RETAINED SEARCH: Sr. Medical Director (lead Ph 2 to NDA) - Late-Stage Biotech (Critical Care Immunotherapy): RTP, NC
Summary: Cornerstone Search Group’s Specialized MD Practice has been retained by a late-stage, pre-IPO biotech company whose lead clinical candidate’s lead indication is in Phase III. It is a first-in-class, “Fast Tracked” immunotherapy treatment for acute life-threatening conditions such as AKI and serious infections that can lead to loss of limb or life. They need a talented MD with industry or PI experience to join their growing team to lead an upcoming Phase II program through to NDA. This highly visible role reports to a personable and respected CMO and will be working right alongside the executive leadership team. Our client is backed by highly respected biotech venture capital companies.
Company: This well-funded, innovative, pre-IPO biotech has a well-proven leadership team with demonstrated success leading pre- & post-IPO companies.
Title: Senior Medical Director (Clinical R&D)
Location: Research Triangle Park, NC metro area
Attractive Features about this Position and Company:
- Gain Valuable Late Phase (II & III) & Regulatory Submissions (NDA & MAA) Experience
- Clinical Development Leadership Opportunity: You will have the opportunity to manage and lead an indication from Phase II inception through to NDA/MAA.
- The CMO is a willing mentor who has a lot of experience and very good communication skills.
- Visibility: You will work alongside the entire executive leadership team, getting to know and interacting meaningfully with the C-level executives.
- Innovative Company: This company is focused on innovative immunotherapy approaches to acute care indications such as AKI and life-threatening infections. Their lead compound in development is a first-in-class, internally developed candidate that has gained “Fast Track Status”.
- Small Company Culture: You will be working in a collegial, fast-paced environment where you’ll have the opportunity to learn all facets of clinical drug development rather than the more limited role an MD plays in a CRO or in a large pharma.
- Provide Medical/Clinical support for multiple indications of a late-stage asset, including leading an indication into Phase II through to NDA/MAA.
- Provide Medical/Clinical support for the preparation and review of regulatory documents (briefing documents for regulatory meetings, IND submissions/updates, NDA/MAA submissions).
- Provide medical leadership/support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents.
- Review and sign off on adverse events reports and provide reports to the FDA, European Regulatory Authorities, and other regulatory agencies.
- Provide support in preparation of Safety Update Reports (PSURs/DSURs).
- Review and sign off on Data Management listings of safety data (including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication), establish the presence or absence of clinically meaningful trends and, if noted, follow up as appropriate with the internal study team, investigator, and Regulatory Authorities.
- Medical leadership in responding to inquiry/questions, both internally and externally.
- Review all documents assigned for scientifically/medically relevant issues including drug safety.
- Attend and present material (such as therapeutic area training) as requested, at internal and external meetings (e.g. investigator meetings).
- Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
- Maintain up-to-date knowledge of therapeutic indications expertise by attending professional society meetings.
- An MD, MBBS, MBBCh, BMBS, MBChB, or DO degree is required.
- Ideal medical training backgrounds include Immunology, Surgical, Hospitalist, Emergency Medicine, Critical Care, Infectious Disease, Pediatrics and Internal Medicine.
- Seeking relevant Pharma / Biotech / CRO / academic clinical development experience. May consider a talented person with lighter experience for a Director title rather than Sr. Director.
- Ability to interact and collaborate cross-functionally
- Passion and desire to bring an innovative, life-saving clinical candidate to market.
Corey S. Ackerman, JD | Senior Partner
Lavinia C. Rodriguez
CORNERSTONE SEARCH GROUP - Life Sciences Executive Search
Six Campus Drive | Suite 301 | Parsippany, NJ 07054 USA
CH: 41 61 508 7010
Recently Completed MD Search Assignments:
- EVP, CMO – Clinical-Stage Oncology Biopharma – Boston Area
- VP, Head of Clinical Development – Clinical-Stage Oncology Biopharma – Boston Area
- EVP, Head of Oncology Global Medical Affairs – mid-size Global pharma – New Jersey
- Executive Director, Clinical Development, Oncology – small Global pharma – New Jersey
Keywords: surgery surgical immuno immunology anti-virus virology anti-infective, antiinfective, anti-biotic, antibiotic oncology cancer respiratory pediatrician clinical research physician clinical R&D dermatology executive director SD ED principal investigator