HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T cells to address unmet needs in cancer.
This leveraging its proprietary, versatile platform to engineer a broad pipeline of differentiated arenaviral therapeutics. These novel immunotherapies induce robust antigen-specific killer T cells to a broad range of self and non-self antigens, including viral antigens, tumor-associated antigens and neoantigens. HOOKIPA’s platform technology uses replicating viral vectors based on the target cancer, with the potential to induce killer T cell response levels previously not achieved by other immunotherapy approaches.
HOOKIPA’s pipeline includes wholly-owned investigational arenaviral immunotherapeutics targeting HPV16+ cancers, prostate cancer, KRAS-mutated cancers (including colorectal, pancreatic and lung), and other undisclosed projects. In addition, the company aims to develop functional cures of HBV and HIV in collaboration with Gilead.
The Head, Immuno-Oncology Clinical Development will be responsible for managing the clinical development programs focusing on immuno-oncology product registrations world-wide. This leader will oversee ongoing and planned clinical trials, as well as the exploration of novel indications. They will provide clinical leadership to cross-functional project teams on development strategies, clinical study outlines and data interpretation of study results.
This leader will interface with multiple cross-functional areas including clinical operations, medical and scientific communications, commercial (marketing, sales, managed markets), regulatory affairs and safety, as well as external partners and Key Opinion Leaders.
- Provide the direction and vision to HOOKIPA’s immuno-oncology portfolio strategy and lead multidisciplinary clinical teams that drive early to late-stage clinical programs for multiple indications.
- Develop, implement, and execute aggressive and innovative immuno-oncology strategies, while ensuring that development programs effectively advance across all phases of development through registration.
- Provide a high level of oncology medical expertise and direction to drive the immuno-oncology business strategy and decision-making processes.
- Maintain an overview of clinical program status and issues and proactively communicate progress, risks, issues or changes that may impact quality, timelines and/or budget to executive management.
- Provide clinical input during the development and execution of clinical trials focusing on post proof of concept studies.
- Work closely with external KOLs regarding exploration of novel indications, development plans and study outlines.
- Prepare and review regulatory documents including: IND annual reports, IND safety reports, investigator brochures, and development plans; and defend the clinical development program before regulatory authorities.
- Provide clinical oversight for external trial committees, including Investigator meetings, Steering Committees, DSMBs, and advisory Boards, and provide leadership in the collection, analysis and interpretations of clinical data for internal review.
- Sustain and foster a culture and environment of creativity and innovation that will lead to new immuno-oncology medicines.
Qualifications & Skills:
- M.D. from a U.S. accredited institution preferred. U.S. Board Certified or Board Eligible (Oncology desired). At least seven years of drug clinical development experience within the biotech/pharmaceutical industry or equivalent is required
- Proven clinical development strategist with experience designing, implementing and conducting clinical trials
- Late stage development experience, filing and registration strongly preferred.
- Experience with immune-oncology strongly preferred
- Strong knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US and EU
- Previous medical monitoring experience
- Ability to plan, develop, and execute early clinical development studies including selection of relevant biomarkers, pharmacodynamics endpoints, etc.
- Ability to think critically, and demonstrated troubleshooting and problem solving skills
- Demonstrates outstanding management and leadership skills; strong interpersonal skills with ability to confront issues while maintaining collegial atmosphere
- Excellent verbal, written and presentation communication skills required. Must have strong interpersonal skills with the ability to work collaboratively in a cross functional manner independently
- Strong productivity/organizing/planning skills with the ability to span a breadth of topics from the highly detailed to the conceptual
- Demonstrates integrity and ethics
- Complies with all applicable policies regarding safety, GCP and environmental policies
- Ability to travel approximately 25% [domestic and international]
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: as soon as possible