Prestige Scientific

Retained - Senior/Executive Medical Director - Oncology

Prestige Scientific - Cambridge, MA

This is a great opportunity to join a passionately driven group that is changing the way immunoconjugate therapies work by leveraging their patented platform to create precisely targeted and highly tailored drugs that radically improve cancer patients’ lives. The company is using their highly differentiated ADC Platforms to create a pipeline of clinically meaningful candidates

The senior management team possess an extremely impressive track record and a strong commitment to scientific excellence and patient care.

They have cultivated a collaborative workplace and a shared passion to advance therapies that make a significant difference in the lives of cancer patients and their families.

Business Highlights and Upcoming Milestones:

  • Phase 1 study of lead compound, a novel NAPi2v-targeting ADC in patients with solid tumors has reached proof of concept!
  • Initiating a combination study of lead program with 4 different single agents for both NSCLC and Ovarian cancer patients. Dosed first patient in May.
  • Second clinical candidate, targeting NaPi2b, remains on track to enter the clinic in the second quarter of 2020
  • Site selection completed (from 7 sites to 25).
  • 2 IND Filings in 2020 completed and 2 IND planned for 2021.
  • Planning to disclose next clinical candidate in 4Q 2019.
  • Looking to further to expand its patent portfolio to treat broader populations of cancer patients
  • The company continues to advance their strategic collaborations and partnerships with leading pharmaceutical and biotech companies

This Physician will have the opportunity to drive a high-profile clinical program(s) as they continue to progress to expand their lead program with 4 different arms in both NSCL and Ovarian Cancer patients.

This hire will be getting in early enough in this early stage pioneer to help create the clinical development strategy by shaping how the company will perceive, peruse and operationalize clinical studies. Responsibilities to include building and executing on the clinical development plans including design, implementation, analysis, and reporting of clinical studies. This hire will also have an opportunity to collaborate with the program team in developing the long-range strategic plans for programs and working closely with cross functional teams. This position involves both high level strategic planning as well as hands-on responsibilities, medical oversight to support the growing pipeline.

Strategic Leadership Objectives:

  • Shape the clinical development process to address with a commitment to putting patients first.
  • Work closely/lead the Clinical Development team supporting the CMO in the creation and execution of global clinical development plans and studies
  • Represent high value program(s) to Senior Management
  • Key contributor to the continuous development of a corporate environment that is thoughtful about strategy and tactics, culturally intellectual and energetic.
  • External Collaborations/Partners

     

    Clinical Development Objectives:

  • Build and drive clinical development plans for lead program in a randomized phase 1 extension study.
  • Ensure timely initiation, execution and reporting of US/Global clinical trials

Personal Growth:

  • This organization continues to grow and in-turn this will open up more and more leadership opportunities. This hire will work closely with the company’s CMO, dedicated to mentoring and sharing in overall strategic planning for clinical and pre-clinical assets.
  • Opportunity to advance assets to
  • No organizational blocks for someone in this role that wants to move ahead

Responsibilities:

The Medical Director will act as the primary lead for clinical trials (Pre-clinical and Phase 1b), working with cross-functional study teams on clinical trial strategy, design and execution. Key responsibilities include:

  • Accountability for the strategic planning and execution (including study design, method selection, etc.) of Phase I through pivotal studies.
  • Leading efforts to identify, build relationships and communicate with key investigators and trial sites to ensure successful enrollment of the right patients and number of patients.
  • Analyze and interpret data expertly, and clearly communicate results both internally and externally.
    • Acting as primary Medical Monitor, monitoring the safety of enrolled subjects on assigned trials.
    • Participating in the development of Study Protocols, IBs, Clinical Development Plans and other key study documents with minimal guidance.
    • Participating in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
    • Providing scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR).
  • Acts as liaison between Clinical Development and other internal groups (e.g., Regulatory Affairs, Clinical Operations, Clinical Data Management) for assigned studies. Working collaboratively with Medical Team, Clinical Operations, Translational Medicine, and Regulatory Affairs.
  • Working with US and EU regulators

Competency Expectations:

  • Clinical development experience within oncology
  • Proven leadership, strong interpersonal skills and the ability to communicate effectively to scientific and non-scientific groups is required
  • Ideally have past work experience in mid clinical stage development including Phase, II, III trials and evidence of having played a significant part in the preparation of regulatory submissions
  • Solid experience in medical research including experience in the conduct of global clinical trials
  • Experience interpreting clinical data and generation of supporting regulatory submissions of clinical study documents
  • Proven track record of delivery of experimental or novel studies
  • High integrity, get-it-done-roll-up-your-sleeves attitude and committed to putting patients first.
  • Experience working effectively in a fast-paced, team-based environment
  • Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions
  • Strong verbal communication and technical writing skills
  • Confidence in presenting at internal and external strategy meetings
  • Project management skills and focus on delivering results.

Company Overview:

Located in MA. This publicly-held biotechnology company has a unique and proprietary platform for immunoconjugate therapies allowing them to advance beyond the limitations of other antibody drug conjugate approaches. They have four differentiated, proprietary ADC platforms.

Their technologies enable them to design ADC’s with improved efficacy, safety and tolerability to target tumors with greater therapeutic payloads.

The company is advancing their proprietary pipeline through early clinical development and is leveraging partnerships with leaders in the field to accelerate the development of important medicines created with this platform.

 

The company recently announced encouraging results with early signs of efficacy coupled with a favorable safety and tolerability profile and promising treatment duration for their lead program.They are currently enrolling patients in their dose expansion phase of the study focusing on platinum-resistant ovarian cancer and NSCLS adenocarcinoma patient populations.

With these positive trial results and advances in the clinic the company is increasingly more confident that their platform has the potential to effectively treat a variety of cancers.

Corporate Facts and Culture:

  • 85+ person publicly traded company
  • Committed and dedicated to team members’ personal and professional development
  • Very strong and unified senior management team.
  • Transformative stage company, quickly moving from discovery to clinical
  • Open environment, including C-Suite
  • Dog friendly office, bring your dog to work!
  • Everyone has a voice and will be seen and heard from
  • Industry leader in their therapeutic area

Contact Information:

Prestige Scientific is an executive search firm that advises our clients on recruiting impactful leaders.

We provide our clients with a performance-based hiring system that identifies leaders with past success meeting similar corporate objectives as their own, while overcoming challenges and adhering to critical timelines.http://prestigescientific.com/

Tricia Krzywicki

Director, Prestige Scientific

409 Fortune Blvd, Milford, MA 01757

Direct +1 (508) 469-1113

Mobile +1 (617) 650-696

triciak@prestigescientific.com

Assistant: Alison Corshia

acorshia@prestigescientific.com

 



Posted On: Thursday, May 14, 2020



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