JOIN OUR TEAM
Werewolf Therapeutics is an exciting start-up biotech, located in the heart of Cambridge MA, focusing on the development of novel biologic agents for the treatment of cancer.
We are searching for a (Senior) Medical Director to join the ‘pack’. This position can be fully remote and will be the first key hire in clinical development reporting to the Chief Medical Officer.
Werewolf Therapeutics, Inc. is an innovative biopharmaceutical company pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of cancer. We are leveraging our proprietary PREDATOR™ platform to design conditionally activated molecules that stimulate both adaptive and innate immunity with the goal of addressing the limitations of conventional proinflammatory immune therapies. Our INDUKINE™ molecules are intended to remain inactive in peripheral tissue yet activate selectively in the tumor microenvironment. Our most advanced product candidates, WTX-124 and WTX-330, are systemically delivered, conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) INDUKINE molecules, respectively, for the treatment of solid tumors. We are continuing preclinical studies for both WTX-124 and WTX-330 and expect to advance each candidate in multiple tumor types as a single agent and in combination with an immune checkpoint inhibitor.
Cancer immunotherapy targeting immune checkpoints is demonstrating transformative anti-tumor activity in clinical use, and additional immune regulatory pathways are emerging with the expectation that therapeutics targeting these pathways will rapidly enter clinical development.
The (Senior) Medical Director will provide strategic medical guidance for and lead the development of experimental immunotherapy agents in the Werewolf portfolio, beginning with the selection of a development candidate in collaboration with research colleagues and continuing through clinical proof-of-concept and potentially full development.
- Provides strategic medical guidance for the development of new immune-oncology agents starting in preclinical development.
- The (Senior) Medical Director is specifically responsible for creating a clinical development strategy for new agents entering development. The development strategy combines the (Senior) Medical Director’s medical knowledge with the expertise of colleagues in a wide range of other disciplines (e.g., Clinical Operations, Biomarkers, Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy.
- Must provide an early clinical development strategy that foresees and supports subsequent registration trials.
- The (Senior) Medical Director integrates preclinical information (pharmacology, toxicology, pharmacokinetics) and interprets its implications for clinical development, as articulated in the Investigator’s Brochure and first-in-human protocol.
- The (Senior) Medical Director collaborates with Clinical Operations colleagues and third-party vendors to develop clinical protocols and to develop the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports).
- The (Senior) Medical Director applies his or her medical knowledge to guide the safe, ethical and efficient conduct of the trials under his or her responsibility. He or she is knowledgeable in Good Clinical Practice guidelines and Werewolf Standard Operating Procedures and strives to maintain compliance with them.
- The (Senior) Medical Director liaises with outside experts, investigators, and regulatory authorities in the field of oncology, and represents his or her projects to those groups and authorities.
- The (Senior) Medical Director writes and reviews abstracts/manuscripts, etc. for presentation/publications at internal/external meetings.
- The (Senior) Medical Director participates in various internal and external meetings, as required, to contribute to cross-functional collaboration, report on ongoing clinical activities, and support management objectives.
- MD or MD/PhD degree required.
- Board-certification in an oncology specialty is preferred.
- Proficiency in English.
- Needs 3+ years pharma/biotech industry experience in oncology clinical trials (early oncology development would be preferred) or the equivalent term experience in the academic setting. In case of no industry experience, substantially longer academic experience in translational oncology or hematology and substantial clinical study experience.
- Must have facility with the interpretation of preclinical data in oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology).
- Working knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials.
- Proven ability to analyze and interpret efficacy and safety data relating to oncology.
- Knowledge of GCP and world-wide regulatory requirements relating to clinical trials and oncology.
- Excellent medical/scientific writing skills.
- Effective written and oral communication skills.
- Proven ability to manage and develop a team.
- Excellent personal ethical integrity and a commitment to improving the outcomes for patients with cancer.
For further information or to be considered for this position, please contact: email@example.com