Director/Sr. Director, Clinical Development will be a Global Respiratory Therapeutic Area (TA) physician who has the ambition to work across the Discovery and Global clinical development arena, leading several projects from pre-IND through Phase III stage. Sr. Director will lead a group of clinical development physicians in the Global Respiratory TA Franchise, reporting to the Head of Global Respiratory Clinical Development. Sr. Director will be providing medical insights to the Discovery, Business Development, and commercial teams and responsible for clear definition of unmet medical needs in the Respiratory area. Sr. Director is expected to develop, drive and deliver clinical development strategy for assigned projects, as well as design and execute individual clinical development trials, accountable to the Project team and Head of Clinical Development for assigned assets. The successful candidate will have the ability to assess emerging scientific and clinical development advances and assess these for the potential to provide new therapeutic options for patients, through innovative study design.
Serves as a Clinical leader designing clinical development plans and individual clinical studies from Phase 0 to Phase IV. Fully accountable for clinical trial design and leading the clinical sub-team through study execution. Provides medical support and guidance in investigator selection, study initiation and study conduct, patient/subject safety or oversees CRO medical monitor. Reviews safety and efficacy data, leads the study team through analysis and interpretation of the study results, and makes recommendations as to appropriate next steps. Trains and mentors clinical study staff on the clinical aspects of the product and its indications. Leads a team of clinical study physicians also accountable for their respective clinical trials. Responsible for the clinical/medical leadership of INDs, NDAs, BLAs and other global regulatory filings. Provides clinical leadership and expertise in meetings with Health Authorities globally.
Leadership: Ability to implement the clinical vision and strategy. To lead intra- and inter-departmental teams, matrix-manage a cross-functional team with integrity, flexibility and excellent communication skills.
Judgment: evidence of good clinical and scientific judgment. Ability to interpret the significance of preclinical and clinical data, and to anticipate the information that will be needed to satisfy regulatory requirements. Ability to progress projects safely and efficiently. Know when to seek advice from colleagues and senior management.
Teamwork: to build and lead clinical teams and determine what resources and talents are needed for the rapid progression of the project. Interact effectively across boundaries with other functions and disciplines using influencing, communication and relationship building skills. Able to secure, manage and maintain critical partnerships with key business partners.
Collaboration: to form collaborations with key external experts to take world class science and deliver meaningful benefits for patients.
Any other task assigned by a supervisor.
MD degree or equivalent required. Board certification and/or strong experience in clinical development in Pulmonary or Allergy/Immunology therapeutic areas are required. 8+ years of clinical development experience in a pharmaceutical industry are required; proven track record of leading studies from early stage through to regulatory submission. Must speak fluid English.
Demonstrated track record of accomplishments in Pulmonary or Allergy/Immunology therapeutic areas along with experience in the management of patients with asthma/COPD. Proven track record or training (e.g. PhD) in scientific work would be advantageous. Direct management experience is strongly preferred.