Description 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.
