We are building a high‑caliber drug development consulting group to partner with biotech and pharma sponsors on integrated product development plans, global regulatory strategy, clinical protocol and development design, CMC, clinical pharmacology, nonclinical strategy, and biostatistics. The role blends client advisory, hands‑on plan authorship, and cross‑functional program leadership modeled on best‑in‑class life‑sciences consulting practices.
Key responsibilities:
• Lead client engagements to interpret pre-clinical PK/PD and ADME and to develop clinical pharmacology plans including dose selection and escalation, often as part of a global development strategy from preclinical through approval and lifecycle management.
• Draft and defend clinical pharmacology strategy, including contributions to regulaltory strategy documents, briefing packages, IND/CTA/MAA/NDAs, and responses to authorities.
• Design clinical pharmacology programs and contribute to protocols that align statistical, PK/PD, safety, and operational considerations.
• Provide clinical pharmacology and nonclinical translation advice to optimize first‑in‑human and dose‑selection strategies.
• Mentor junior consultants, build client relationships, and contribute to business development and thought leadership—delivering high‑impact, evidence‑based recommendations consistent with leading consulting firms’ client delivery models.
Qualifications:
• Advanced degree (MD, PharmD, PhD) with 12+ years of drug development and clinical pharmacology or pharmacokinetics experience across multiple therapeutic areas; consulting experience preferred.
• Demonstrated success directing clinical pharmacology programs
• Excellent written and oral communication skills; experience presenting to executive teams and regulatory agencies.
• Ability to travel and lead multi‑disciplinary, cross‑geography teams.
• Experience working in or with top life‑science consultancies or CROs is highly desirable.
Specific subject matter expertise: We seek candidates with deep expertise in the following areas.
- Clinical Pharmacology: PK/PD modeling; dose selection; exposure‑response analyses; DDI strategy
- Global Regulatory submissions: IND/CTA/MAA/NDA/BLAs
- Clinical Development Design: adaptive trials; seamless phase designs; pediatric and rare disease programs.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.
About UsNovotech is a global full-service clinical Contract Research Organization (CRO).
At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
At Novotech you will work alongside empowered teams with a shared commitment to success.
- Strategic vs transactional mindset.
- Ability to gain insights and make proactive decisions quickly.
- Culture that fosters partnership and collaboration, where every voice is heard and valued.
- Ongoing support from senior stakeholders and leadership team.
