Global Clinical Development Lead Infections

Proclinical is seeking to hire a Global Clinical Development Lead Infections located in Munich, Germany for a biotech establishment.

**Responsibilities**:

- Lead the global development team (in liaison with the responsible program manager) for assigned programs, communicating the strategy, and providing clinical and scientific guidance to cross-functional teams (e.g., Regulatory, Pharmacovigilance, Biostatistics, etc.) to meet timely execution of clinical development project deliverables
- Own the strategy formulation and operational planning, content, execution, and delivery for assigned programs and be a key driver of the integrated development, submission, and publication plans
- Coordinate with the VP, Clinical Development to make strategic proposals on company's platforms incl. overall approaches and investments, and to steer clinical strategies and their portfolio and platform operationalization
- Own and steer the definition of the Target Product Profile for assigned programs and translate it into the Clinical Development Plan
- Supervise and lead the design and execution of clinical trials of assigned programs in collaboration with other Clinical Development physicians and functions
- Take ownership together with partner functions in Development on the acceleration of program and trial design and innovation for the patient (e.g., digital endpoints, synthetic control arms, RWE / HEOR, PRO, Medical Affairs)
- Take responsibility for clinical trial medical/safety aspects and risk-benefit assessments supported by the study clinical expert and Medical Safety team. Collaborate closely with Medical Safety / Pharmacovigilance in development of Risk Management Plans.
- Own final program data and reporting to decision-making bodies, senior management, and advisory boards, as applicable
- Represent the program to industry partners, collaborators, health authorities and trial site investigators and administrators
- Take accountability for and guide preparation of clinical sections of key documents, including Investigator's Brochures, IND submissions, CTAs, and NDAs. Respond to questions from regulatory authorities, IRBs, and ethics committees

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**Skills and Requirements**:

- MD or MD-PhD with strong scientific and clinical background in infectious diseases. Board certification in infectious diseases, internal medicine, and/or pediatrics and vaccine clinical development experience are a plus
- Minimum 5 years of experience in early
- to late-stage infectious disease vaccine or therapeutic development in an industry setting. Demonstrated ability to:

- Plan and conduct clinical trials from exploratory Phase I/II clinical studies through late-stage development in Phase III and NDA/BLA submission
- Deliver high-quality results within defined deadlines
- Lead cross-functional teams and workflows (Pharmacovigilance, Biostatistics, Clinical Operations, and Regulatory Affairs)
- Demonstrated experience as a Development Lead for a program is a plus
- Comprehensive understanding of FDA, EMA, ICH and GCP guidelines. Prior interaction with FDA and EMA regulatory agencies is desirable
- Demonstrated leadership experience and several years (7+ years) of line management experience in a global matrix organization
- Ability to lead horizontally and drive execution of workplans in collaboration with other functions, without having formal line management authority
- Strong interpersonal skills in addition to exceptional written and oral communication skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions
- Proficiency in English (written and spoken)

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Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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