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Global Development Program Head - Sr. Clinical Development role

Job Title: Global Development Program Head - Sr. Clinical Development role
Contract Type: Permanent
Location: Switzerland, Switzerland
Industry:
Salary: benefits package
Start Date: Q4 2018
Reference: 72270-PHARM-VLB_1534531035
Contact Name: Vladyslav Babych
Contact Email: Vladyslav.Babych@volt.eu.com
Job Published: August 17, 2018 19:37

Job Description

Job Title: Global Clinical Program Head
Department: Clinical Development
Reports to: Head of Clinical Development
Oncology, cardiology and neurology; gastrointestinal diagnostic

Primary tasks and responsibilities:
1) Leads the GCT, represents Clinical Development on the Global Program Team (GPT)
2) Contributes to overall development strategy as a member of the extended R&D leadership
team
3) Leads the clinical development and execution of the clinical strategy.
Develops an endorsed Integrated Development Plan (IDP) in line with the Target Product Profile (TPP) which is designed for successful global regulatory approval/market access for one or multiple treatment indications and/or multiple programs
4) Leads the creation of clinical components of key documents (e.g., Clinical Trial Protocols (CTPs), Investigator's Brochures, Clinical Study Reports (CSRs), regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers) with high quality and consistency with IDP and TPP. Supports registration, market access, commercialization, and maintenance of product licenses (e.g., Core Data Sheet, Periodic Safety Update Report, clinical benefit-risk assessment for license renewals) for the compound(s)
5) Together with Patient Safety, ensures continuous evaluation of the benefit-risk profile,
including safety monitoring of clinical studies and signal detection from post-marketing surveillance.
Serves as a core member of the Safety Management Team (SMT)
6) As the medical expert, leads and contributes to interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Global Medical Affairs (GMA), Marketing, Health Economics & Outcomes Research), and internal decision boards
7) Serves as a core member on the Protocol Review Committee to support the Head of Clinical
Development with the peer-review of IDPs, CTPs, and other clinical documents across various
indications and programs; and with driving excellence across clinical trial strategy, design, and execution
8) May contribute to development of the overall development strategies
9) Plans and executes publication and clinical communication strategy in coordination with GMA and Medical Writing, and provides input into key external presentations
10) Drives scenario development for Clinical Development to support decision analysis and optimal resource allocation in program(s)
11) Ensures career development of program reports through active participation in the
performance management, talent review, and succession planning processes. Provides on-boarding, coaching, and/or mentoring support; develops and fosters Clinical Development culture; and contributes to the performance evaluation of GCT members
12) Responsible for medical/scientific training of relevant company stakeholders on the disease area and compound/molecule. May serve as speaker for medical/ scientific training
13) Leads or serves on global process improvement work streams, act as Subject Matter Experts for standard operating procedures or trainings, and/or contributes to other cross-functional or Clinical Development line function initiatives
14) May serve as the Clinical Development Representative on Research project teams to drive
transition of pre-PoC (Proof of Concept) projects to Development
15) May support Business Development & Licensing (BD&L) activities

Job Dimensions
Number of associates: Leads a team of up to 50 direct and indirect reports
Financial responsibility: Overall lifetime clinical budget of program which can vary and be in excess of $100 million

Desired Requirements:

Education:
● MD or equivalent (preferred), PhD, or PharmD degree required.
● Advanced clinical training/knowledge in medical/scientific area aligned with TA required. ● Medical Board certification preferred for MD or equivalent;
● Clinical practice experience ≥ 4 years (including residency) preferred for MD or equivalent

Experience:
● ≥6 years (MD or equivalent)/ ≥ 10 years (PhD or PharmD) of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers
● Advanced knowledge of assigned therapeutic area required, with the capability to innovate in clinical development study designs that provide relevant evidence to decision-makers, and to interpret, discuss and present clinical trial or section program level data
● Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and
regulatory/clinical development process
● Experience with submissions and health authorities required
● Demonstrated ability to establish strong scientific partnership with key stakeholders
● Demonstrated leadership and management skills with a documented track record of delivering
high quality projects/submissions/trials in a global/matrix environment (including remote) in pharmaceutical or biotech industry
● ≥ 5 years people management experience required, this may include management in a matrix
environment
● Considerable organizational awareness including significant experience working crossfunctionally and in global teams
● Excellent management, interpersonal, communication (both written and oral), and problem
solving skills
● Excellent negotiation and diplomatic skills