Executive Medical Director
- Cambridge, MA
Executive Medical Director
This is a great opportunity to join a passionately driven group that is focused on developing targeted and immuno-oncology therapeutics. Their most advanced clinical candidate is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, a Wnt pathway modulator. Their lead program is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers.
Their second clinical candidate is a humanized GITR agonist monoclonal antibody designed to enhance the immune system's anti-tumor response that is in advanced solid tumor studies.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:
- Entered into an exclusive option and license agreement with a global partner for the clinical development and commercialization of anti-Dickkopf-1 (DKK1) antibody, in Asia (excluding Japan), Australia, and New Zealand
- Completed a $27 million equity financing with the global partner, a VC and a lead institutional investor
- Presented final data from its Phase 1/2 clinical trial plus Keytruda® (pembrolizumab) in patients with advanced or recurrent esophagogastric cancer at the American Society of Clinical Oncology 2020 Gastrointestinal Cancers Symposium
- Presented updated data from its Phase 2 clinical trial as monotherapy and in combination with paclitaxel chemotherapy in patients with advanced gynecological malignancies at the 2019 International Gynecologic Cancer Society Annual Global Meeting and at the Society of Gynecologic Oncology 50th Annual Meeting on Women's Cancer
- Announced investigator-initiated study in patients with DKK1+ advanced prostate cancer
- Announced investigator-initiated study plus Opdivo® (nivolumab) in patients with advanced biliary tract cancer that is partially supported by Bristol-Myers Squibb
- Announced investigator-initiated study plus Tecentriq® (atezolizumab) in patients with advanced esophagogastric cancer that is funded by Roche.
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 registrational studies for lead program.
- Ensure timely initiation, execution and reporting of US/Global clinical trials
- 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 registrational studies
- No organizational blocks for someone in this role that wants to move ahead
The position will involve clinical trial development with novel anti-cancer therapies. The Medical Sr./Director will act as a clinical representative to a number of cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within one or more programs. They will also participate in review of the safety database/serious adverse events and assist in developing the safety/risk management plans and long-range strategic plans for the molecule or molecules.
Serve as content owner for assigned clinical trial and other documents where clinical/medical is identified as the content owner
- Conduct protocol development to include working closely with medical writing and project teams.
- Write the clinical sections and review of all clinical documents related to the assigned clinical studies (e.g., study protocols and study reports), as well as contributing to related study documents, e.g., Investigator Brochure
- Provide medical/scientific input and driving/contributing to the creation of these documents, or parts thereof
- Collaborate with other contributors to these documents to ensure overall consistency and quality
- Participate in program development, including working cross-functionally with all of the disciplines necessary for successful drug development: pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, marketing, legal, biostatistics and data management, pharmacovigilence, and clinical operations.
- Interact closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies and comprehending biomarker exploration.
Act as global medical/safety monitor for assigned clinical trials
- Oversee all medical/scientific/safety aspects of assigned clinical trials, including identifying study sites, reviewing of eligibility data, reviewing patient profiles (safety and efficacy) on an ongoing basis, reviewing query generation, working closely with global Clin Ops, Data Management, Medical Writing, etc.
- Direct protocol implementation, including site identification and communication, attend investigators’ meetings, correspond with sites including IRBs, and interact with operations teams.
- Collaborate with global team members (e.g., Clin Ops, PVG, Stats, Data Management, Medical Writing, etc.) on trial execution
- Provide medical expertise in the development, review and approval of Case Report Form (CRF) design, Informed Consent Form (ICF) design, site source documents, etc.
- Review and approve Statistical Analysis Plans (SAPs) and all tables/plots, prepared or designed by Department of Biostatistics for clinical statistical analysis;
- Review the listing and narrative summaries for regulatory submissions including annual reports for NDAs and INDs, and integrated safety summaries.
- Prepare and review of ad hoc documents required in response to requests from the FDA and other regulatory agencies.
- Interact closely with the regulatory department and regulatory agencies, taking part in IND submissions, IB authorship, and communication with US and international regulatory agencies. o Prepare, review, and approve the clinical study and safety related portion for INDs, NDAs (such as Sections 2.7 and 2.5 for NDAs), ANDAs or their amendments or supplements;
- Prepare, review, and approve product labels and packaging inserts for NDA submissions.
- Provide medical expertise in the review of adverse events (AEs) and manage pharmacovigilance activities;
- 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, Pivotal 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.
- 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
- Everyone has a voice and will be seen and heard from
Director, Prestige Scientific
409 Fortune Blvd. Suite 202, Milford MA., 01757
Direct +1 (508) 469-1113
Mobile +1 (617) 650-6967
Assistant: Alison Corshia
Saturday, May 9, 2020