I’m excited to be partnering a growing, privately owned biotechnology company in the Cambridge/Boston area who are developing a pipeline of specialist cancer therapeutics and are one of the leaders in their field. They are preparing to enter the clinic with their lead, first-in-class asset therefore are now establishing their clinical team on a permanent basis. In addition to their lead asset at IND-stage, they have an array of multiple other pre-clinical and discovery stage programs dedicated to improving the lives of patients with cancer.
The company is led by a highly successful CEO (Ph.D.) with over 20 years of experience in leadership functions and vast knowledge of building biotechnology companies. One of their core strengths is scaling companies up from pre-clinical phase to fully functional clinical development organisations having done so numerous times, as well as initiating strategic partnerships with key players in the pharmaceutical industry.
We are searching for a scientifically focused M.D who needs to understand and resolve the science of their targets/drug candidates and then conduct clinical development based around that. This person will be a key member of the company’s management team and work closely with the CEO, CSO and the executive team to shape the clinical development strategy on a product-by-product basis.
- Develop and oversee the execution of the clinical development plan for one or more of the pipeline drug candidates
- Build and lead, or work closely with the company’s molecular diagnostic group in order to develop the pipeline drug candidates as precision medicines targeted to selected patients with cancer.
- Lead the establishment of a relevant development plan and patient selection strategy based on a thorough understanding of the lead drug candidate’s target in cancer, and the drug candidate’s mechanism-of-action.
- Design and generate clinical trial protocols consistent with the development plan, patient selection strategy, and the particular stage of development for the lead drug candidate.
- Utilize their extensive U.S. and international network to identify and recruit principal and participating investigators, consistent with the stage of development for the lead drug candidate.
- Lead the execution of clinical trials by working closely with regulatory and clinical operations team to achieve necessary filings with relevant regulatory authorities and select/secure the services of top quality CROs.
- Evaluate trial data including clinical activity, safety, PK and PD in a manner leading to next-step development decisions.
- Generate and present clinical data to key stakeholders, including the company’s Board of advisors and directors, investors, and meetings of principle and participating investigators.
- Represent the company externally in scientific conferences, presentations, and industry and investment groups. Build and maintain solid working relationships with key opinion leaders, and leading clinical investigators in the oncology field. Establish and foster partnerships with the international scientific and medical community.
- An MD or MD/PhD in the field of oncology is essential for the role.
- A scientifically-minded and data-driven clinical drug developer with significant expertise in the precision oncology therapeutics area. Possessing the desire to engage with an innovative, highly-differentiated technology platform.
- Mastery and thorough knowledge of, extensive experience and demonstrated track record with employing molecular diagnostic tools for the precision development of oncology drug candidates.
- Broad exposure to, and experience with the full range of preclinical and clinical stages of oncology product development, particularly in the transition from preclinical to clinical stage is key. Specific experience in biomarker strategy, patient stratification, IND-enabling studies, and clinical operations would all represent relevant skillsets.
- Credibility within the international medical and scientific community. Solid personal and professional relationships with key opinion leaders in the oncology field is desirable.
- Excellent interpersonal, communication and presentation skills with ability to relate both to internal and external stakeholders. Ability to develop strong positive relationship with senior management, Board of Directors and investors. This includes having the ability to execute and communicate effectively with team members located across multiple locations.
This is a great opportunity to join a company in a promising area in the oncology space. Backed by a strong investment syndicate and a well experienced management team, this is a great opportunity for folks with oncology clinical development experience.
For more information, contact me as soon a possible via email@example.com