Senior R&D Director

Adalvo, we're not just a company - we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, fast and always on target, we are Adalvo

We are looking for a Senior R&D Director to join our dynamic Adalvo team. This position offers an opportunity to well-suited candidates to join a growing, fast paced energetic environment and culture.

SUMMARY OF POSITION

The Senior R&D Director will be responsible for overseeing the formulation & analytical developments and monitoring all the related R&D activities of the assigned projects. Further the position will be responsible for providing scientific leadership and operational oversight of the assigned R&D projects. The Senior R&D Director will work collaboratively with cross-functional teams to drive the development of assigned new products and ensure their successful development from pre-formulation development through regulatory approval.

ORGANIZATION STRUCTURE

This role will report directly to the SVP, R&D and Clinical.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

• Manage the assigned R&D team members in the execution of the development programs for generics and 505(B2).
• Provide scientific and technical expertise in the development of new products for EU, US, BR, CA, and other highly regulated markets.
• Develop and implement R&D strategies to advance the company's pipeline and achieve key business objectives.
• Responsible for technical contribution to the development strategy, planning and implementation of all the assigned development programs.
• Ensure the timely delivery of high-quality, scientifically sound, and innovative drug candidates for development.
• Manage and develop a high-performing R&D team, providing mentoring, guidance, and coaching to promote career growth and development.
• Manage R&D budgets, resource allocation, and timelines, ensuring effective alignment with corporate goals.
• Work closely together with internal and external cross-functional teams, e.g., PMO, CMC, RA, Intellectual Property, Production, Quality, Portfolio Management, Strategic Partnership and Business Development.
• Strictly follow all the relevant established international pharmaceutical quality and regulatory standards.
• Provide scientific and technical expertise in the development of solid oral dosage form, topicals, injectables and inhalers for EU and US market.
• Provides guidance, mentoring, and development of staff; ensures the team has appropriate skills, capabilities, and resources to meet current and future business needs.

QUALIFICATIONS & REQUIREMENTS

• MS in pharmaceutical science, chemical engineering, or equivalent scientific discipline. PhD is an asset.
• At least 20 years of experience in pharmaceutical technical development disciplines, with a track record of successful leading of development programs till approvals in highly regulated markets.
• At least 10 years of leadership experience leading a development team.
• Strong leadership skills, with experience managing and developing high-performing R&D teams.
• Able to multi-task in a dynamic environment.
• Strong ability to make data-driven decisions and manage complex R&D projects and timelines.
• Organized and able to lead a functional group of R&D.
• Excellent interpersonal and communication skills, both verbal and written, with the ability to effectively collaborate with cross-functional teams and build relationships with key stakeholders.
• Working understanding of GMP and QSR regulations and guidance applicable to the development of products.
• Experience with EMA, FDA, ANVISA, HC and other regulated markets with an understanding of regulatory requirements.
• Proven track record of successful product developments.
• Experience and knowledge across a broad range of different technologies for peptide developments.
• Proven ability to manage multiple projects at a highly scientific operational level.

Why join us?

Exciting Challenges: Every day brings new opportunities to learn and grow.

Supportive Environment: We foster a culture of collaboration, where your ideas are valued, and your voice is heard.

Career Development: We're committed to helping you reach your full potential through ongoing training and development opportunities.

Recognizing Excellence: We recognize and appreciate hard work and dedication by offering competitive compensation packages and employee rewards programs that acknowledge contributions and achievements.

Fun and Inclusive Culture: We believe in celebrating our successes and building strong connections within our team.

Ready to Ignite Your Passion?

If you're ready to take the next step in your career and join a business committed to consistently deliver high-quality products and services, then we want to hear from you Send us your resume today

Please be informed that only selected candidates will be contacted.