Senior Medical Director – Clinical Program Lead, Immuno-Oncology
|Date posted:||18. March 2022|
The Clinical Program Lead is accountable and responsible for development and implementation of global medical development plans for early phase project(s).He/She serves as global clinical program lead on early stage project or at the indication study level for a larger/complex/multi-indication program. The Clinical Program Lead is responsible for designing and conducting a global clinical program resulting in quality regulatory submissions and contributes to the overall strategy in collaboration with relevant other functions within HOOKIPA to the development and execution of the disease area strategy. He /She reports directly to the SVP, Therapeutic Area (TA) immuno-oncology Head.
- Fulfills the role of Clinical Program Lead and is a member of the Project Core Team.
- Responsible for the design of the clinical development plan for their drug, after soliciting appropriate input and review from Clinical Operations colleagues as well as other contributing line functions (Regulatory Affairs, Statistics, Clinical Operations, Commercial and others).
- Leads the clinical team for the design, implementation and execution of clinical trials. Participate in the interpretation of data to support decisions to advance or halt development of a new drug or to support regulatory submissions.
- Responsible for execution and delivery of the clinical development plan and acquires publicly available knowledge of competitor products and clinical plans.
- Motivates and inspires global clinical team towards the common goal of submissions of approvable regulatory filings or next clinical milestone.
- Attend relevant clinical and research scientific conferences, keep abreast of the scientific and medical literature pertaining to the area of clinical development.
- Attends important meetings with the FDA and, as needed, with regulatory agencies worldwide.
- Responsible for keeping Project Core team, other project physicians, Pharmacovigilance Lead, and TA Head informed of clinical progress and any critical clinical and safety issues.
- Contributes to clinical documents: protocols, IBs, DSURs, clinical trial applications, INDs, clinical study reports, statistical analysis plans, publications, CSR and clinical sections of regulatory submissions. Responsible for clinical responses to regulatory agencies.
- Responsible for clinical expert panel meetings and advisory boards to give input on clinical plans.
- Responsible for reviewing Investigator Initiated Study proposals and integrate those studies in the strategy of the general clinical development plan.
- Presents to senior management and external audiences on clinical aspects of compound development: including milestones, strategies, recent data.
- Incorporates Patient-Reported Outcomes endpoints such as Health-Related Quality of Life requirements into protocol design as appropriate.
- Collaborates with Medical Directors across TA and may have oversight of study physician contractors.
- Matrixed relationship to colleagues on the Global Project Team, Clinical Operations, Statistics, Regulatory Affairs, Biomarkers, Clinical Supplies, Clinical Pharmacology and Medical Affairs.
- Collaborates with the other Project Core Leaders to ensure productive functioning of the Global Project Team.
- Reports to the SVP, Therapeutic Area (TA) immuno-oncology Head.
- Medical Degree (MD) and specialization in oncology preferred. Prior experience in clinical development for prostate cancer drugs strongly preferred.
- Additional post doctoral training or additional qualifications such as PhD, MBA, MPH preferred.
- Should have at least 3 years relevant experience in drug development at a biotech/pharmaceutical company or clinical experience at academic clinical research (NCI, NIH, Academic Research groups, etc.) groups
- Prior experience in immuno-oncology drug development (e.g. immunotherapy) strongly preferred.
- Prior experience in leadership role preferred.
- Significant and demonstrable working-knowledge of regulatory procedures and guidelines in all regions (global scope)
- Proven track record in clinical study design, monitoring and execution and results analysis
- Demonstrated knowledge of designing, implementing and conducting clinical studies, to produce both timely and good quality data delivery.
- Experience in development and implementation of global clinical trials for the registration and support of NMEs worldwide preferred.
- Fluent in English, both spoken and written
- Authorized to work in the US
What we offer
- Strong team with dedicated and passionate employees
- State of the art infrastructure
- An excellent working atmosphere
- Opportunities for personal development
- Employee benefits such as health screening, public transportation card, Sodexo pass
- Working in a multinational and multicultural environment
We offer a comprehensive package with competitive salary, paid holidays and sick leave, along with a full range of medical, dental/vision insurance and 401(K) plan. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.
Starting date: June 2022
If you (m/f/d) are interested in this challenging position, please send your CV including a cover letter (summarizing your qualification and experiences) as well as your credentials to: firstname.lastname@example.org
For more information on HOOKIPA please visit www.hookipapharma.com
This position will be recruited through HOOKIPA directly and does not require external support.