Clinical Development Strategist
4 weeks ago
Our Company:
Evestra, Inc. is an emerging biopharmaceutical company that focuses on developing and commercializing women’s healthcare products. Based in San Antonio, Texas, Evestra’s mission is to improve the health and well-being of women around the world through innovative technologies and products.
Responsibilities:
- Develop and implement US and global clinical development strategies in line with regulatory and therapeutic requirements.
- Provide strategic input for clinical trial design in collaboration with CROs ensuring feasibility of study protocol.
- Closely collaborate with regulatory and key team members to ensure clinical protocols are in line with study and program objectives.
- Evaluate emerging regulatory requirements to optimize study success and mitigate risks.
- Conduct literature reviews to inform strategic decision-making and stay updated on regulatory landscapes.
- Act as a liaison between internal teams and regulatory agencies, ensuring clear communication.
- Contribute scientific content for study protocols, regulatory documents, and publications.
- Spearhead clinical expertise development and foster high-quality medical product development.
- Analyze clinical trial data to provide insights supporting decision-making.
- Provide scientific insight into study design and disease process and contribute to regulatory submissions.
- Provide scientific evidence to support strategic decision-making across R&D, marketing, and clinical development.
- Closely interact with clinical development CROs to ensure that the study is conducted according to industry standards and regulatory requirements.
- Author clinical sections of regulatory submissions.
Qualifications:
- Advanced degree in life sciences or related field (e.g., MD, PhD, PharmD).
- 10+ years of clinical development experience in pharmaceutical or biotechnology industry.
- Proven track record in developing successful clinical development strategies resulting in drug approval (NDA/IND/CTA).
- Strong knowledge of global regulatory guidelines, including FDA, EMA, and ICH regulations.
- Excellent communication and interpersonal skills for effective collaboration.
- Detail-oriented with strong analytical and problem-solving abilities.
- Self-motivated with the ability to prioritize tasks independently.
- Experience with regulatory submissions, including IND/CTA filings.
- Experience in Women’s Health preferred.
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts Management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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Clinical Development Strategist
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San Antonio, United States Evestra, Inc. Full timeOur Company:Evestra, Inc. is an emerging biopharmaceutical company that focuses on developing and commercializing women’s healthcare products. Based in San Antonio, Texas, Evestra’s mission is to improve the health and well-being of women around the world through innovative technologies and products. Responsibilities:Develop and implement US and global...
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