Drug Development Director, Projects (Oral Dose & Injectable)
|Job Title:||Drug Development Director, Projects (Oral Dose & Injectable)|
|Contact Name:||Larry O’Leary|
|Job Published:||almost 2 years ago|
Our client is a highly ambitious young Irish pharmaceutical company with a highly entrepreneurial management team with an impressive track record in acquisitions, commercialisation, licensing, formulation and product development in building highly successful global businesses. Its strategy is to develop technologies through late-stage development and regulatory filings, expanding their existing product portfolio in focused therapeutic areas, to patients with unmet needs. Additionally this company are revenue generating which brings financial security.
Main scope of this role:
The successful candidate will play a critical part of managing development programs to achieve milestones on-time and on-budget. The skillsets associate with this role include expertise in development program project management, CMC expertise including formulation, manufacturing and technical writing to support development reports and required regulatory authorizations. Additional experience in nonclinical/clinical development a plus.
This role will also be involved in the drafting of RFPs, bidding/negotiating RFPs to gain competitive pricing and timelines, and selection and management of vendors to complete the work within agreed budgets and timelines.
Lastly, this role will ultimately be responsible for the timelines and many critical technical and programmatical decisions required developing new products and filing for regulatory approval. In this role, the person should expect regular interaction with the Leadership Team, Board of Directors and Technical Advisors to the company.
Requirements for Drug Development Director, Projects:
Bachelor's degree in a technical field. Advanced degree strongly preferred.
10 years+ product development experience in pharmaceutical, biotech or specialty pharma companies
Knowledge of a wide variety of vendor capabilities and prior contacts and working relationships already established
Successful track record of building constructive relationships with all stakeholders and team members including management, peer-group, and cross - functional team members/reports
Proven influencing skills on outside partners and potential partners
Significant experience in the technical aspects of drug development
Knowledge of the regulatory requirements to obtain approval for pharmaceutical and medical device products
Excellent project management and negotiation skills; project/portfolio management; demonstrated expertise in supportive tools.
Demonstrated ability to accurately gauge the urgency of an issue and proactively manage the actions required to make successful decisions within aggressive timelines
Superb judgment and capable of solving complex problems
Excellent oral and written communication skills
Willingness and appetite for travel
Please phone Larry on +353 1-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Follow us on: Facebook, Linked-in, twitter
Sorry, this job post it's no longer available
Senior Scientist - Analytical Development
Regulatory Affairs CMC Manager
Strategic Regulatory Affairs Specialist, Clinical & CMC
Clinical Study Manager - 6 month contract role
Clinical Trial Liaison, EU region (based in Dublin)