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Clinical Development Lead

Alvotech

Singapore

Hybrid

SGD 100,000 - 140,000

Full time

2 days ago
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Job summary

Alvotech seeks a Clinical Development Lead to drive strategic Clinical Development Plans for clinical programs. This pivotal role will ensure scientific input into clinical and regulatory documents while collaborating with internal and external stakeholders. Ideal candidates will have a strong educational background and extensive industry experience, along with the ability to lead and manage complex projects effectively.

Benefits

Good work-life balance
Home office equipment
Global opportunities for advancement
Positive and innovative work environment

Qualifications

  • Minimum of 5 years in relevant pharmaceutical roles.
  • Strong background in pharmacology, immunology, or oncology pref.
  • Fluent in English, additional languages are a plus.

Responsibilities

  • Lead preparation and review of clinical documents.
  • Ensure scientific excellence in clinical development strategy.
  • Interpret clinical trial data and engage with regulatory authorities.

Skills

Project Management
Critical Thinking
Analytical Skills
Leadership Skills
Negotiation Skills
Risk Assessment
Stakeholder Management

Education

Masters in Life Sciences
M.D., Pharm.D., or Ph.D. (preferred)

Tools

Microsoft Office
Veeva Vault

Job description

    Alvotech is looking to hire a Clinical Development Lead who will play a pivotal role in the strategic planning and preparation of Clinical Development Plans (CDP) for assigned clinical programs. As a clinical expert, this role supports Clinical and Medical Affairs Group in interactions with external stakeholders such as regulatory authorities, key opinion leaders, data monitoring boards, and advisory boards, as well as internal stakeholders including CMA, GRA, and Device Development.The Clinical Development Lead is responsible for ensuring state-of-the-art scientific input into all relevant clinical and regulatory documents for assigned projects. Additionally, this role involves thorough review, interpretation, and presentation of clinical trial data for further discussions, both internally and externally, in collaboration with Medical Leads.This position is based in Bangalore, India, with the possibility of a hybrid or remote work setting. The role also requires international travel to support assigned activities.Scope & Responsibilities: Lead preparation and review of clinical documents (protocol synopses, protocols, clinical trial reports, IMPD sections, IB). Ensure scientific excellence in clinical development strategy, trial designs, and regulatory documents. Lead the preparation of Clinical Development Plans (CDP). Provide high-level scientific input for safety reports, briefing documents, INDs, NDAs, and other regulatory submissions. Offer clinical/scientific input during clinical trial development and execution, including data review activities. Contribute to study documents (e.g. SAP, DMP). Interpret clinical trial data. Lead interactions with regulatory authorities for clinical development discussions. Participate in or provide input for independent monitoring committee meetings. Maintain up-to-date training records. Stay current with ICH-GCP requirements.Job Requirements: Education: Minimum Masters degree in life sciences or equivalent. M.D., Pharm.D., Ph.D. strongly desired. Experience: 5+ years in relevant roles within the Pharmaceutical Industry. Scientific Background: Strong background in pharmacology, immunology and/or oncology preferred. Biosimilars/Biologicals Experience: Prior experience with biosimilars or biologicals essential. Language Skills: Fluent in English (written and verbal). Additional languages are a plus. Leadership and Interpersonal Skills: Strong leadership, participation, and team contribution skills, with the ability to build team spirit, communicate openly, and share knowledge. GCP Knowledge: Deep understanding of GCP and GxP. Technical Skills: Proficient with Microsoft Office (Word, Visio, Excel, PowerPoint).________________________What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change people's lives. The chance to be part of a global and fast-growing company. An international work culture that encourages diversity, collaboration, and inclusion. Positive, flexible, and innovative work environment. A clear and developed organizational structure. Training and global opportunities to advance. A good work-life balance. Home internet and home office equipment.Why AlvotechAt Alvotech, we are passionate about improving lives by increasing access to affordable biologics. Were purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agileenvironment.True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Lets create a healthier world together, through affordable biologic medicines.,

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