Posted on: 16/06/2017

Job type: Permanent

Sector: Pharmaceutical and Healthcare

 
Sign up for job alerts

You will receive job alerts for:

Please enter your email address.

The person will drive the clinical development strategies and plans including for Phase II,III and IV clinical programs across all therapeutic areas.

Description

* This is a high impact position with great visibility across all levels of the organization with the primary role of driving clinical development portfolio.
* Specifically, this position will have a critical hands-on leadership and mentoring of clinical MD and PhD clinical scientists and biostatisticians.
* The Vice President will drive the clinical development strategies and plans including for Phase II, III and IV clinical programs across all therapeutic areas.
* Key domains include study protocols, biostatistical approach, medical review of clinical trial data and generation of clinical study reports.
* The Vice President will interact externally with key global regulatory authorities, industry organizations and scientific organization.
* This position will work cross-functionally to ensure projects coordinated partners from multiple departments including preclinical pharmacology and toxicology, CMC, project management, patient engagement, health economics, supply chain, regulatory, legal, finance, new product planning, marketing and others.

Responsibilities

* Primary leadership role for clinical development strategy in protocol design across multiple late-phase clinical research trials across one or several therapeutic areas.
* Direct authorship of protocols and clinical study reports.
* Lead and motivate clinical development staff including multiple MD and PhD trained employees.
* Oversee hiring additional staff as needed.
* Interact with senior management and serve as a standing member of the Clinical Development Leadership Team, and Product Development Team.
* Serve as a primary internal and external spokesperson for the responsible clinical development programs.
* Represent the company to external audiences in the clinical, financial, and pharmaceutical industry communities and organizations.
* Generate yearly strategic goals and objectives for the department
* Oversee and coordinate the operational aspects of ongoing projects to ensure that goals of time, cost and quality performance expectation are met.
* In collaboration with internal or external clinical operations, project management and finance staff, generate study and departmental budgets; complete other administrative tasks as required.
* Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research protocols and are compliant with clinical/medical and industry standards.
* Identify and develop collaborative relationships with key investigators and key opinion leaders globally. Attend and oversee clinical advisory boards and investigator meetings.
* Critically review regulatory submissions (such as INDs and NDAs).

Skills, Education And Experience

* Requires a Medical Degree or equivalent preferably with focus in Immuno-oncology area.
* Excellent writing and presentation skills.
* Strong leadership and collaborative interpersonal skills.
* 10 + years of experience in the bio-pharmaceuticals. Experience with successful NDA submissions and approvals and interactions with regulatory agencies is highly desired
* Knowledge of safety reporting principles, including global safety reporting regulations
* Able to work independently, prioritize tasks efficiently and meet expected time frames.
Send job by email