- Serve as the primary Medical Monitor for assigned clinical trials, ensuring medical and scientific quality of clinical trial execution.
- Establish and maintain relationships with site investigators to ensure appropriate medical execution of study protocols.
- Provides scientific/medical content and other input as appropriate for protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
- Provide ongoing medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and that appropriate responses are developed and executed.
- Review safety data to identify risk trends and present at functional meetings.
- Occasional travel for study–related and company meetings.
- Ensure compliance with regulatory standards and guidelines, including FDA requirements for MD sign–off on patient–related matters.
- Other duties as assigned. Ideal Candidate
- M.D. with clinical/translational research and/or drug development experience.
- A minimum of 2 years of experience in clinical development within the pharmaceutical or biotechnology industry. Experience in immune–mediated diseases desirable.
- Strong analytical and problem–solving skills.
- Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions. What We Offer
- Opportunity to work in a fast–paced, highly dynamic environment where you help shape the culture of our young company, wear multiple hats, and learn quickly.
- Market–competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Flexible PTO
- Two, one–week company–wide shutdowns each year.
- Commitment to growing you professionally and providing access to resources to further your development.
- 100% remote team with frequent in–person meetings to build relationships and problem solve. The expected salary range offer for this role is $245,000 to $289,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location. As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non–job–related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life–changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at How many years of related clinical pharmacology experience do you have within the pharmaceutical or biotechnology industry?
Please select Do you have a Ph.D. in Pharmacology, Pharmaceutical Sciences, or related field, with a strong focus on clinical pharmacology?
Please select what modalities you have related Clinical Pharmacology experience supporting:
Large Molecules
Small Molecules
Cell / Gene Therapy
Are you currently eligible to work in the U.S.?
Do you now or will you in the future require work authorization sponsorship to continue working in the U.S.?
Have you ever worked for Spyre Therapeutics or any of its affiliates in the past?
I certify that Spyre Therapeutics may collect and process my personal information as I provide it and pursuant to the terms of Spyre Therapeutic's "Candidate Privacy Statement", which is available here for my review Candidate Privacy Policy .
I further certify that the information I provide herein is accurate and that Spyre Therapeutics or its designee(s) may process it. -
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Medical Director, Clinical Development - Boston, United States - Spyre Therapeutics
Description
Spyre Therapeutics (NASDAQ: SYRE) is a biotechnology company aiming to address the needs of the millions of people living with inflammatory bowel disease (IBD) by advancing potentially best–in–class long–acting antibodies, rational therapeutic combinations, and precision immunology approaches. Spyre is advancing a robust portfolio that harnesses both proven and novel mechanisms of action for addressing IBD. The company's two parallel lead programs–SPY001 and SPY002–target ??4??7 and TL1A, respectively, and build upon the validation of these targets by existing commercial– and clinical–stage antibody therapeutics. The company's lead programs are projected to enter clinical studies in 2024. Role Summary
The Medical Director, Clinical Development will report into the SVP, Clinical Development and play a pivotal role as the clinical lead and medical monitor for our early–phase clinical trials. This individual will join the Clinical Development team in directing the clinical development program, formulating strategy to drive program success for our cutting–edge antibody portfolio. Key Responsibilities
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