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 define global development strategy from preclinical through approval and lifecycle management. • Draft and defend regulatory strategy documents, briefing packages, IND/CTA/MAA/NDAs, and responses to authorities. • Design clinical development programs and protocols that align statistical, PK/PD, safety, and operational considerations. • Oversee CMC strategy and dossier planning to ensure alignment with clinical timelines and regulatory expectations. • Provide clinical pharmacology and nonclinical translation advice to optimize first ‑ in ‑ human and dose ‑ selection strategies. • Supervise biostatistical planning, SAPs, and interpretation of efficacy/safety analyses. • 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 B. Qualifications • Advanced degree (MD, PharmD, PhD) with 10 years of drug development experience across multiple therapeutic areas; consulting experience preferred. • Demonstrated success leading global regulatory interactions and submissions across major regions. • Strong track record in clinical protocol design, statistical planning, CMC strategy, and clinical pharmacology integration. • 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 C. Specific subject matter expertise We seek candidates with deep expertise in one or more of the following areas. Please indicate level of experience and representative projects in your application. • Global Regulatory Strategy: IND/CTA/MAA/NDA/BLAs; regulatory intelligence; accelerated pathways. • Clinical Development Design: adaptive trials; seamless phase designs; pediatric and rare disease programs. • Biostatistics: SAPs; adaptive design simulations; Bayesian methods; multiplicity control. • Clinical Pharmacology: PK/PD modeling; dose selection; exposure ‑ response analyses; DDI strategy. • CMC: formulation development, comparability, stability strategy, post ‑ approval change management. • Nonclinical: toxicology package design; translational safety assessment; species selection and bridging strategies. • Health Authority Interactions: pre ‑ IND/Scientific Advice/Type A/B/C meetings and dispute resolution. 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.
