Company Overview
Protara is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes.
Job Overview
The Medical Director, Clinical Development - Urology is responsible for providing oversight in the development and life cycle management for Protara’s lead program TARA-002 for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC). This individual requires leadership skills necessary for the strategy, development, management and execution/implementation of late-stage development studies.
**The location is either NYC Hybrid or remote.
Essential Duties and Responsibilities include the following (Other duties may be assigned):
- Serves as medical team leader for TARA-002 NMIBC studies
- Serves as Medical Monitor for TARA-002 NMIBC clinical trials
- Attends scientific meetings and fosters and develops strong relationships with urologic oncologists who are investigators and thought leaders.
- Assists with the development and implementation of publication strategies for products in development.
- Identifies and implements high value strategies for product life cycle development.
- Participates in multidisciplinary teams including alliance partners for strategic and tactical planning of in-line and products in development.
- Acts as a team leader for study design, implementation and timely completion of assigned clinical studies and helps address post-marketing research needs for Phase I-IV studies.
- Provides direction, training and follow-up to ensure compliance with department and corporate policies and procedures.
- Manages aggressive timelines; integrate scientific rigor, medical need and commercial value into clinical plans culminating in successful registration and marketing.
- Participates in strategic oversight and leadership for clinical development from proof of concept to BLA and/or NDA filing.
- Evaluates and recommends new strategic business opportunities and initiatives as they relate to TARA 002. The MD will be evaluating novel and cutting-edge technologies and determining new areas of scientific study that will add to and expand the Protara pipeline.
- Characterize business opportunities through scientific literature, Key Opinion Leader (KOL) and internal subject matter expert interviews, competitive intelligence, and additional secondary sources.
Education And Experience
- An MD is required.
- Strong oncology background is required. Urologist preferred.
- A minimum of two to five years progressive experience in pharmaceutical, biopharmaceutical or biotechnology drug development is preferred.
- Excellent understanding of the interdependencies of the various preclinical, clinical, regulatory and commercial disciplines is preferred.
Qualifications
- A proven ability to build productive relationships and teams both internally and externally and the ability to develop high-potential subordinates into leadership roles is critical and required.
- Ability to facilitate and merge strong science into commercially viable products is required.
- Prior experience in managing clinical trial conduct for oncology is strongly preferred
- Strong working knowledge of Good Clinical Practice, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies designated for review by regulatory authorities is strongly preferred.
- Willingness to join scientific organizations and to interact in scientific meetings.
Computer Skills
- Must be proficient in MS Office Suite.
Certificates, Licenses, Registrations: None required
Other Skills And Abilities
- Strong leadership and organizational skills.
- Excellent oral and written communication skills.
- Experience leading large projects/organizations.
- Energetic, flexible, enthusiastic and highly motivated.
- Able to work effectively with outside service providers.
- Ability to maintain high level of ethical and compliancy standards.
- Demonstrated ability to stay abreast of trends and new information in the profession
- Highly effective teamwork and interpersonal skills and the ability to work across numerous scientific disciplines.
**The Annual Salary Range is $200,000 - $275,000.
Physical Demands
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- This position requires travel (including overnight stays); average travel for this position is 25-30% with some variation based upon the demands of business imperatives. Travel is both domestic and international for internal and external business meetings.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
- No specific work demands.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Why You’ll Love Working at Protara
- Friendly, open, and fun team-oriented culture that values unique & diverse perspectives.
- Company-wide dedication to profoundly impacting patients’ lives.
- Amazing culture whereby core values and behaviors are shared cross-functionally.
- Competitive Salary and Benefits package includes incentive bonus, equity compensation, medical, dental, vision, commuter, and fertility benefits.
- Matching 401(k) Retirement Plan.
- Flexible working hours/schedule.
- Generous Paid Holidays and Unlimited PTO.
Protara is committed to being a diverse and inclusive workplace. Protara is an Equal Opportunity Employer and is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, creed, religion, national or ethnic origin, citizenship status, age, sex or gender, gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information or any other characteristic protected by applicable federal, state or local laws.
