
Minimum: PhD in pharmaceutical sciences/clinical pharmacology or other relevant life sciences, or PharmD with at least 8 years of experience in clinical pharmacology, pharmacokinetics, drug development in an industrial setting;
An equivalent combination of relevant education and applicable job experience may be considered.

Experience

Strong analytical and problem-solving skills;
Excellent scientific written, interpersonal communication and networking skills with the ability to build cross functional bridges;
The ability to work with attention to detail in a time sensitive environment;
Strong familiarity with good clinical/laboratory practices (GxPs);
Experience working with CROs.

Languages

English: Business level, oral and written.

Key Technical Competencies Required

Knowledge & understanding of drug development processes (SM, PEP, BIOLOGICS, ...);
Understanding of needs and constraints in delivering Clinical Pharmacology activities for a clinical study;
Ability to analyze Clinical Pharmacology data in the setting of clinical studies and in respect of GCP;
Ability to perform PK analysis with dedicated software (Phoenix WinNonLin, SAS, R, …);
Ability to write and/or contribute to the drafting/preparation of regulatory documents (IB, clinical trial protocol, CTA modules, submission modules);
Strong people skills with the ability to communicate/interact at all levels within the business and with external partners;
Strong diagnostic, analytical and process improvement skills;
Organisational strategic awareness and proven ability of developing strategic solutions;
Strong leadership and line management capability and experience;
Excellent IT and Microsoft Office skills;
Strong attention to detail, excellent and direct communication skills, strong interpersonal skills, and cross-cultural understanding and sensitivity;
Managerial capability with strong leadership profile;
Ability to see the big picture, while keeping an eye on the detail;
Ability to represent the company in a highly professional manner;
Ability to take initiative with a positive attitude in all circumstances;
Flexible; independent problem solving and self-direction;
Eager and interested in learning and growing.