Global Bbu Medical Development Director

Vor 4 Tagen

Baar, Schweiz Biogen Vollzeit

Job Description

As Global Biosimilars Business Unit(BBU) Medical Development Director you will be responsible for providing clinical and medical guidance for clinical deliverables in the assigned biosimilar program and for directing innovative global clinical development strategy. As a SME in clinical development you contribute to the clinical regulatory strategy development. You provide medical/clinical expertise for the regulatory submission effort and clinical development process, contribute to and/or prepare clinical development plans, represent company with the domestic and international regulatory authorities, contractors and corporate partners. Here you provide expertise for various departments, projects, business case development and teams/committees.

This role is based in Baar, Switzerland and you will be a member of Biogen Biosimilars RnD leadership team.

**What we offer**:
**What you'll do**:

- Provide clinical and medical input for all clinical deliverables in the assigned program
- Provide medical expertise, contribute to and/or prepare Clinical Development Plans and clinical study related documents, including, but not limited to, Investigator Brochure, Clinical Study Protocol, Development Safety Update Reports, communication with regulatory authorities, Clinical Study Report, with the support of other R&D functions.
- Leading development and execution of clinical sections of development trial and clinically relevant regulatory documents in partnership with other functional leads (Drug Safety, Clinical Operations, Biostatistics and Regulatory Affairs)
- Share with Clinical Operations a responsibility of clinical study oversight, management of CRO and other key service providers, and ensure the efficient, safe, ethical, and high-quality conduct of clinical studies
- Contribute to medical monitoring to ensure data integrity and coherence of data interpretation under the guidance of Target Product Profile and Clinical Devolvement plan
- Contribute to strategic plans and objectives
- Proactively and reactively inform, as appropriate and required, Drug Safety, Global Project Team, Clinical Study Team and functional legally leads of any safety signals emerging from clinical studies - Any emerging medical risks and opportunities with an impact on timely and successful completion of Clinical Development Plan
- Contribute to corporate scientific communication (abstracts, articles, presentations for internal and external purposes)
- Ensures compliance with GCP, ethical, scientific, and medical guidelines, and statutory principles throughout all clinical development activities.
- Make final decisions on clinical and medical matters, supporting clinical operations to achieve clinical team objectives and execution of the clinical programs
- Partners and interacts with internal and external stakeholders (KOLs, investigators, leveraging key communication skills and clinical expertise). Establish and maintain professional relationships with external medical experts and key thought leaders, and represent company at investigator meetings, expert panels, advisory boards or alike.
- Support the Project Team in all medical, scientific, and clinical matters during study conduct
- Work on complex issues where analysis of situations or data requires an in-depth knowledge of the therapeutic area
- Ensure budgets and schedules meet corporate requirements

Qualifications
- MD strongly preferred.
- PhD and MBA or equivalent are plus

**Experience and Essential Skills**:

- 10+ years pharmaceutical experience; biosimilar experience preferred
- 5+ years experience in senior functions with a decision making authority
- Proven track in leading clinical development
- Immunology clinical or drug development is a plus
- Experience is supporting filing and regulatory submissions
- Good understanding of GCP/ stats background / registrational study designs
- Biosimilars experience (desired)
- Experience in European and the US clinical development pathways
- Comply with company SOPs, GCP, governmental policies, regulations, statutory guidelines and applicable laws regulating drug development and clinical research
- Develop and maintain state-of-the-art scientific, medical, and managerial knowledge by establishing and maintaining an external professional network, reading pertinent scientific and medical publications, attending pertinent training courses, workshops ,conferences etc.
- Foster effective, positive interactions with the expert bodies of various nature and corporate partners.
- Experience in interpretation of clinical requirements, regulations, guidelines, policy statements, etc.
- Ability to lead and influence project teams, committees, etc. to attain group goals.
- Demonstrate excellent leadership and communication skills.
- Ability to represent the department in senior internal forums, committees and external meetings.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel beyo

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