Senior Clinical Development Leader

April 17, 2019


Company

Bayer USA

Industry

Pharmaceutical and Biotechnology

Category

Other

Location

Whippany NJ or Boston MA


Description

 

Your tasks and responsibilities

The primary responsibilities of this role, Senior Clinical Development Leader, are to: 

Execution and delivery of the clinical development plan in collaboration with other cross-functional team members;

The incumbent is responsible for developing drugs safely and effectively:

Translate Target Product Profile into clinical strategy;

Responsible for study medical/safety aspects and risk-benefit assessments; supported by Pharmacovigilance (PV) and CDS

Assess and ensure validity of efficacy data;

Interpret medical data to identify possible patient safety and data integrity issues; is primary contact for study medical and patient safety aspect;

Lead and manage relationship with key internal/external stakeholder (eg Study Team, Key Opinion Leaders (KOL), health authorities);

Responsible for medical section of protocol, train internal/external stakeholder (eg Study Team, Site Staff) and perform the protocol review during the site initiation visit;

Ensure Clinical Study Report (CSR) medical content adheres to acceptable medical standard;

Individual may be representing the team to other decision/governance meeting, senior management or advisory boards as applicable;

May be responsible for supervising/mentoring multiple studies/clinician.

Requirements

Required qualifications:

MD required;

Ideal candidate will have experience in several of the following areas:

Experience in exploratory clinical drug development specific to Oncology;

Experience in the drug development and commercialization process;

Understanding of the complexities and recent developments in the oncology;

Understanding of issue related to the design and performance of technologically demanding trials;

Confident to discuss scientific/mechanistic aspects of drug development;

Familiar with the regulatory and legal environment;

Strong communication skills (fluent in English both written and spoken) to ensure that project plan and status are transparent; risk, issue and result are clear to all involved parties;

High level of comfort/success working in a matrix environment (global/multi-cultural/cross-functional);

This includes contributing to a trust environment: clarity, collaboration and results oriented;

Demonstrated leadership skills both as an individual contributor or team leader;

Networking and alliance management.

Preferred qualifications:

PhD in addition with 5-8 yrs experience;

Specialized experience in Oncology strongly preferred;

Board certified in Oncology strongly preferred

Fortune 1000 Company?

Yes

Job Type

Full Time

Career Level

SVP, EVP, VP, Tax Director, Internal Audit Director, Control

Travel Requirements

10%

Contact Name

Debra Lopez Quiat

Contact Phone

+1 412-777-2903