Medical Director/Sr. Medical Director« Back
Job #: 02-228
Job Title: Medical Director/Sr. Medical Director
Location: Waltham, MA
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.
We are seeking a Medical Director/Sr. Medical Director to be responsible for providing the clinical expertise to the therapeutic area and will work closely with a cross-functional team to align the clinical development plan with the overall development strategy of the relevant products.
This position will report to the VP, Clinical Development and be located in the Waltham, MA office.
- Serve as the Medical Monitor for clinical trials, to address patient eligibility and treatment questions in cooperation with the contract research organization or directly with study investigator
- Review safety data for routine medical data review, trend review, and safety signals from ongoing trials. Assisting with coding, and data cleaning in collaboration with Clinical Operations
- Providing specific therapeutic area expertise to enhance innovation and efficiency in clinical development
- Collect external data and competitive intelligence in select kinase targets
- Authoring clinical sections in regulatory documents not limited to IND submission and annual updates, study protocols, investigator brochures, briefing documents, and other study-relevant documents such as patient informed consent documents
- Reporting of clinical trials that meet the standards of excellence for ethics, scientific merit, and regulatory compliance
- Writing manuscripts, publications, or other documents intended for external audiences
- Acting as an internal resource for functions requiring clinical input on select drug(s) including primary point of contact for clinical trial staff at study sites for clinical issues as well as regulatory, safety and other functions
- Preparing safety charters, DMC charters, or other specific management plans and manuals in a cross-functional team
- Supporting or preparing data interpretation and clinical trial reports
- Contributing in an active and ongoing manner to the scientific, clinical, and commercial development of current and future product candidates
- Develop and manage relationships with key opinion leaders for clinical programs
- Contributing to Strategic or Clinical Advisory Boards
- Supporting Medical Affairs and Business Development as needed.
- Medical Degree or equivalent, specialization in oncology is desirable
- Minimum of 5 years’ experience in pharmaceutical or biotech industries preferred, or equivalent academic and clinical experience
- Experience with clinical trial design, conduct, and medical monitoring
- Knowledgeable and current in GCP guidelines in US and Europe
- Be well connected within the medical and scientific community and have a proven successful track record
- Outstanding leadership, team, presentation, written and oral skills required
- Hands-on experience with clinical trial strategy, methods and designs
- Collaborative and flexible in personal interactions at all levels of the company
- Ability to work proactively and effectively, with exceptional creative problem- solving skills
- Excellent strategic planning, organizational and communication skills
- Up to 30% travel
- Board certification/eligibility in Oncology is highly desired
- Global clinical research experience and experience interacting with regulatory authorities
Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.