Director Clinical Affairs
A fantastic opportunity has arisen for a Director of Clinical Affairs to lead clinical programs for the assigned compounds. The post holder will be expected to oversee the planning, execution and interpretation of clinical trials results or research activities. You will also be expected to have accountability for oversight and close collaboration of clinical activities.
- Leads clinical program(s) in accordance with the clinical development strategy for the clinical program(s).
- Leads/participates in cross-functional teams providing clinical input on behalf of the clinical team, involved in the interpretation of the clinical results and their communication to internal and external stakeholders.
- Accountable for preparation of the clinical part of briefing books and regulatory documents for the interactions with the Health Authorities (HA), preparation of clinical parts of marketing authorisation dossiers and responses to subsequent questions.
- Provides input to device related clinical questions as ie human factor study protocols.
- Accountable for setting the scope for clinical content of Clinical Study Protocols, Investigator Brochures, Clinical Study Reports, Clinical Modules for submission, including Integrated Summary of Efficacy, together with the safety colleagues for the Integrated Summary of Safety, study plans, and other documents as needed.
- Accountable and responsible for sponsor elements for inspection readiness related to the clinical elements including respective parts of the TMF
- Taking as needed clinical leadership role in meetings with the HA presenting the Company position regarding the clinical programs and the strategy for its achievement.
- Contributes to the data disclosure of clinical trials' results including but not limited to publications.
- Assures high quality input to budget for the clinical areas and manages related activities (ie contracts with consultants , invoices etc).
- Contributes to due diligence activities as required
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research related to his/her work activities.
Skills and Requirements
- Medical Doctor is preferred, alternatively a PhD in a biological area, Vet med .
- At least 5 years for a MD, 7 years for a PhD of clinical development experience in the pharmaceutical industry or CRO preferably in biotechnology in a global role, leading clinical development activities from early stage development to submission and approval by the HA.
- Ability to lead and manage complex clinical program(s)
- Ability to assess risks and provide innovative solutions related to the assigned clinical program(s) and to present risk-benefit assessment to the clinical team and senior management if requested
- Ability to lead cross-functional teams in the matrix model and to motivate by example the other team members with a 'can do' attitude
- Willingness to take accountability, hands on including administrative and operational tasks with an open mindset.
- Ability to work constructively without micromanagement with CROs with a resource efficient mindset.
- Excellent communication skills to represent the organisation during interaction with HA, external stakeholders, including key opinion leaders
- High commitment for achievement the Business unit goals
- Ability to think strategically and drive clinical programs with the right decision-making mindset considering short and long-term impact of his/her decisions.
- Work experience in a multinational environment
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.