RETAINED SEARCH: Medical Director, Late-Stage Biotech (Immunotherapy) – report to CMO : RTP, NC
Summary: Cornerstone Search Group’s Medical Director practice has been retained by the CMO of an innovative biotech company whose lead clinical candidate is a first-in-class, “Fast Tracked” immunotherapy treatment for life-treating conditions. Its lead indication is in Phase III and is for an “orphan” designated indication. In this highly visible role, you will report to a very experienced CMO who has very strong communication skills, and will be working right along with the executive leadership team. Given the smaller biotech environment, our client is seeking an MD who wants to “roll up their sleeves” and can positively collaborate cross-functionally within the organization.
Company: This well-funded, pre-IPO biotech has a well-proven leadership team with proven success leading pre-IPO companies and prior success in this therapeutic area.
Title: Medical Director or Associate Medical Director. Title depends upon experience
Location: Research Triangle Park, NC metro area
Attractive Features about this Position and Company:
- Gain Valuable Phase III & Regulatory Submissions Experience: You will have the opportunity to step in and gain experience (Ph. III and NDA) that is highly coveted within the industry. 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. 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 a Phase III program in an orphan indication.
- 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.
- Provide support for marketing activities as requested.
- An MD degree is required.
- Ideally seeking 2 to 5 years of relevant Pharma/Biotech/CRO clinical development
- Ability to interact and collaborate cross-functionally.
- Ability to be flexible and travel when needed, but not regularly.
Lavinia C. Rodriguez
CORNERSTONE SEARCH GROUP - Life Sciences Executive Search
Six Campus Drive | Parsippany, NJ 07054 USA
CH: 41 61 508 7010
Recently Completed MD Search Assignments:
- VP, Head of Clinical Development – Oncology Biotech
- EVP, Head of Oncology Global Medical Affairs – mid-size Global pharma
- Director, Clinical Development, Oncology – small Global pharma