Clinical Scientist

Pulmonary Hypertension Development TA

POSITION TITLE: Senior Clinical Scientist (Level 30)

The focus of this position is to plan, design, scientifically monitor and report clinical studies.
The incumbent is responsible for the compliance of the assigned clinical study(ies) with department, company and regulatory standards and procedures.

PRINCIPAL RESPONSIBILITIES:
1. Is responsible for delivering the clinical study protocol and contributes to the development of other clinical study
documents, e.g. Informed Consent Form, Case Report Form, etc.
2. Plans, manages and monitors daily activities of clinical studies which require scientific input, e.g. contribution to
answers to trial-related Health Authorities' (HA) questions, answer to Ethic Committees /Institutional Review
Boards questions, etc.
3. Performs medical monitoring/ reporting including evaluation of adverse events.
4. Reviews, evaluates and reports results of clinical studies.
5. Manages study-related committees, external medical experts etc.
6. Ensures that all activities are in compliance with department, company and regulatory standards and
procedures.
7. As requested, contributes to the development and execution of clinical research programs for assigned
company products, e.g. Clinical Development Plans, Clinical Overviews, HAs' Briefing Books, HAs' Annual
Reports, Pediatric Investigational Plans, etc.
8. As requested, participates on cross functional teams, e.g. improvement of processes, etc.

PRINCIPAL RELATIONSHIPS:
Cross-functional Trial Team: GCDO Trial Leader, Clinical Scientists (i.e. Study Responsible Scientist), Clinical
Trial/ Project Physicians (i.e. Study Responsible Physician)
Contacts Inside the Company: Clinical Pharmacology, Global Clinical Development Operations, Health Economics &
Pricing, Global Medical Safety, R&D Project Management Organization, Quality Management, Quantitative Sciences,
Regulatory, Trial Supply Management, other departments as needed.
Contacts Outside the Company: Vendors and CRO contacts, academic thought leaders, FDA, European and other health authorities as appropriate.
Supervision: This position reports to a Scientific Leader or Principal Clinical Scientist as assigned.

EDUCATION AND EXPERIENCE REQUIREMENTS:
1. PhD, PharmD, DVM, MSc (or equivalent) degree in Biological Sciences required.
2. At least 5 years experience in Clinical Development, and hands on experience on conducting clinical trials.
3. Knowledge of clinical development processes, clinical trial processes, and regulatory requirements/ ICH
guidelines based on previous deliverables.
4. Prior experience of working in a matrix organization including interactions with all relevant functions involved in
a clinical trial and program (e.g. Biostatistics, Data Management, Operations, Regulatory, Drug Safety, external
service providers, etc.).
5. Good leadership skills.
6. Demonstrated analytical skills.
7. Excellent computer systems and software skills.
8. Excellent English, other languages advantageous.
Competencies
1. Good organizational skills, good written and verbal communication skills, able to work as part of a team and
independently
2. Good independent time management skills
3. Ability to plan and track deliverables and timelines
4. Ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the
business.
5. Detail oriented.