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Associate Director, Medical Monitor

Company: Deciphera Pharmaceuticals
Location: Waltham
Posted on: September 12, 2020

Job Description:

Clinical Development & Operations – Clinical Development /

Deciphera Pharmaceuticals is a commercial biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates in clinical studies, QINLOCK is Deciphera’s first FDA-approved drug, a switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK, an oral oncolytic, is also approved in Canada and Australia for the treatment of fourth-line GIST.

Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas.

We offer an outstanding culture and opportunity for personal and professional growth based on our “PATHS” Core Values:

- Patients – places the importance of improving the lives of patients and their caregivers at the forefront of every day’s work.

- Accountability – for our performance and the way we work with coworkers and other stakeholders.

- Transparency – in our intent and actions to both internal and external stakeholders.

- Honesty and Integrity – fosters trust and strives to deliver on our and the company’s promises.

- Stewardship – values and uses wisely the resources and investments provided to the company.

Our Science and Our Pipeline:

Deciphera is developing novel small molecule drug candidates to improve the lives of cancer patients by addressing key mechanisms of tumor and drug resistance that limit the effectiveness of many cancer therapies. Our pipeline of drug candidates is designed to stop cancers from growing and spreading by inhibiting mutant forms or over expression of a family of enzymes called kinase. Enabled by our proprietary kinase switch control inhibitor drug discovery platform, we have developed kinase switch control inhibitors that interact at a molecular level in a way that is distinct from other kinase inhibitors and are designed to generate higher and more durable rates of response.

We have developed a diverse pipeline of differentiated, wholly owned, orally administered, oncology drug candidates that includes, among others, our recently approved product, QINLOCK (ripretinib), a broad-spectrum KIT and PDGFRa kinase switch control inhibitor is approved for the treatment of fourth-line GIST. Our follow-on study of ripretinib, the INTRIGUE study, is a pivotal Phase 3 trial in second-line GIST. We also have two additional clinical-stage programs for drug candidates DCC-3014 and rebastinib, both immune-oncology (or immunokinase) inhibitors, targeting the kinases CSF1R and TIE2 respectively. Two research-stage programs are in the pipeline as well.

Position Summary:

We are seeking an Associate 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 Senior Medical Director, Clinical Development and be located in the Waltham, MA office.

Key Responsibilities Serve as the Medical Monitor for Phase 1-3 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.

Required Qualifications MD, PA, NP 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

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

Preferred Qualifications Global clinical research experience and experience interacting with regulatory authorities

Keywords: Deciphera Pharmaceuticals, Waltham , Associate Director, Medical Monitor, Other , Waltham, Massachusetts

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