Clinical Development Director

Enveda Therapeutics, Inc.; Boulder (CO); On-site; USD 225,000 - 250,000; Full time

Job summary

Join a forward-thinking company as a Clinical Development Director, where your expertise in designing clinical studies will be pivotal in advancing innovative drug discovery. This role offers the opportunity to collaborate with a diverse team, contributing to the development of clinical strategies and regulatory submissions. You will play a critical role in shaping the future of healthcare by leveraging your clinical science knowledge and regulatory experience. With a commitment to employee well-being and a vibrant culture, this position promises to be both rewarding and impactful. If you are passionate about improving human health and making a difference, this is the perfect opportunity for you.

Benefits

Medical, dental, and vision insurance

401k matching

Flexible paid time off

Adoption assistance

Company-wide weeklong break

Qualifications

• 5+ years in clinical strategy development and execution.
• Experience in early phase studies and regulatory briefing documents.

Responsibilities

• Design clinical studies and development plans for drug trials.
• Collaborate with various teams for clinical program implementation.

Skills

Clinical Development

Regulatory Guidelines

Communication Skills

Immunology and Inflammation Knowledge

Education

MD, PhD, DO, PharmD or similar advanced degree

Job description

Enveda is looking for a Clinical Development Director to join our team!

The contribution you will make:

As the Clinical Development Director, you will leverage your experience in designing clinical studies to successfully bring drugs from the bench to the clinic. You will be part of a diverse team reporting to the SVP of clinical development contributing to our mission using advanced drug discovery platforms. The role will require you to use your knowledge of clinical science and FDA and other regulatory agency guidelines in support of clinical development of indications of interest to Enveda.

As a member of the Clinical team, you will report to the Sr. VP, Dermatology.

You get to collaborate on

• Clinical development activities including design of clinical studies, clinical development plans, investigator brochure, regulatory (FDA/EMA) briefing documents for Pre-IND/IND/NDA submissions, and other required clinical documents in the conduct of clinical trials
• Provide clinical research summaries on disease indications of interest to the company
• Provide clinical science and development expertise to the portfolio
• Partner with clinical operations in the conduct of clinical studies
• Collaborate with the drug discovery, pharmacology, translational science and regulatory group to design and implement development stage specific clinical program
• Provide clinical science insights into development programs and business development opportunities.

Who will thrive in this role?

• MD, PhD, DO, PharmD or similar advanced degree
• 5+ years industry experience in developing and executing the clinical strategies and contributing to clinical programs
• Clinical development experience in early phase studies, Phase-1 and Phase-2.
• Experience in developing clinical sections of the regulatory briefing document
• Exceptional communication, both verbal and written
• Experience in Immunology and Inflammation (I&I) related clinical programs is desired.
• If you don't meet all of the requirements listed here, we still encourage you to apply. No job description is perfect, and we might find an even more suitable opportunity that matches your experience.

What to expect in the interview process:

• HR Screen (30 minutes)
• Hiring Manager Interview (45 minutes)
• Technical interview (45 minutes)
• Work Sample Interview including presentation (60 minutes)
• Enveda Culture Interview (30 minutes)

Some of the total rewards of working here

• Culture: Enveda lives for people
• Salary: $225,000 - $250,000
• Equity
• Healthcare: Medical, dental and vision insurance. Company pays 90% of premium for employee and dependents
• 401k: Traditional or Roth 401k matching of 4% (100% of your contributions up to 4% of your annual compensation).
• PTO: Flexible paid time off (that we encourage and celebrate). Company-wide weeklong break to recharge. 10 observed holidays and 1 floating holiday.
• Adoption Assistance: At Enveda we want to celebrate and support employees who want to adopt children. We're excited to offer adoption assistance to employees who have completed the adoption process, including placement.

Come join us!

Our employees are the lifeblood of our work and our inspiration to press on. Together we've built a special place here—a drug discovery platform that's unique in the world with an incredible team collaborating in a creative, transformative culture. Our mission is to bring hope to patients everywhere. Our progress towards that goal would not be possible without talented people like you.

Employee Promise

Using our imagination and dedication, we are working to improve human health and give hope to patients everywhere. Our work together is empowering, trustable and collaborative, enabling you to do your best work.

Enveda's values

Curiosity: Learn and challenge.

Agency: Own and initiate.

Journey: Love the process.

Charity: Take care of each other.

Unity: We are one Enveda.

We value your uniqueness

One of life's gifts is to interact with a variety of people. Each of us has a unique story that shapes how we view the world, and solve problems. Learning from each other enhances our collective wisdom while achieving better outcomes at a faster clip. People from all kinds of backgrounds can succeed in all kinds of roles.

Our work environment appreciates the contributions of every person. Working together is how we produce results that illuminate our Purpose - To Deliver Hope To Every Patient. Unity is a company value because success depends on trusting, working relationships that respect the commonality and differences of people.

At Enveda we are building a place where every person can do the best work of their lifetime.

Enveda is an equal opportunity employer. We do not discriminate on the basis of characteristics protected by federal, state or local laws.